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    Clinical Trial Results:
    A Randomized, Double-Blind, Multi-Center Study to Evaluate the Efficacy and Safety of Intravenous to Oral Solithromycin (CEM-101) Compared to Intravenous to Oral Moxifloxacin in the Treatment of Adult Patients with Community-Acquired Bacterial Pneumonia

    Summary
    EudraCT number
    		 2013-003453-13
    Trial protocol
    		 HU   BG   LV   DE   ES   RO   SK   NL   SI  
    Global end of trial date
    07 Sep 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Nov 2016
    First version publication date
    12 Nov 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CE01-301
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01968733
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Cempra Pharmaceuticals, Inc.
    Sponsor organisation address
    6320 Quadrangle Drive, Suite 360, Chapel Hill, United States, NC 27517
    Public contact
    Clinical Trials Info, Cempra Pharmaceuticals, Inc., clinicaltrials@cempra.com
    Scientific contact
    Clinical Trials Info, Cempra Pharmaceuticals, Inc., clinicaltrials@cempra.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    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
    29 Apr 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    07 Sep 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Sep 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine noninferiority (NI) in the rate of Investigator assessment of clinical success of intravenous (IV) to oral solithromycin compared to IV to oral moxifloxacin at the Short-term Follow-Up Visit (SFU), 5 -10 days after the last dose of study drug in the Intent-To-Treat (ITT) and Clinically Evaluable (CE-SFU) populations for patients with a Pneumonia Outcomes Research Team (PORT) risk class of III/IV (ie, pneumonia severity index).
    Protection of trial subjects
    This study was conducted in compliance with the protocol and all regulatory requirements, in accordance with GCP, including International Conference on Harmonisation (ICH) guidelines, and in general conformity with the most recent version of the Declaration of Helsinki.
    Background therapy
    		 A single dose of a short-acting antibiotic (penicillins, cephalosporins [not ceftriaxone], tetracyclines, or trimethoprim-sulfamethoxazole) in the 7 days prior to enrolment was permitted (number of patient limited to 25% of the population).
    Evidence for comparator
    		 Moxifloxacin was chosen as the active comparator for multiple reasons. It has established efficacy in the treatment of CABP, with potent activity against key pathogens associated with CABP. Moxifloxacin is recommended empiric therapy for moderately severe CABP in the EU and USA. Additionally, moxifloxacin is available in IV and oral formulations, and thus is an appropriate comparator for both this study and Study CE01-300, the Phase 3 oral solithromycin CABP trial. It was also possible to define a common moxifloxacin regimen for all countries in which the study was conducted.
    Actual start date of recruitment
    14 Jan 2014
    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
    Poland: 51
    Country: Number of subjects enrolled
    Romania: 102
    Country: Number of subjects enrolled
    Slovakia: 2
    Country: Number of subjects enrolled
    Slovenia: 16
    Country: Number of subjects enrolled
    Spain: 17
    Country: Number of subjects enrolled
    Bulgaria: 80
    Country: Number of subjects enrolled
    Hungary: 29
    Country: Number of subjects enrolled
    Latvia: 17
    Country: Number of subjects enrolled
    Argentina: 5
    Country: Number of subjects enrolled
    Canada: 7
    Country: Number of subjects enrolled
    Chile: 2
    Country: Number of subjects enrolled
    Georgia: 63
    Country: Number of subjects enrolled
    Malaysia: 31
    Country: Number of subjects enrolled
    Peru: 9
    Country: Number of subjects enrolled
    Philippines: 79
    Country: Number of subjects enrolled
    Russian Federation: 40
    Country: Number of subjects enrolled
    Serbia: 88
    Country: Number of subjects enrolled
    South Africa: 40
    Country: Number of subjects enrolled
    Korea, Republic of: 10
    Country: Number of subjects enrolled
    Taiwan: 3
    Country: Number of subjects enrolled
    Ukraine: 76
    Country: Number of subjects enrolled
    United States: 96
    Worldwide total number of subjects
    863
    EEA total number of subjects
    314
    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)
    0
    Adults (18-64 years)
    478
    From 65 to 84 years
    355
    85 years and over
    30

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 863 patients were enrolled from 147 centres worldwide. For the MAA in EU, only PORT risk class of III/IV/V patients were studied and included 661 patients (ITT-EU); among them, 454 patients in Europe, 53 patients in North America, 12 patients in Latin America, 33 patients in South Africa and 109 patient in Asia Pacific.

    Pre-assignment
    Screening details
    		 Eligible patients were males or females ≥18 years of age with an acute onset or worsening of at least 3 of the following signs and symptoms of CABP: cough, production of purulent sputum, shortness of breath (dyspnea), chest pain. And at least 1 of the following: fever, hypothermia, presence of pulmonary rales and/or pulmonary consolidation.

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Assessor
    Blinding implementation details
    A double-dummy design was utilized, with solithromycin placebo capsules identical in appearance to solithromycin capsules and moxifloxacin placebo over-encapsulated tablets identical in appearance to moxifloxacin over-encapsulated tablets. After dosing with IV study drug was completed, an exact number of capsules needed to complete 7 days of dosing were provided in blister packs to patients who met the switch criteria.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Solithromycin (PORT III/IV/V)
    Arm description
    		 Solithromycin treatment group
    Arm type
    		 Experimental

    Investigational medicinal product name
    Solithromycin
    Investigational medicinal product code
    CEM-101
    Other name
    Pharmaceutical forms
    Powder for concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Day 1: Solithromycin 400 mg IV (250 mL over 60 [˗5/+20] minutes) followed by 400 mg IV daily until predefined oral switch criteria were met. First oral dose was 800 mg (4 x 200 mg capsules), followed by 400 mg (2 x 200 mg capsules) oral daily for the remainder of study (a total of 7 doses).

    Arm title
    		 Moxifloxacin (PORT III/IV/V)
    Arm description
    		 Moxifloxacin treatment group
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Moxifloxacin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Day 1: Moxifloxacin 400 mg IV daily (250 mL over 60 [˗5/+20] minutes), followed by 400 mg IV daily until predefined oral switch criteria (clinical improvement) were met, followed by 400 mg (1×400 mg capsule) oral moxifloxacin daily for a total of 7 doses.

    Number of subjects in period 1 [1]
    		Solithromycin (PORT III/IV/V) Moxifloxacin (PORT III/IV/V)
    Started
    328
    333
    Completed
    308
    318
    Not completed
    20
    15
         Adverse event, serious fatal
    5
    6
         Consent withdrawn by subject
    11
    7
         Adverse event, non-fatal
    2
    -
         randomised in error
    -
    2
         clinical failure
    2
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The reporting groups refer to PORT III/IV/V patients (EU analysis).

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Solithromycin (PORT III/IV/V)
    Reporting group description
    		 Solithromycin treatment group

    Reporting group title
    Moxifloxacin (PORT III/IV/V)
    Reporting group description
    		 Moxifloxacin treatment group

    Reporting group values
    		 Solithromycin (PORT III/IV/V) Moxifloxacin (PORT III/IV/V) Total
    Number of subjects
    		 328 333 661
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 152 151 303
        From 65-84 years
    		 161 169 330
        85 years and over
    		 15 13 28
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 64.2 ± 14.1 64.3 ± 13.6 -
    Gender categorical
    Units: Subjects
        Female
    		 156 142 298
        Male
    		 172 191 363
    PORT risk class
    Units: Subjects
        Port III
    		 196 204 400
        Port IV
    		 130 125 255
        Port V
    		 2 4 6

    End points

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    End points reporting groups
    Reporting group title
    Solithromycin (PORT III/IV/V)
    Reporting group description
    		 Solithromycin treatment group

    Reporting group title
    Moxifloxacin (PORT III/IV/V)
    Reporting group description
    		 Moxifloxacin treatment group

    Subject analysis set title
    Solithromycin -ITT Set (PORT III/IV/V)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All randomized patients with PORT III/IV/V regardless of whether or not the patient received study drug. A patient is considered randomized when the Investigator or Investigator's designee receives the IWRS-generated randomisation number.

    Subject analysis set title
    Moxifloxacin - ITT Set (PORT III/IV/V)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All randomized patients with PORT III/IV/V regardless of whether or not the patient received study drug. A patient is considered randomized when the Investigator or Investigator's designee receives the IWRS-generated randomisation number.

    Subject analysis set title
    Solithromycin - Clinically Evaluable Set (PORT III/IV/V)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All patients in the ITT population who also met the criteria listed in the SAP, among them: met key inclusion criteria, did not meet the exclusion criteria, completed the TOC Visit 5-10 days after the last dose of study drug, received ≥2 doses of study drug during the first 48 hours if the patient was a clinical failure, received ≥3 doses of study drug during the first 72 hours if the patient was a clinical success, did not receive another systemic antibacterial from the first dose of study drug through EOT (End of treatment) or through TOC with likely or documented activity against confirmed or potential CABP pathogens, received the correct study drug based on randomization assignment.

    Subject analysis set title
    Moxifloxacin - Clinically evaluable Set (PORT III/IV/V)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All patients in the ITT population who also met the criteria listed in the SAP, among them: met key inclusion criteria, did not meet the exclusion criteria, completed the TOC Visit 5-10 days after the last dose of study drug, received ≥2 doses of study drug during the first 48 hours if the patient was a clinical failure, received ≥3 doses of study drug during the first 72 hours if the patient was a clinical success, did not receive another systemic antibacterial from the first dose of study drug through EOT (End of treatment) or through TOC with likely or documented activity against confirmed or potential CABP pathogens, received the correct study drug based on randomization assignment.

    Primary: Clinical response-ITT at TOC: non-inferiority hypothesis

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    End point title
    		 Clinical response-ITT at TOC: non-inferiority hypothesis
    End point description
    Proportion of patients with clinical success of CABP symptoms. Clinical response rate at the TOC visit (or SFU visit) for the ITT Population is a co-primary endpoint of the study. Clinical response (Investigator assessment) is classified as success, failure, or indeterminate according to the definitions in the SAP.
    End point type
    Primary
    End point timeframe
    At Test of Cure (TOC), i.e. 5-10 days after last dose of study drug.
    End point values
    		 Solithromycin (PORT III/IV/V) Moxifloxacin (PORT III/IV/V)
    Number of subjects analysed
    328
    333
    Units: number of patients
        success
    281
    293
        failure
    38
    30
        indeterminate
    9
    10
    Statistical analysis title
    		 Non-inferiority analysis (success)-ITT
    Statistical analysis description
    H0: Difference (Solithromycin treatment group minus Moxifloxacin treatment group) of clinical success rates ≤ -10%
    Comparison groups
    Solithromycin (PORT III/IV/V) v Moxifloxacin (PORT III/IV/V)
    Number of subjects included in analysis
    661
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    		 non-inferiority test
    Parameter type
    		 Difference of clinical success rates
    Point estimate
    -2.32
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.8
         upper limit
    		 2.7
    Notes
    [1] - A non-inferiority margin of 10% was used.

    Primary: Clinical response - CE at TOC: non-inferiority hypothesis

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    End point title
    		 Clinical response - CE at TOC: non-inferiority hypothesis
    End point description
    Proportion of patients with clinical success of CABP symptoms at TOC for the Clinically Evaluable (CE) Population. This is a co-primary endpoint of the study. Clinical response (Investigator assessment) is classified as success, failure, or indeterminate according to the definitions in the SAP.
    End point type
    Primary
    End point timeframe
    At TOC, i.e. 5-10 days after the last dose of study drug.
    End point values
    		 Solithromycin (PORT III/IV/V) Moxifloxacin (PORT III/IV/V)
    Number of subjects analysed
    292 [2]
    300 [3]
    Units: number of patients
        success
    257
    276
        failure
    35
    24
        indeterminate
    0
    0
    Notes
    [2] - Solithromycin- Modified Clinically Evaluable Population (PORT III/IV/V)
    [3] - Moxifloxacin - Modified Clinically Evaluable Population (PORT III/IV/V)
    Statistical analysis title
    		 Non-inferiority hypotesis test (success) - CE
    Statistical analysis description
    H0: Differences (solithromycin minus Moxifloxacin treatment group) of clinical success rate ≤ -10%.
    Comparison groups
    Solithromycin (PORT III/IV/V) v Moxifloxacin (PORT III/IV/V)
    Number of subjects included in analysis
    592
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [4]
    Method
    Parameter type
    		 Difference in clinical success rates
    Point estimate
    -3.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.2
         upper limit
    		 1.2
    Notes
    [4] - A non-inferiority margin of 10% was used.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first study drug administration to late follow-up (Day 28-35 after first dose of study drug).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Solithromycin - safety population (PORT III/IV/V)
    Reporting group description
    		 -

    Reporting group title
    Moxifloxacin- safety population (PORT III/IV/V)
    Reporting group description
    		 -

    Reporting group title
    Solithromycin-safety population (All PORT)
    Reporting group description
    		 All patients

    Reporting group title
    Moxifloxacin-safety population (All PORT)
    Reporting group description
    		 Allpatients

    Serious adverse events
    		 Solithromycin - safety population (PORT III/IV/V) Moxifloxacin- safety population (PORT III/IV/V) Solithromycin-safety population (All PORT) Moxifloxacin-safety population (All PORT)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    25 / 327 (7.65%)
    20 / 331 (6.04%)
    30 / 432 (6.94%)
    23 / 426 (5.40%)
         number of deaths (all causes)
    5
    6
    5
    7
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute leukaemia
         subjects affected / exposed
    0 / 327 (0.00%)
    1 / 331 (0.30%)
    0 / 432 (0.00%)
    1 / 426 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Adrenal gland cancer
         subjects affected / exposed
    0 / 327 (0.00%)
    1 / 331 (0.30%)
    0 / 432 (0.00%)
    1 / 426 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Lung adenocarcinoma
         subjects affected / exposed
    0 / 327 (0.00%)
    1 / 331 (0.30%)
    0 / 432 (0.00%)
    1 / 426 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung adenocarcinoma metastatic
         subjects affected / exposed
    0 / 327 (0.00%)
    1 / 331 (0.30%)
    0 / 432 (0.00%)
    1 / 426 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small cell lung cancer
         subjects affected / exposed
    0 / 327 (0.00%)
    1 / 331 (0.30%)
    0 / 432 (0.00%)
    1 / 426 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    0 / 327 (0.00%)
    1 / 331 (0.30%)
    0 / 432 (0.00%)
    1 / 426 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    1 / 327 (0.31%)
    1 / 331 (0.30%)
    1 / 432 (0.23%)
    1 / 426 (0.23%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertensive crisis
         subjects affected / exposed
    1 / 327 (0.31%)
    0 / 331 (0.00%)
    1 / 432 (0.23%)
    0 / 426 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombophlebitis
         subjects affected / exposed
    0 / 327 (0.00%)
    0 / 331 (0.00%)
    0 / 432 (0.00%)
    1 / 426 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    0 / 327 (0.00%)
    1 / 331 (0.30%)
    0 / 432 (0.00%)
    1 / 426 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    1 / 327 (0.31%)
    0 / 331 (0.00%)
    1 / 432 (0.23%)
    0 / 426 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    0 / 327 (0.00%)
    1 / 331 (0.30%)
    0 / 432 (0.00%)
    1 / 426 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    2 / 327 (0.61%)
    0 / 331 (0.00%)
    2 / 432 (0.46%)
    1 / 426 (0.23%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 1
    Cardiac failure
         subjects affected / exposed
    1 / 327 (0.31%)
    1 / 331 (0.30%)
    1 / 432 (0.23%)
    1 / 426 (0.23%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    0 / 327 (0.00%)
    1 / 331 (0.30%)
    0 / 432 (0.00%)
    1 / 426 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Cardiovascular insufficiency
         subjects affected / exposed
    0 / 327 (0.00%)
    1 / 331 (0.30%)
    0 / 432 (0.00%)
    1 / 426 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    2 / 327 (0.61%)
    1 / 331 (0.30%)
    2 / 432 (0.46%)
    1 / 426 (0.23%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    0 / 2
    0 / 1
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 327 (0.31%)
    0 / 331 (0.00%)
    1 / 432 (0.23%)
    0 / 426 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    1 / 327 (0.31%)
    1 / 331 (0.30%)
    1 / 432 (0.23%)
    1 / 426 (0.23%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastric haemorrhage
         subjects affected / exposed
    0 / 327 (0.00%)
    1 / 331 (0.30%)
    0 / 432 (0.00%)
    1 / 426 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Large intestine perforation
         subjects affected / exposed
    1 / 327 (0.31%)
    0 / 331 (0.00%)
    1 / 432 (0.23%)
    0 / 426 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    1 / 327 (0.31%)
    0 / 331 (0.00%)
    1 / 432 (0.23%)
    0 / 426 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    1 / 327 (0.31%)
    4 / 331 (1.21%)
    1 / 432 (0.23%)
    4 / 426 (0.94%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 6
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Aspiration
         subjects affected / exposed
    0 / 327 (0.00%)
    1 / 331 (0.30%)
    0 / 432 (0.00%)
    1 / 426 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Asthmatic crisis
         subjects affected / exposed
    1 / 327 (0.31%)
    0 / 331 (0.00%)
    1 / 432 (0.23%)
    0 / 426 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 327 (0.31%)
    2 / 331 (0.60%)
    1 / 432 (0.23%)
    2 / 426 (0.47%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Haemoptysis
         subjects affected / exposed
    1 / 327 (0.31%)
    0 / 331 (0.00%)
    1 / 432 (0.23%)
    0 / 426 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    2 / 327 (0.61%)
    0 / 331 (0.00%)
    2 / 432 (0.46%)
    0 / 426 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    1 / 327 (0.31%)
    0 / 331 (0.00%)
    1 / 432 (0.23%)
    0 / 426 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 327 (0.00%)
    1 / 331 (0.30%)
    0 / 432 (0.00%)
    1 / 426 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    1 / 327 (0.31%)
    0 / 331 (0.00%)
    1 / 432 (0.23%)
    0 / 426 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    0 / 327 (0.00%)
    1 / 331 (0.30%)
    1 / 432 (0.23%)
    1 / 426 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Upper airway obstruction
         subjects affected / exposed
    1 / 327 (0.31%)
    0 / 331 (0.00%)
    1 / 432 (0.23%)
    0 / 426 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Skin and subcutaneous tissue disorders
    Urticaria
         subjects affected / exposed
    0 / 327 (0.00%)
    0 / 331 (0.00%)
    1 / 432 (0.23%)
    0 / 426 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Hydronephrosis
         subjects affected / exposed
    1 / 327 (0.31%)
    0 / 331 (0.00%)
    1 / 432 (0.23%)
    0 / 426 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    0 / 327 (0.00%)
    1 / 331 (0.30%)
    0 / 432 (0.00%)
    1 / 426 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 327 (0.00%)
    1 / 331 (0.30%)
    0 / 432 (0.00%)
    1 / 426 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Empyema
         subjects affected / exposed
    1 / 327 (0.31%)
    0 / 331 (0.00%)
    1 / 432 (0.23%)
    1 / 426 (0.23%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocarditis bacterial
         subjects affected / exposed
    1 / 327 (0.31%)
    0 / 331 (0.00%)
    1 / 432 (0.23%)
    0 / 426 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 327 (0.00%)
    1 / 331 (0.30%)
    0 / 432 (0.00%)
    1 / 426 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lobar Pneumonia
         subjects affected / exposed
    1 / 327 (0.31%)
    0 / 331 (0.00%)
    1 / 432 (0.23%)
    0 / 426 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung abscess
         subjects affected / exposed
    1 / 327 (0.31%)
    0 / 331 (0.00%)
    1 / 432 (0.23%)
    0 / 426 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    3 / 327 (0.92%)
    3 / 331 (0.91%)
    7 / 432 (1.62%)
    3 / 426 (0.70%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
    0 / 7
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary tuberculosis
         subjects affected / exposed
    1 / 327 (0.31%)
    0 / 331 (0.00%)
    1 / 432 (0.23%)
    0 / 426 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    1 / 327 (0.31%)
    0 / 331 (0.00%)
    1 / 432 (0.23%)
    0 / 426 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection viral
         subjects affected / exposed
    0 / 327 (0.00%)
    1 / 331 (0.30%)
    0 / 432 (0.00%)
    1 / 426 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    sepsis
         subjects affected / exposed
    0 / 327 (0.00%)
    1 / 331 (0.30%)
    0 / 432 (0.00%)
    1 / 426 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Septic shock
         subjects affected / exposed
    1 / 327 (0.31%)
    1 / 331 (0.30%)
    1 / 432 (0.23%)
    1 / 426 (0.23%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Solithromycin - safety population (PORT III/IV/V) Moxifloxacin- safety population (PORT III/IV/V) Solithromycin-safety population (All PORT) Moxifloxacin-safety population (All PORT)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    139 / 327 (42.51%)
    104 / 331 (31.42%)
    193 / 432 (44.68%)
    125 / 426 (29.34%)
    Injury, poisoning and procedural complications
    Infusion related reaction
         subjects affected / exposed
    19 / 327 (5.81%)
    1 / 331 (0.30%)
    28 / 432 (6.48%)
    1 / 426 (0.23%)
         occurrences all number
    38
    1
    57
    1
    Vascular disorders
    hypertension
         subjects affected / exposed
    5 / 327 (1.53%)
    7 / 331 (2.11%)
    5 / 432 (1.16%)
    9 / 426 (2.11%)
         occurrences all number
    5
    7
    5
    9
    Nervous system disorders
    dizziness
         subjects affected / exposed
    7 / 327 (2.14%)
    2 / 331 (0.60%)
    11 / 432 (2.55%)
    5 / 426 (1.17%)
         occurrences all number
    8
    2
    12
    6
    headache
         subjects affected / exposed
    7 / 327 (2.14%)
    16 / 331 (4.83%)
    15 / 432 (3.47%)
    18 / 426 (4.23%)
         occurrences all number
    8
    16
    17
    19
    General disorders and administration site conditions
    Infusion site pain
         subjects affected / exposed
    33 / 327 (10.09%)
    6 / 331 (1.81%)
    45 / 432 (10.42%)
    6 / 426 (1.41%)
         occurrences all number
    63
    6
    87
    6
    Infusion site phlebitis
         subjects affected / exposed
    32 / 327 (9.79%)
    4 / 331 (1.21%)
    43 / 432 (9.95%)
    4 / 426 (0.94%)
         occurrences all number
    37
    4
    50
    4
    Infusion site erythema
         subjects affected / exposed
    12 / 327 (3.67%)
    2 / 331 (0.60%)
    19 / 432 (4.40%)
    2 / 426 (0.47%)
         occurrences all number
    16
    6
    27
    6
    Infusion site thrombosis
         subjects affected / exposed
    9 / 327 (2.75%)
    6 / 331 (1.81%)
    9 / 432 (2.08%)
    7 / 426 (1.64%)
         occurrences all number
    13
    10
    13
    12
    Infusion site paraesthesia
         subjects affected / exposed
    8 / 327 (2.45%)
    0 / 331 (0.00%)
    9 / 432 (2.08%)
    0 / 426 (0.00%)
         occurrences all number
    8
    0
    9
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    11 / 327 (3.36%)
    22 / 331 (6.65%)
    19 / 432 (4.40%)
    25 / 426 (5.87%)
         occurrences all number
    11
    23
    19
    26
    Nausea
         subjects affected / exposed
    8 / 327 (2.45%)
    3 / 331 (0.91%)
    14 / 432 (3.24%)
    7 / 426 (1.64%)
         occurrences all number
    8
    3
    14
    7
    Psychiatric disorders
    insomnia
         subjects affected / exposed
    7 / 327 (2.14%)
    3 / 331 (0.91%)
    9 / 432 (2.08%)
    5 / 426 (1.17%)
         occurrences all number
    7
    3
    9
    5
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    10 / 327 (3.06%)
    7 / 331 (2.11%)
    11 / 432 (2.55%)
    9 / 426 (2.11%)
         occurrences all number
    10
    7
    11
    9

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/27448679
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