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    Clinical Trial Results:
    A Phase III, Randomized, Multicenter, Open-Label Study in Adolescent and Adult Participants Comparing the Efficacy and Safety of Gepotidacin to Ceftriaxone Plus Azithromycin in the Treatment of Uncomplicated Urogenital Gonorrhea Caused by Neisseria gonorrhoeae

    Summary
    EudraCT number
    		 2018-001780-23
    Trial protocol
    		 GB   DE  
    Global end of trial date
    10 Oct 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 May 2024
    First version publication date
    17 May 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BTZ116577
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04010539
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline
    Sponsor organisation address
    980 Great West Road, Brentford, Middlesex, United Kingdom, TW8 9GS
    Public contact
    GSK Response Center, GlaxoSmithKline, 1 8664357343, GSKClinicalSupportHD@gsk.com
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 1 8664357343, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-002443-PIP02-18
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    14 Feb 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Oct 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Oct 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    1)To evaluate the efficacy of oral gepotidacin compared to IM ceftriaxone plus oral azithromycin to treat participants with uncomplicated urogenital gonorrhea caused by Neisseria gonorrhoeae (NG) (2)To evaluate the efficacy of oral gepotidacin compared to IM ceftriaxone plus oral azithromycin to treat participants with rectal gonorrhea caused by NG (3) To evaluate the efficacy of oral gepotidacin compared to IM ceftriaxone plus oral azithromycin to treat participants with pharyngeal gonorrhea caused by NG (4) To evaluate the safety and tolerability of oral gepotidacin compared to IM ceftriaxone plus oral azithromycin
    Protection of trial subjects
    Not Applicable
    Background therapy
    		 Not Applicable
    Evidence for comparator
    		 -
    Actual start date of recruitment
    21 Oct 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 105
    Country: Number of subjects enrolled
    Germany: 139
    Country: Number of subjects enrolled
    Mexico: 15
    Country: Number of subjects enrolled
    United Kingdom: 98
    Country: Number of subjects enrolled
    United States: 85
    Country: Number of subjects enrolled
    Spain: 186
    Worldwide total number of subjects
    628
    EEA total number of subjects
    325
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    2
    Adults (18-64 years)
    623
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 None

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Gepotidacin
    Arm description
    		 Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4*750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4*750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Gepotidacin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4*750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4*750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.

    Arm title
    		 Ceftriaxone plus azithromycin
    Arm description
    		 Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive single dose of 500 mg Ceftriaxone as intramuscular sterile powder reconstituted with appropriate diluent plus single oral dose of 1 gram (g) Azithromycin (2*500 mg, tablets) on Day 1. Azithromycin was to be administered after food consumption and with water.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ceftriaxone plus azithromycin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet, Powder for injection
    Routes of administration
    Oral use, Intramuscular use
    Dosage and administration details
    Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive single dose of 500 mg Ceftriaxone as intramuscular sterile powder reconstituted with appropriate diluent plus single oral dose of 1 gram (g) Azithromycin (2*500 mg, tablets) on Day 1. Azithromycin was to be administered after food consumption and with water.

    Number of subjects in period 1
    		Gepotidacin Ceftriaxone plus azithromycin
    Started
    314
    314
    Safety population
    309
    313
    Microbiological ITT(Micro-ITT)population
    202 [1]
    204 [2]
    Micro-ITT Rectal population
    26 [3]
    15 [4]
    Micro-ITT Pharyngeal population
    18 [5]
    17 [6]
    Completed
    294
    295
    Not completed
    20
    19
         Consent withdrawn by subject
    4
    1
         Physician decision
    -
    2
         Adverse event, non-fatal
    3
    -
         Protocol Deviation
    -
    1
         Randomized in Error/ Mistake
    2
    -
         Participant Did Not Receive IP
    -
    1
         Lost to follow-up
    10
    14
         Eligibility Criteria Unable to Evaluate
    1
    -
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Intermediate milestones are a subset of started population. Hence number of participants at the milestones are less than started.
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Intermediate milestones are a subset of started population. Hence number of participants at the milestones are less than started.
    [3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Intermediate milestones are a subset of started population. Hence number of participants at the milestones are less than started.
    [4] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Intermediate milestones are a subset of started population. Hence number of participants at the milestones are less than started.
    [5] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Intermediate milestones are a subset of started population. Hence number of participants at the milestones are less than started.
    [6] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Intermediate milestones are a subset of started population. Hence number of participants at the milestones are less than started.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Gepotidacin
    Reporting group description
    		 Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4*750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4*750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.

    Reporting group title
    Ceftriaxone plus azithromycin
    Reporting group description
    		 Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive single dose of 500 mg Ceftriaxone as intramuscular sterile powder reconstituted with appropriate diluent plus single oral dose of 1 gram (g) Azithromycin (2*500 mg, tablets) on Day 1. Azithromycin was to be administered after food consumption and with water.

    Reporting group values
    		 Gepotidacin Ceftriaxone plus azithromycin Total
    Number of subjects
    		 314 314 628
    Age categorical
    Units: Participants
        12-84 years
    		 314 314 628
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 33.9 ( 10.42 ) 33.7 ( 10.70 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 35 34 69
        Male
    		 279 280 559
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 9 10 19
        Asian
    		 12 17 29
        Native Hawaiian or Other Pacific Islander
    		 7 2 9
        Black or African American
    		 49 39 88
        White
    		 231 241 472
        More than one race
    		 6 5 11
        Unknown or Not Reported
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Gepotidacin
    Reporting group description
    		 Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4*750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4*750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.

    Reporting group title
    Ceftriaxone plus azithromycin
    Reporting group description
    		 Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive single dose of 500 mg Ceftriaxone as intramuscular sterile powder reconstituted with appropriate diluent plus single oral dose of 1 gram (g) Azithromycin (2*500 mg, tablets) on Day 1. Azithromycin was to be administered after food consumption and with water.

    Primary: Number of Participants with Culture-Confirmed Bacterial Eradication of Neisseria Gonorrhoeae (NG) From the Urogenital Site at the Test-Of-Cure (TOC) Visit (Day 4 to 8) - Micro-ITT population

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    End point title
    		 Number of Participants with Culture-Confirmed Bacterial Eradication of Neisseria Gonorrhoeae (NG) From the Urogenital Site at the Test-Of-Cure (TOC) Visit (Day 4 to 8) - Micro-ITT population
    End point description
    Urogenital specimens obtained for bacteriological culture at Baseline and TOC visits were compared to determine microbiological outcome. Microbiological Success: Culture-confirmed elimination of baseline NG from a bacteriology sample taken at TOC visit without participant receiving other systemic antimicrobials before this visit. Microbiological Failure categorized as Bacterial Persistence (BP): Culture-confirmed persistence of baseline NG pathogen from a bacteriology sample taken at TOC visit without the participant receiving other systemic antimicrobials before this visit. Unable To Determine (UTD): Inability to determine TOC NG pathogen outcome (e.g no bacteriological sample taken for culture, sample lost, visit did not occur etc) or participant received other systemic antimicrobials before the TOC visit.
    End point type
    Primary
    End point timeframe
    Baseline (Day 1) and TOC visit (Day 4 to 8)
    End point values
    		 Gepotidacin Ceftriaxone plus azithromycin
    Number of subjects analysed
    202
    204
    Units: Participants
        Microbiological success
    187
    186
        Microbiological failure, BP
    0
    0
        Microbiological failure, UTD
    15
    18
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    The difference in microbiological success rates between treatment groups (Gepotidacin - Ceftriaxone plus azithromycin) was calculated using the Miettinen-Nurminen Summary Score Method adjusted for sex and sexual orientation combination. Superiority was declared if the lower limit of the 2-sided 95% confidence interval for the difference was above 0.0%.
    Comparison groups
    Gepotidacin v Ceftriaxone plus azithromycin
    Number of subjects included in analysis
    406
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5072
    Method
    		 1-sided p-value for TestOfSuperiority
    Parameter type
    		 Adjusted Difference in Percent
    Point estimate
    -0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.6
         upper limit
    		 5.5
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    The difference in microbiological success rates between treatment groups (Gepotidacin - Ceftriaxone plus azithromycin) was calculated using the Miettinen-Nurminen Summary Score Method adjusted for sex and sexual orientation combination. Non-inferiority was declared if the lower limit of the 2-sided 95% confidence interval for the difference was above -10.0%.
    Comparison groups
    Gepotidacin v Ceftriaxone plus azithromycin
    Number of subjects included in analysis
    406
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Adjusted Difference in Percent
    Point estimate
    -0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.6
         upper limit
    		 5.5

    Secondary: Number of Participants with Culture-Confirmed Bacterial Eradication of NG From the Rectal Site at the TOC visit - Micro-ITT rectal population

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    End point title
    		 Number of Participants with Culture-Confirmed Bacterial Eradication of NG From the Rectal Site at the TOC visit - Micro-ITT rectal population
    End point description
    Urogenital specimens obtained for bacteriological culture at Baseline and TOC visits were compared to determine microbiological outcome. Microbiological Success: Culture-confirmed elimination of baseline NG from a bacteriology sample taken at the TOC visit without participant receiving other systemic antimicrobials before this visit. Microbiological Failure categorized as BP: Culture-confirmed persistence of baseline NG pathogen from a bacteriology sample taken at the TOC visit without the participant receiving other systemic antimicrobials before this visit. UTD: Inability to determine the TOC NG pathogen outcome (e.g., no bacteriological sample taken for culture, sample lost, visit did not occur etc.) or participant received other systemic antimicrobials before the TOC visit. Micro-ITT Rectal population: participants who met the definition of the Micro-ITT and have confirmed NG isolated that is ceftriaxone susceptible from baseline culture of their rectal specimen.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and TOC visit (Day 4 to 8)
    End point values
    		 Gepotidacin Ceftriaxone plus azithromycin
    Number of subjects analysed
    26
    15
    Units: Participants
        Microbiological success
    26
    12
        Microbiological failure, BP
    0
    0
        Microbiological failure, UTD
    0
    3
    No statistical analyses for this end point

    Secondary: Number of participants with any treatment-emergent adverse events (TEAEs) and any serious adverse events (SAEs) - Safety population

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    End point title
    		 Number of participants with any treatment-emergent adverse events (TEAEs) and any serious adverse events (SAEs) - Safety population
    End point description
    An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A TEAE is an event that emerges during treatment having been absent pretreatment or worsens relative to the pretreatment state. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; was a congenital anomaly/birth defect.
    End point type
    Secondary
    End point timeframe
    Up to 21 days
    End point values
    		 Gepotidacin Ceftriaxone plus azithromycin
    Number of subjects analysed
    309
    313
    Units: Participants
        Any TEAEs
    230
    104
        Any SAEs
    1
    0
    No statistical analyses for this end point

    Secondary: Number of Participants with Culture-Confirmed Bacterial Eradication of NG from the Pharyngeal Site at the TOC visit - Micro-ITT pharyngeal population

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    End point title
    		 Number of Participants with Culture-Confirmed Bacterial Eradication of NG from the Pharyngeal Site at the TOC visit - Micro-ITT pharyngeal population
    End point description
    Urogenital specimens obtained for bacteriological culture at Baseline and TOC visits were compared to determine microbiological outcome. Microbiological Success: Culture-confirmed elimination of baseline NG from a bacteriology sample taken at the TOC visit without participant receiving other systemic antimicrobials before this visit. Microbiological Failure categorized as BP: Culture-confirmed persistence of baseline NG pathogen from a bacteriology sample taken at the TOC visit without the participant receiving other systemic antimicrobials before this visit. UTD: Inability to determine the TOC NG pathogen outcome (e.g., no bacteriological sample taken for culture, sample lost, visit did not occur etc.) or participant received other systemic antimicrobials before the TOC visit. Micro-ITT Pharyngeal population:participants who met the definition of the Micro-ITT Population and have confirmed NG isolated that is ceftriaxone susceptible from baseline culture of their pharyngeal specimen
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and TOC visit (Day 4 to 8)
    End point values
    		 Gepotidacin Ceftriaxone plus azithromycin
    Number of subjects analysed
    18
    17
    Units: Participants
        Microbiological success
    14
    16
        Microbiological failure, BP
    2
    0
        Microbiological failure, UTD
    2
    1
    No statistical analyses for this end point

    Secondary: Change from Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes - Safety population

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    End point title
    		 Change from Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Neutrophils, Platelets, Lymphocytes, Monocytes, Neutrophils and Nucleated Erythrocytes - Safety population
    End point description
    Blood samples were collected for the assessment of change from baseline in hematology parameters: basophils, eosinophil, leukocytes, neutrophils, platelets, lymphocytes, monocytes, neutrophils and nucleated erythrocytes. Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and TOC visit (Day 4 to 8)
    End point values
    		 Gepotidacin Ceftriaxone plus azithromycin
    Number of subjects analysed
    284
    293
    Units: Giga cells per liter (10^9 cells/L)
    arithmetic mean (standard deviation)
        Basophils, Baseline (Day 1)
    0.044 ( 0.0196 )
    0.045 ( 0.0222 )
        Basophils, CFB to TOC
    0.001 ( 0.0167 )
    0.000 ( 0.0152 )
        Eosinophils, Baseline (Day 1)
    0.154 ( 0.2117 )
    0.160 ( 0.1384 )
        Eosinophils, CFB to TOC
    0.009 ( 0.1289 )
    0.018 ( 0.0827 )
        Leukocytes, Baseline (Day 1)
    7.143 ( 2.2808 )
    7.507 ( 2.2045 )
        Leukocytes, CFB to TOC
    -0.811 ( 1.8536 )
    -1.267 ( 1.9362 )
        Neutrophils, Baseline (Day 1)
    4.443 ( 1.9621 )
    4.774 ( 1.9355 )
        Neutrophils, CFB to TOC
    -1.062 ( 1.7309 )
    -1.473 ( 1.8860 )
        Platelets, Baseline (Day 1)
    260.3 ( 61.79 )
    268.4 ( 69.26 )
        Platelets, CFB to TOC
    10.2 ( 32.14 )
    9.7 ( 34.94 )
        Lymphocytes, Baseline (Day 1)
    1.934 ( 0.5941 )
    1.948 ( 0.6321 )
        Lymphocytes, CFB to TOC
    0.277 ( 0.5205 )
    0.245 ( 0.5511 )
        Monocytes, Baseline (Day 1)
    0.559 ( 0.2209 )
    0.572 ( 0.1877 )
        Monocytes, CFB to TOC
    -0.034 ( 0.1917 )
    -0.053 ( 0.1782 )
        Nucleated Erythrocytes, Baseline (Day 1)
    0.002 ( 0.0047 )
    0.001 ( 0.0038 )
        Nucleated Erythrocytes, CFB to TOC
    0.000 ( 0.0070 )
    0.001 ( 0.0059 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Hematology Parameters: Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) - Safety population

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    End point title
    		 Change from Baseline in Hematology Parameters: Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) - Safety population
    End point description
    Blood samples were collected for the assessment of change from baseline in hematology parameters: mean corpuscular hemoglobin concentration and hemoglobin. Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and TOC visit (Day 4 to 8)
    End point values
    		 Gepotidacin Ceftriaxone plus azithromycin
    Number of subjects analysed
    284
    293
    Units: Grams per liter (g/L)
    arithmetic mean (standard deviation)
        MCHC, Baseline (Day 1)
    318.5 ( 16.27 )
    318.8 ( 16.12 )
        MCHC, CFB to TOC
    2.4 ( 10.67 )
    0.3 ( 11.27 )
        Hb, Baseline (Day 1)
    149.1 ( 12.83 )
    149.2 ( 12.58 )
        Hb, CFB to TOC
    0.00 ( 6.70 )
    0.6 ( 6.92 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Hematology Parameter: Hematocrit - Safety population

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    End point title
    		 Change from Baseline in Hematology Parameter: Hematocrit - Safety population
    End point description
    Blood samples were collected for the assessment of change from baseline in hematology parameter: hematocrit. Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and TOC visit (Day 4 to 8)
    End point values
    		 Gepotidacin Ceftriaxone plus azithromycin
    Number of subjects analysed
    284
    293
    Units: Percentage
    arithmetic mean (standard deviation)
        Baseline (Day 1)
    0.4691 ( 0.04205 )
    0.4687 ( 0.04104 )
        CFB to TOC
    -0.0038 ( 0.02526 )
    0.0012 ( 0.02666 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Hematology Parameter: Erythrocytes - Safety population

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    End point title
    		 Change from Baseline in Hematology Parameter: Erythrocytes - Safety population
    End point description
    Blood samples were collected for the assessment of change from baseline in hematology parameter: red blood cell (RBC) count. Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and TOC visit (Day 4 to 8)
    End point values
    		 Gepotidacin Ceftriaxone plus azithromycin
    Number of subjects analysed
    284
    293
    Units: Trillion cells per liter (10^12 cells/L)
    arithmetic mean (standard deviation)
        Baseline (Day 1)
    4.911 ( 0.4722 )
    4.926 ( 0.4601 )
        CFB to TOC
    0.003 ( 0.2261 )
    0.019 ( 0.2332 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Hematology Parameter: Mean Corpuscular Volume (MCV) - Safety population

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    End point title
    		 Change from Baseline in Hematology Parameter: Mean Corpuscular Volume (MCV) - Safety population
    End point description
    Blood samples were collected for the assessment of change from baseline in hematology parameter: mean corpuscular volume (MCV). Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and TOC visit (Day 4 to 8)
    End point values
    		 Gepotidacin Ceftriaxone plus azithromycin
    Number of subjects analysed
    284
    293
    Units: Femtoliters (fL)
    arithmetic mean (standard deviation)
        Baseline (Day 1)
    95.79 ( 6.266 )
    95.43 ( 6.760 )
        CFB to TOC
    -0.85 ( 3.104 )
    -0.12 ( 3.084 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin (MCH) - Safety population

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    End point title
    		 Change from Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin (MCH) - Safety population
    End point description
    Blood samples were collected for the assessment of change from baseline in hematology parameter: mean corpuscular hemoglobin (MCH). Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and TOC visit (Day 4 to 8)
    End point values
    		 Gepotidacin Ceftriaxone plus azithromycin
    Number of subjects analysed
    284
    293
    Units: Picograms (pg)
    arithmetic mean (standard deviation)
        Baseline (Day 1)
    30.46 ( 1.978 )
    30.38 ( 1.987 )
        CFB to TOC
    -0.03 ( 0.451 )
    0.00 ( 0.594 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Clinical Chemistry Parameters: Urea Nitrogen (UN), Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium - Safety population

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    End point title
    		 Change from Baseline in Clinical Chemistry Parameters: Urea Nitrogen (UN), Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium - Safety population
    End point description
    Blood samples were collected for the assessment of change from baseline in clinincal chemistry parameters: urea nitrogen (UN), glucose, calcium, chloride, sodium, magnesium and potassium. Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and TOC visit (Day 4 to 8)
    End point values
    		 Gepotidacin Ceftriaxone plus azithromycin
    Number of subjects analysed
    304
    306
    Units: Millimoles per liter (mmol/L)
    arithmetic mean (standard deviation)
        UN, Baseline (Day 1)
    4.793 ( 1.4293 )
    4.800 ( 1.4669 )
        UN, CFB to TOC
    0.190 ( 1.1640 )
    0.282 ( 1.1920 )
        Glucose, Baseline
    5.049 ( 1.0557 )
    5.090 ( 1.1183 )
        Glucose, CFB to TOC
    0.227 ( 0.9425 )
    0.064 ( 0.9684 )
        Calcium, Baseline (Day 1)
    2.387 ( 0.0986 )
    2.387 ( 0.0954 )
        Calcium, CFB to TOC
    -0.009 ( 0.0852 )
    -0.015 ( 0.0871 )
        Chloride, Baseline (Day 1)
    101.7 ( 2.26 )
    101.7 ( 2.30 )
        Chloride, CFB to TOC
    0.7 ( 2.57 )
    0.5 ( 2.40 )
        Sodium, Baseline (Day 1)
    139.6 ( 2.11 )
    139.6 ( 2.02 )
        Sodium, CFB to TOC
    0.2 ( 2.19 )
    0.1 ( 2.44 )
        Magnesium, Baseline (Day 1)
    0.854 ( 0.0612 )
    0.855 ( 0.0637 )
        Magnesium, CFB to TOC
    -0.003 ( 0.0604 )
    -0.004 ( 0.0584 )
        Potassium, Baseline (Day 1)
    4.29 ( 0.323 )
    4.30 ( 0.332 )
        Potassium, CFB to TOC
    -0.04 ( 0.336 )
    -0.03 ( 0.345 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Clinical Chemistry Parameters: Bilirubin, Direct Bilirubin and Creatinine - Safety population

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    End point title
    		 Change from Baseline in Clinical Chemistry Parameters: Bilirubin, Direct Bilirubin and Creatinine - Safety population
    End point description
    Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters: bilirubin, direct bilirubin and creatinine levels. Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and TOC visit (Day 4 to 8)
    End point values
    		 Gepotidacin Ceftriaxone plus azithromycin
    Number of subjects analysed
    303
    305
    Units: Micromoles per liter (umol/L)
    arithmetic mean (standard deviation)
        Bilirubin, Baseline (Day 1)
    8.54 ( 5.861 )
    7.71 ( 4.806 )
        Bilirubin, CFB to TOC
    -0.05 ( 5.025 )
    -0.14 ( 3.914 )
        Direct Bilirubin, Baseline (Day 1)
    3.83 ( 1.248 )
    3.76 ( 1.210 )
        Direct Bilirubin, CFB to TOC
    -0.02 ( 0.897 )
    0.01 ( 0.876 )
        Creatinine, Baseline (Day 1)
    75.9 ( 34.12 )
    75.0 ( 20.63 )
        Creatinine, CFB to TOC
    -0.2 ( 34.08 )
    2.6 ( 9.52 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) - Safety population

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    End point title
    		 Change from Baseline in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) - Safety population
    End point description
    Blood samples were collected for the assessment of change from baseline in clinincal chemistry parameters: aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase (ALP). Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and TOC visit (Day 4 to 8)
    End point values
    		 Gepotidacin Ceftriaxone plus azithromycin
    Number of subjects analysed
    303
    305
    Units: International units per Liter (IU/L)
    arithmetic mean (standard deviation)
        AST, Baseline (Day 1)
    24.4 ( 15.30 )
    24.2 ( 16.29 )
        AST, CFB to TOC
    2.8 ( 19.51 )
    0.9 ( 13.25 )
        ALT, Baseline (Day 1)
    23.7 ( 18.78 )
    23.7 ( 14.35 )
        ALT, CFB to TOC
    1.4 ( 12.59 )
    1.1 ( 7.64 )
        ALP, Baseline (Day 1)
    76.0 ( 20.86 )
    77.1 ( 26.53 )
        ALP, CFB to TOC
    -0.4 ( 7.73 )
    -1.5 ( 7.80 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Clinical Chemistry Parameters: Albumin and Protein - Safety population

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    End point title
    		 Change from Baseline in Clinical Chemistry Parameters: Albumin and Protein - Safety population
    End point description
    Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters: albumin and protein. Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and TOC visit (Day 4 to 8)
    End point values
    		 Gepotidacin Ceftriaxone plus azithromycin
    Number of subjects analysed
    305
    306
    Units: Grams per liter (g/L)
    arithmetic mean (standard deviation)
        Albumin, Baseline (Day 1)
    46.9 ( 3.12 )
    46.8 ( 3.19 )
        Albumin, CFB to TOC
    -0.3 ( 2.35 )
    -0.3 ( 2.67 )
        Protein, Baseline (Day 1)
    73.1 ( 4.80 )
    73.3 ( 4.85 )
        Protein, CFB to TOC
    -0.5 ( 3.86 )
    -0.5 ( 4.02 )
    No statistical analyses for this end point

    Secondary: Number of Participants with Urinalysis Dipstick Results - Safety population

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    End point title
    		 Number of Participants with Urinalysis Dipstick Results - Safety population
    End point description
    Urine samples were collected for urinalysis: Glucose, Protein, Occult Blood and Ketones. The dipstick test gives results in a semi-quantitative manner, and results can be read as Negative, Small, Moderate, Large, Positive, 5 milligram per deciliter (mg/dL), 20 mg/dL, 30 mg/dL 50 mg/dL, 100 mg/dL, 150 mg/dL and >=500 mg/dL indicating concentrations in the urine sample. In the row title (Glucose, Baseline, Negative), Glucose indicates parameter, Baseline is the visit and Negative indicates the concentration in the urine sample. Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and TOC visit (Day 4 to 8)
    End point values
    		 Gepotidacin Ceftriaxone plus azithromycin
    Number of subjects analysed
    299
    307
    Units: Participants
        Glucose, Baseline (Day 1), Negative
    296
    305
        Glucose, Baseline (Day 1), 150 mg/dL
    0
    0
        Glucose, Baseline (Day 1), >=500 mg/dL
    3
    2
        Glucose, TOC, Negative
    284
    283
        Glucose, TOC, 150 mg/dL
    1
    1
        Glucose, TOC, >=500 mg/dL
    2
    1
        Ketones, Baseline (Day 1), Negative
    288
    300
        Ketones, Baseline (Day 1), 5 mg/dL
    10
    7
        Ketones, Baseline (Day 1), 20 mg/dL
    1
    0
        Ketones, TOC, Negative
    279
    279
        Ketones, TOC, 5 mg/dL
    7
    6
        Ketones, TOC, 20 mg/dL
    1
    0
        Occult Blood, Baseline (Day 1), Negative
    202
    192
        Occult Blood, Baseline (Day 1), Small
    77
    91
        Occult Blood, Baseline (Day 1), Moderate
    18
    19
        Occult Blood, Baseline (Day 1), Large
    2
    5
        Occult Blood, TOC, Negative
    251
    252
        Occult Blood, TOC, Small
    30
    24
        Occult Blood, TOC, Moderate
    3
    6
        Occult Blood, TOC, Large
    3
    3
        Protein, Baseline (Day 1), Negative
    212
    210
        Protein, Baseline (Day 1), 30 mg/dL
    79
    83
        Protein, Baseline (Day 1), 100 mg/dL
    8
    13
        Protein, Baseline (Day 1), >=500 mg/dL
    0
    1
        Protein, TOC, Negative
    239
    244
        Protein, TOC, 30 mg/dL
    46
    37
        Protein, TOC, 100 mg/dL
    2
    4
        Protein, TOC, >=500 mg/dL
    0
    0
    No statistical analyses for this end point

    Secondary: Change from Baseline in Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) - Safety population

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    End point title
    		 Change from Baseline in Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) - Safety population
    End point description
    SBP and DBP were measured in a semi-supine position after 5 minutes rest. Baseline (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and TOC visit (Day 4 to 8)
    End point values
    		 Gepotidacin Ceftriaxone plus azithromycin
    Number of subjects analysed
    307
    313
    Units: Millimeters of mercury (mmHg)
    arithmetic mean (standard deviation)
        SBP, Baseline (Day 1)
    123.9 ( 13.69 )
    125.1 ( 14.41 )
        SBP, CFB to TOC
    -0.4 ( 12.61 )
    -0.5 ( 12.86 )
        DBP, Baseline (Day 1)
    76.7 ( 10.77 )
    77.2 ( 10.50 )
        DBP, CFB to TOC
    0.1 ( 9.10 )
    -0.9 ( 9.54 )
    No statistical analyses for this end point

    Secondary: Absolute Values in Potential of Hydrogen (pH) of Urine - Safety population

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    End point title
    		 Absolute Values in Potential of Hydrogen (pH) of Urine - Safety population
    End point description
    Urine samples were collected from participants to assess urine pH. Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and TOC visit (Day 4 to 8)
    End point values
    		 Gepotidacin Ceftriaxone plus azithromycin
    Number of subjects analysed
    299
    307
    Units: pH
    arithmetic mean (standard deviation)
        Baseline (Day 1)
    5.6 ( 0.69 )
    5.6 ( 0.70 )
        TOC
    5.5 ( 0.64 )
    5.4 ( 0.62 )
    No statistical analyses for this end point

    Secondary: Absolute Values in Specific Gravity of Urine - Safety population

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    End point title
    		 Absolute Values in Specific Gravity of Urine - Safety population
    End point description
    Urine samples were collected from participants to assess urine specific gravity. Baseline (Day 1) was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and TOC visit (Day 4 to 8)
    End point values
    		 Gepotidacin Ceftriaxone plus azithromycin
    Number of subjects analysed
    299
    307
    Units: Ratio
    arithmetic mean (standard deviation)
        Baseline (Day 1)
    1.0211 ( 0.00750 )
    1.0207 ( 0.00747 )
        TOC
    1.0211 ( 0.00720 )
    1.0216 ( 0.00748 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Vital Sign: Pulse Rate - Safety population

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    End point title
    		 Change from Baseline in Vital Sign: Pulse Rate - Safety population
    End point description
    Pulse rate was measured in a semi-supine position after 5 minutes rest. Baseline (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and TOC visit (Day 4 to 8)
    End point values
    		 Gepotidacin Ceftriaxone plus azithromycin
    Number of subjects analysed
    308
    313
    Units: Beats per minute
    arithmetic mean (standard deviation)
        Baseline (Day 1)
    73.0 ( 12.24 )
    72.8 ( 12.20 )
        CFB to TOC
    2.2 ( 12.44 )
    2.4 ( 12.33 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Vital Sign: Temperature - Safety population

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    End point title
    		 Change from Baseline in Vital Sign: Temperature - Safety population
    End point description
    Temperature was measured after 5 minutes rest. Baseline (Day 1) is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and TOC visit (Day 4 to 8)
    End point values
    		 Gepotidacin Ceftriaxone plus azithromycin
    Number of subjects analysed
    306
    313
    Units: Celsius (C)
    arithmetic mean (standard deviation)
        Baseline (Day 1)
    36.45 ( 0.395 )
    36.44 ( 0.457 )
        CFB to TOC
    -0.03 ( 0.381 )
    -0.06 ( 0.485 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 through the final follow-up visit (up to 21Days)
    Adverse event reporting additional description
    Safety population included all participants who received at least 1 dose of study treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.1
    Reporting groups
    Reporting group title
    Ceftriaxone plus azithromycin
    Reporting group description
    		 Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive single dose of 500 mg Ceftriaxone as intramuscular sterile powder reconstituted with appropriate diluent plus single oral dose of 1 gram (g) Azithromycin (2*500 mg, tablets) on Day 1. Azithromycin was to be administered after food consumption and with water.

    Reporting group title
    Gepotidacin
    Reporting group description
    		 Participants with uncomplicated urogenital gonorrhea (GC) were randomized to receive first dose of 3000 milligram (mg) (4*750 mg, tablets) gepotidacin orally on Day 1. Participants self-administered second dose of 3000 mg (4*750 mg, tablets) gepotidacin orally 10-12 hours after first dose. All doses were to be administered after food consumption and with water.

    Serious adverse events
    		 Ceftriaxone plus azithromycin Gepotidacin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 313 (0.00%)
    1 / 309 (0.32%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Lower limb fracture
         subjects affected / exposed
    0 / 313 (0.00%)
    1 / 309 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Ceftriaxone plus azithromycin Gepotidacin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    81 / 313 (25.88%)
    230 / 309 (74.43%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    8 / 313 (2.56%)
    10 / 309 (3.24%)
         occurrences all number
    8
    10
    Dizziness
         subjects affected / exposed
    2 / 313 (0.64%)
    16 / 309 (5.18%)
         occurrences all number
    2
    19
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 313 (0.00%)
    8 / 309 (2.59%)
         occurrences all number
    0
    9
    Injection site pain
         subjects affected / exposed
    5 / 313 (1.60%)
    0 / 309 (0.00%)
         occurrences all number
    5
    0
    Eye disorders
    Vision blurred
         subjects affected / exposed
    0 / 313 (0.00%)
    6 / 309 (1.94%)
         occurrences all number
    0
    6
    Gastrointestinal disorders
    Flatulence
         subjects affected / exposed
    1 / 313 (0.32%)
    20 / 309 (6.47%)
         occurrences all number
    1
    20
    Vomiting
         subjects affected / exposed
    2 / 313 (0.64%)
    20 / 309 (6.47%)
         occurrences all number
    2
    21
    Nausea
         subjects affected / exposed
    9 / 313 (2.88%)
    73 / 309 (23.62%)
         occurrences all number
    9
    80
    Diarrhoea
         subjects affected / exposed
    30 / 313 (9.58%)
    151 / 309 (48.87%)
         occurrences all number
    30
    167
    Abdominal distension
         subjects affected / exposed
    2 / 313 (0.64%)
    5 / 309 (1.62%)
         occurrences all number
    2
    5
    Faeces soft
         subjects affected / exposed
    1 / 313 (0.32%)
    16 / 309 (5.18%)
         occurrences all number
    1
    16
    Abdominal Pain
         subjects affected / exposed
    3 / 313 (0.96%)
    16 / 309 (5.18%)
         occurrences all number
    4
    17
    Abdominal discomfort
         subjects affected / exposed
    2 / 313 (0.64%)
    4 / 309 (1.29%)
         occurrences all number
    2
    4
    Abdominal pain upper
         subjects affected / exposed
    1 / 313 (0.32%)
    6 / 309 (1.94%)
         occurrences all number
    1
    6
    Skin and subcutaneous tissue disorders
    Hyperhidrosis
         subjects affected / exposed
    0 / 313 (0.00%)
    7 / 309 (2.27%)
         occurrences all number
    0
    8
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    4 / 313 (1.28%)
    0 / 309 (0.00%)
         occurrences all number
    4
    0
    Proctitis chlamydial
         subjects affected / exposed
    1 / 313 (0.32%)
    4 / 309 (1.29%)
         occurrences all number
    1
    4
    Urethritis chlamydial
         subjects affected / exposed
    0 / 313 (0.00%)
    6 / 309 (1.94%)
         occurrences all number
    0
    6
    Chlamydial infection
         subjects affected / exposed
    10 / 313 (3.19%)
    12 / 309 (3.88%)
         occurrences all number
    10
    12

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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