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    Clinical Trial Results:
    Phase 3 Study of IV to Oral 6-Day Tedizolid Phosphate Compared with 10-Day Comparator in Subjects 12 to <18 Years with cSSTI

    Summary
    EudraCT number
    		 2014-004023-40
    Trial protocol
    		 SI   BG   DE   CZ   LT   LV   ES   PL   Outside EU/EEA  
    Global end of trial date
    17 Sep 2018

    Results information
    Results version number
    		 v2(current)
    This version publication date
    08 Nov 2019
    First version publication date
    23 Mar 2019
    Other versions
    		 v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    MK-1986-012
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02276482
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Cubist Protocol Number: TR701-122, Merck Protocol Number: MK-1986-012
    Sponsors
    Sponsor organisation name
    Cubist Pharmaceuticals LLC
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001379-PIP01-12
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    17 Sep 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 Sep 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Sep 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of the study is to compare the safety of intravenous (IV) and/or oral 6-day 200 mg tedizolid phosphate with 10-day comparator in participants 12 to <18 years with complicated skin and soft tissue infection (cSSTI).
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research. The following additional measure defined for this individual study was in place for the protection of trial subjects: the investigator may discontinue study medication and initiate rescue medication for the treatment of a gram negative pathogen.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 Mar 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Bulgaria: 29
    Country: Number of subjects enrolled
    Georgia: 38
    Country: Number of subjects enrolled
    Latvia: 9
    Country: Number of subjects enrolled
    Lithuania: 4
    Country: Number of subjects enrolled
    Poland: 4
    Country: Number of subjects enrolled
    Spain: 1
    Country: Number of subjects enrolled
    Ukraine: 9
    Country: Number of subjects enrolled
    United States: 10
    Country: Number of subjects enrolled
    South Africa: 16
    Worldwide total number of subjects
    120
    EEA total number of subjects
    47
    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)
    120
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Participants included in the study were age 12 years to <18 years; had adequate venous access for intravenous (IV) administration of study drug for at least 24 hours (for participants receiving IV medication) and collection of protocol specified blood samples, and had cSSTI meeting at least 1 of the clinical syndrome definitions.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Assessor [1]

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Tedizolid Phosphate
    Arm description
    		 Tedizolid Phosphate IV and/or oral 200 mg once per day for 6 days. Participants with gram-negative wound infection may receive aztreonam (IV) and/or metronidazole (IV or oral).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tedizolid Phosphate
    Investigational medicinal product code
    Other name
    TR701-122, MK-1986, SIVEXTRO®
    Pharmaceutical forms
    Infusion, Tablet
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    200 mg administered daily for 6 days

    Investigational medicinal product name
    Metronidazole
    Investigational medicinal product code
    Other name
    Flagyl, Metro
    Pharmaceutical forms
    Injection, Tablet
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    Adjunctive metronidazole may be initiated on Day 1 or during the first 3 days of treatment if the participant is determined or suspected to have an infection with an anaerobic pathogen.

    Investigational medicinal product name
    Aztreonam
    Investigational medicinal product code
    Other name
    Azactam, Cayston
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    In countries and/or sites where aztreonam is available, adjunctive aztreonam may be initiated on Day 1 or during the first 3 days of treatment if the participant is determined or suspected to have an infection with a gram-negative aerobic pathogen.

    Arm title
    		 Antibiotic comparator drug
    Arm description
    		 IV and/or oral antibiotic comparator drug for 10 days. Participants with gram-negative wound infection may receive aztreonam (IV) and/or metronidazole (IV or oral).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Antibiotic comparator includes the following: Vancomycin, Linezolid, Clindamycin, Flucloxacillin, Cefazolin, Cephalexin.
    Investigational medicinal product code
    Other name
    Vancomycin: Vancocin, Firvanq, Lyphocin; Linezolid: Zyvox; Clindamycin: Cleocin; Cefazolin: Ancef, Kefzol; Cephalexin: Keflex, Zartan, Panixine, Biocef
    Pharmaceutical forms
    Infusion, Tablet, Capsule, Injection
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    Antibiotic comparator drug, IV and/or orally for 10 days.

    Investigational medicinal product name
    Metronidazole
    Investigational medicinal product code
    Other name
    Flagyl, Metro
    Pharmaceutical forms
    Injection, Tablet
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    Adjunctive metronidazole may be initiated on Day 1 or during the first 3 days of treatment if the participant is determined or suspected to have an infection with an anaerobic pathogen.

    Investigational medicinal product name
    Aztreonam
    Investigational medicinal product code
    Other name
    Azactam, Cayston
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    In countries and/or sites where aztreonam is available, adjunctive aztreonam may be initiated on Day 1 or during the first 3 days of treatment if the participant is determined or suspected to have an infection with an gram-negative aerobic pathogen.

    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: The assessor is blinded in this single-blind study.
    Number of subjects in period 1
    		Tedizolid Phosphate Antibiotic comparator drug
    Started
    91
    29
    Completed
    88
    28
    Not completed
    3
    1
         Consent withdrawn by subject
    1
    -
         Adverse event, non-fatal
    1
    -
         Gram-negative infection
    1
    -
         Reason not specified
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Tedizolid Phosphate
    Reporting group description
    		 Tedizolid Phosphate IV and/or oral 200 mg once per day for 6 days. Participants with gram-negative wound infection may receive aztreonam (IV) and/or metronidazole (IV or oral).

    Reporting group title
    Antibiotic comparator drug
    Reporting group description
    		 IV and/or oral antibiotic comparator drug for 10 days. Participants with gram-negative wound infection may receive aztreonam (IV) and/or metronidazole (IV or oral).

    Reporting group values
    		 Tedizolid Phosphate Antibiotic comparator drug Total
    Number of subjects
    		 91 29 120
    Age categorical
    Units: Subjects
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 91 29 120
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 14.4 ( 1.7 ) 14.4 ( 2.0 ) -
    Sex: Female, Male
    Units: Subjects
        Female
    		 33 12 45
        Male
    		 58 17 75
    Race (NIH/OMB)
    Units: Subjects
        Asian
    		 0 1 1
        Black or African American
    		 11 4 15
        White
    		 80 24 104

    End points

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    End points reporting groups
    Reporting group title
    Tedizolid Phosphate
    Reporting group description
    		 Tedizolid Phosphate IV and/or oral 200 mg once per day for 6 days. Participants with gram-negative wound infection may receive aztreonam (IV) and/or metronidazole (IV or oral).

    Reporting group title
    Antibiotic comparator drug
    Reporting group description
    		 IV and/or oral antibiotic comparator drug for 10 days. Participants with gram-negative wound infection may receive aztreonam (IV) and/or metronidazole (IV or oral).

    Primary: Number of Participants With Adverse Events on Tedizolid Phosphate and Comparator Drugs

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    End point title
    		 Number of Participants With Adverse Events on Tedizolid Phosphate and Comparator Drugs [1]
    End point description
    An adverse event (AE) refers to a treatment-emergent adverse event (TE-AE). A TE-AE is any AE that newly appeared, increased in frequency, or worsened in severity following initiation of study drug. The analysis population consisted of all randomized participants who received at least one dose of study drug.
    End point type
    Primary
    End point timeframe
    Up to 40 days (including 30-day follow-up)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned for this endpoint.
    End point values
    		 Tedizolid Phosphate Antibiotic comparator drug
    Number of subjects analysed
    91
    29
    Units: Participants
    13
    3
    No statistical analyses for this end point

    Secondary: Number of Participants with Investigator's Assessment Indicating Clinical Success at Test of Cure (TOC) Visit (Intent to Treat Analysis Set)

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    End point title
    		 Number of Participants with Investigator's Assessment Indicating Clinical Success at Test of Cure (TOC) Visit (Intent to Treat Analysis Set)
    End point description
    Investigator’s assessment of clinical success is defined as (1) resolution or near resolution of most disease-specific signs and symptoms, (2) absence or near resolution of regional or systemic signs of infection (lymphadenopathy, fever, >10% immature neutrophils, abnormal white blood cell count), if present at baseline, and (3) no new signs, symptoms, or complications attributable to the infection under study so no further antibiotic therapy is required for the treatment of the primary lesion. The analysis population consisted of all randomized participants.
    End point type
    Secondary
    End point timeframe
    TOC Visit: 18-25 days after first drug infusion
    End point values
    		 Tedizolid Phosphate Antibiotic comparator drug
    Number of subjects analysed
    91
    29
    Units: Participants
    88
    27
    Statistical analysis title
    		 Between group comparison
    Statistical analysis description
    The difference (Tedizolid minus Comparator group) in the clinical success rate and 95% confidence interval calculated using the unstratified method of Miettinen and Nurminen.
    Comparison groups
    Tedizolid Phosphate v Antibiotic comparator drug
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Difference in percentages
    Point estimate
    3.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.3
         upper limit
    		 13.5

    Secondary: Number of Participants with Investigator's Assessment Indicating Clinical Success at TOC Visit (Clinically Evaluable-Test of Cure [CE-TOC] Analysis Set)

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    End point title
    		 Number of Participants with Investigator's Assessment Indicating Clinical Success at TOC Visit (Clinically Evaluable-Test of Cure [CE-TOC] Analysis Set)
    End point description
    Investigator’s assessment of clinical success is defined as (1) resolution or near resolution of most disease-specific signs and symptoms, (2) absence or near resolution of regional or systemic signs of infection (lymphadenopathy, fever, >10% immature neutrophils, abnormal white blood cell count), if present at baseline, and (3) no new signs, symptoms, or complications attributable to the infection under study so no further antibiotic therapy is required for the treatment of the primary lesion. The analysis population consisted of all randomized participants who received a full dose of study treatment and completed TOC.
    End point type
    Secondary
    End point timeframe
    TOC Visit: 18-25 days after first drug infusionn
    End point values
    		 Tedizolid Phosphate Antibiotic comparator drug
    Number of subjects analysed
    87
    27
    Units: Participants
    87
    26
    Statistical analysis title
    		 Between group comparison
    Statistical analysis description
    The difference (Tedizolid minus Comparator group) in the clinical success rate and 95% confidence interval calculated using the unstratified method of Miettinen and Nurminen.
    Comparison groups
    Tedizolid Phosphate v Antibiotic comparator drug
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Difference in percentages
    Point estimate
    3.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.4
         upper limit
    		 10.8

    Secondary: Number of Participants with Early Clinical Responses Measured by Lesion Reduction

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    End point title
    		 Number of Participants with Early Clinical Responses Measured by Lesion Reduction
    End point description
    Early clinical response is defined as ≥20% reduction from baseline lesion area (defined as length multiplied by width of the erythema, edema, and/or induration [EEI]) at the 48-72 hour (hr) visit. The analysis population consisted of all randomized participants.
    End point type
    Secondary
    End point timeframe
    48-72 hr after first drug infusion
    End point values
    		 Tedizolid Phosphate Antibiotic comparator drug
    Number of subjects analysed
    91
    29
    Units: Participants
    84
    28
    Statistical analysis title
    		 Between group comparison
    Statistical analysis description
    The difference (Tedizolid minus Comparator group) in the clinical success rate and 95% confidence interval calculated using the unstratified method of Miettinen and Nurminen.
    Comparison groups
    Tedizolid Phosphate v Antibiotic comparator drug
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Difference in percentages
    Point estimate
    -4.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.9
         upper limit
    		 4.4

    Secondary: Number of Participants with Investigator's Assessment Indicating Clinical Success at at End of Therapy (EOT) Visit (Intent to Treat Analysis Set)

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    End point title
    		 Number of Participants with Investigator's Assessment Indicating Clinical Success at at End of Therapy (EOT) Visit (Intent to Treat Analysis Set)
    End point description
    Investigator’s assessment of clinical success is defined as (1) resolution or near resolution of most disease specific signs and symptoms, (2) absence or near resolution of regional or systemic signs of infection (lymphadenopathy, fever, >10% immature neutrophils, abnormal white blood cell count), if present at baseline, and (3) no new signs, symptoms, or complications attributable to the infection under study so no further antibiotic therapy is required for the treatment of the primary lesion. The analysis population consisted of all randomized participants.
    End point type
    Secondary
    End point timeframe
    EOT Visit: up to 13 days after first drug infusion
    End point values
    		 Tedizolid Phosphate Antibiotic comparator drug
    Number of subjects analysed
    91
    29
    Units: Participants
    88
    28
    Statistical analysis title
    		 Between group comparison
    Statistical analysis description
    The difference (Tedizolid minus Comparator group) in the clinical success rate and 95% confidence interval calculated using the unstratified method of Miettinen and Nurminen.
    Comparison groups
    Tedizolid Phosphate v Antibiotic comparator drug
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in percentages
    Point estimate
    0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.4
         upper limit
    		 7.7

    Secondary: Number of Participants with Investigator's Assessment Indicating Clinical Success at EOT Visit (Clinically Evaluable-End of Therapy [CE-EOT] Analysis Set)

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    End point title
    		 Number of Participants with Investigator's Assessment Indicating Clinical Success at EOT Visit (Clinically Evaluable-End of Therapy [CE-EOT] Analysis Set)
    End point description
    Investigator’s assessment of clinical success is defined as (1) resolution or near resolution of most disease specific signs and symptoms, (2) absence or near resolution of regional or systemic signs of infection (lymphadenopathy, fever, >10% immature neutrophils, abnormal white blood cell count), if present at baseline, and (3) no new signs, symptoms, or complications attributable to the infection under study so no further antibiotic therapy is required for the treatment of the primary lesion. The analysis population consisted of all randomized participants received a full dose of study treatment and completed EOT.
    End point type
    Secondary
    End point timeframe
    EOT Visit: up to 13 days after first drug infusion
    End point values
    		 Tedizolid Phosphate Antibiotic comparator drug
    Number of subjects analysed
    87
    27
    Units: Participants
    87
    27
    Statistical analysis title
    		 Between group comparison
    Statistical analysis description
    The difference (Tedizolid minus Comparator group) in the clinical success rate and 95% confidence interval calculated using the unstratified method of Miettinen and Nurminen.
    Comparison groups
    Tedizolid Phosphate v Antibiotic comparator drug
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in percnetages
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0

    Other pre-specified: Change from Baseline in Lesion Size

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    End point title
    		 Change from Baseline in Lesion Size
    End point description
    Lesion size is the area in cm^2 of erythema, edema or induration. A negative number corresponds to a decrease in lesion size. The analysis population consisted of all randomized participants who received a full dose of study treatment, had a baseline value and a TOC visit value (Days 18 to 25).
    End point type
    Other pre-specified
    End point timeframe
    Baseline and TOC visit (18 to 25 days after infusion)
    End point values
    		 Tedizolid Phosphate Antibiotic comparator drug
    Number of subjects analysed
    91
    29
    Units: cm^2
    arithmetic mean (standard deviation)
        Baseline
    135.44 ( 158.66 )
    83.22 ( 48.55 )
        TOC visit; n=88, n=28
    -134.27 ( 161.18 )
    -82.51 ( 49.94 )
    No statistical analyses for this end point

    Other pre-specified: Peak Plasma Concentration (Cmax) of Tedizolid

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    End point title
    		 Peak Plasma Concentration (Cmax) of Tedizolid
    End point description
    The Cmax of tedizolid in plasma after the last dose was estimated based on population pharmacokinetic analysis of observed pharmacokinetic data. Blood samples were collected for pharmacokinetic analysis at specific time points. The analysis population consisted of all randomized participants who received a dose of tedizolid phosphate. Pharmacokinetic analysis was not performed with participants receiving antibiotic comparator drug.
    End point type
    Other pre-specified
    End point timeframe
    Day 1 at 5-80 minutes (min) and 4-12 hrs post-infusion or 2 samples collected between 4-12 hrs after oral dose, at least 60 min apart; at 48-72 hrs: within 60 min prior to administration and 4-12 hrs after administration; and anytime between Day 7 and 9
    End point values
    		 Tedizolid Phosphate Antibiotic comparator drug
    Number of subjects analysed
    91
    29
    Units: µg/mL
        geometric mean (confidence interval 95%)
    3.13 (2.89 to 3.38)
    0 (0 to 0)
    No statistical analyses for this end point

    Other pre-specified: Area Under the Plasma Concentration Versus Time Curve Time 0 to 24 Hours (AUC0-24h) of Tedizolid

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    End point title
    		 Area Under the Plasma Concentration Versus Time Curve Time 0 to 24 Hours (AUC0-24h) of Tedizolid
    End point description
    AUC0-24h is a measure of the total tedizolid exposure in the plasma from the dose to 24 hours after last dose. AUC0-24h was estimated based on population pharmacokinetic analysis of observed pharmacokinetic data. Blood samples were collected for pharmacokinetic analysis at specific time points. The analysis population consisted of all randomized participants who received a dose of tedizolid phosphate. Pharmacokinetic analysis was not performed with participants receiving antibiotic comparator drug.
    End point type
    Other pre-specified
    End point timeframe
    Day 1 at 5-80 min and 4-12 hrs post-infusion or 2 samples collected between 4-12 hrs after oral dose, at least 60 min apart; at 48-72 hrs: within 60 min prior to administration and 4-12 hrs after administration; and anytime between Day 7 and 9
    End point values
    		 Tedizolid Phosphate Antibiotic comparator drug
    Number of subjects analysed
    91
    29
    Units: µg*h/mL
        geometric mean (confidence interval 95%)
    28.6 (26.6 to 30.8)
    0 (0 to 0)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Up to 40 days (including 30-day follow-up)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    Antibiotic comparator drug
    Reporting group description
    		 IV and/or oral antibiotic comparator drug for 10 days. Participants with gram-negative wound infection may receive aztreonam (IV) and/or metronidazole (IV or oral).

    Reporting group title
    Tedizolid Phosphate
    Reporting group description
    		 Tedizolid Phosphate IV and/or oral 200 mg once per day for 6 days. Participants with gram-negative wound infection may receive aztreonam (IV) and/or metronidazole (IV or oral).

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No non-serious adverse events exceeded the 5% threshold for any treatment group.
    Serious adverse events
    		 Antibiotic comparator drug Tedizolid Phosphate
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 91 (1.10%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Vascular disorders
    Venous Thrombosis Limb
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 91 (1.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 91 (1.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 91 (1.10%)
         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: 5%
    Non-serious adverse events
    		 Antibiotic comparator drug Tedizolid Phosphate
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 91 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Feb 2015
    Amendment #1: primary reason for this amendment was to revise the study design, schedule of assessments, discontinuation of treatment, study drug, administration, sample collection, reporting of adverse events, and protocol deviations.
    15 Apr 2016
    Amendment #2: primary reason for this amendment was to revise the secondary objectives, overall study design, schedule of assessments, exclusion criteria, discontinuation of treatment, concomitant therapy rules, study drug, administration, reporting of adverse events, and handling of missing data.
    27 Jun 2016
    Amendment #3: primary reason for this amendment was to revise "IV to oral” therapy to “IV and/or oral" therapy, the inclusion/exclusion criteria, and sample collection assessment.
    01 Feb 2017
    Amendment #4: primary reason for this amendment was to revise the study design, study drug, safety samples, exclusion criteria, and discontinuation of treatment.
    22 Jun 2017
    Amendment #5: primary reason for this amendment was to revise the exclusion criteria and concomitant medications.
    13 Jun 2018
    Amendment #6: primary reason for this amendment was to revise the overall study design and the number of participants.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    23 May 2016
    Global interruption was due to excursions in storage temperatures of the investigational product
    23 Jun 2016

    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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