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    Clinical Trial Results:
    A Phase 2/3, Randomized, Open-Label, Multi-center Study to Determine the Safety and Efficacy of Solithromycin in Adolescents (12 to 17 years of age, inclusive) and Children (≥2 months to <12 years of age) with Suspected or Confirmed Community-Acquired Bacterial Pneumonia

    Summary
    EudraCT number
    		 2014-004039-37
    Trial protocol
    		 Outside EU/EEA   GB   HU   ES  
    Global end of trial date
    07 Apr 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Nov 2018
    First version publication date
    14 Nov 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CE01-203
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02605122
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Cempra Pharmaceuticals Inc., a wholly owned subsidiary of Melinta Therapeutics, Inc.
    Sponsor organisation address
    6340 Quadrangle Drive, Suite 100, Chapel Hill, United States, 27517
    Public contact
    Regulatory Department, Chiltern International Ltd, regulatory.service@chiltern.com
    Scientific contact
    Regulatory Department, Chiltern International Ltd, regulatory.service@chiltern.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001581-PIP01-13
    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
    07 Apr 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    07 Apr 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Apr 2018
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Evaluate the safety and tolerability of solithromycin in adolescents and children with Community-Acquired Bacterial Pneumonia (CABP)
    Protection of trial subjects
    The study was conducted by investigators experienced in the treatment of pediatric subjects. The parent(s) or guardian(s) as well as the children were fully informed of all pertinent aspects of the clinical trial as well as the possibility to discontinue at any time. In addition to the consent form for the parent(s)/guardian(s), an assent form in child appropriate language was provided and explained to the child. The number of blood samples as well as the amount of blood drawn were adjusted according to age and weight.
    Background therapy
    		 -
    Evidence for comparator
    		 Multiple standard of care comparators were used per protocol for the treatment of CABP.
    Actual start date of recruitment
    06 Sep 2016
    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
    Spain: 1
    Country: Number of subjects enrolled
    Bulgaria: 27
    Country: Number of subjects enrolled
    Hungary: 23
    Country: Number of subjects enrolled
    United States: 30
    Country: Number of subjects enrolled
    Philippines: 16
    Worldwide total number of subjects
    97
    EEA total number of subjects
    51
    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)
    6
    Children (2-11 years)
    49
    Adolescents (12-17 years)
    42
    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
    		 Recruitment period from September 2016- March 2018. The study was terminated after 97 subjects were enrolled.

    Pre-assignment
    Screening details
    		 Subjects were randomized to either Solithromycin or an active comparator.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    A health care provider designated as a sub-investigator blinded to treatment allocation at the site documented clinical response at specified time points during the study.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Solithromycin
    Arm description
    		 Solithromycin for 5-7 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Solithromycin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, Powder for oral suspension, Powder for infusion
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    Capsules, up to 800 mg dose on Day 1 and up to 400 mg daily thereafter. IV, 8 mg/kg daily. Oral Suspension, 20 mg/kg on Day 1 and 10 mg/kg daily thereafter.

    Arm title
    		 Comparator
    Arm description
    		 Comparators were dosed according to age and were consistent with current recommendations for treatment of CABP in children per site standard of care.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ceftriaxone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Per site standard of care.

    Investigational medicinal product name
    Amoxicillin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Per site standard of care.

    Investigational medicinal product name
    Amoxicillin-Clavulanic acid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for oral suspension, Powder for infusion
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    Per site standard of care.

    Investigational medicinal product name
    Ampicillin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Per site standard of care.

    Investigational medicinal product name
    Azithromycin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for injection, Powder for oral suspension
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    Per site standard of care.

    Investigational medicinal product name
    Erythromycin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for infusion, Powder for oral suspension
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    Per site standard of care.

    Investigational medicinal product name
    Erythromycin lactobionate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for infusion, Powder for oral suspension
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    Per site standard of care.

    Number of subjects in period 1
    		Solithromycin Comparator
    Started
    73
    24
    Completed
    68
    22
    Not completed
    5
    2
         Consent withdrawn by subject
    4
    1
         Lost to follow-up
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Study
    Reporting group description
    		 Subjects who meet all inclusion/exclusion criteria and sign the informed consent/assent were enrolled. Subjects were randomized to receive solithromycin or a comparator antibiotic, administered IV and/or by mouth (PO) based on weight and age. Subjects were treated daily for 5 to 7 days with oral solithromycin and 5 to 7 days with IV or IV-to-oral solithromycin. Subjects were treated for 5 to 10 days with comparator antibiotics. Subjects received safety and efficacy assessments during and after treatment.

    Reporting group values
    		 Overall Study Total
    Number of subjects
    		 97 97
    Age categorical
    Units: Subjects
        Children (2-11 years)
    		 49 49
        Adolescents (12-17 years)
    		 42 42
        Infants and toddlers (2 month-23 months)
    		 6 6
    Gender categorical
    Units: Subjects
        Female
    		 40 40
        Male
    		 57 57

    End points

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    End points reporting groups
    Reporting group title
    Solithromycin
    Reporting group description
    		 Solithromycin for 5-7 days.

    Reporting group title
    Comparator
    Reporting group description
    		 Comparators were dosed according to age and were consistent with current recommendations for treatment of CABP in children per site standard of care.

    Primary: TEAEs through Day 16 and TESAEs through Day 28

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    End point title
    		 TEAEs through Day 16 and TESAEs through Day 28
    End point description
    Summary of subjects experiencing a TEAE through Day 16 visit and TESAEs through Day 28 visit (28 days ±4 days after randomization).
    End point type
    Primary
    End point timeframe
    Treatment through Day 28 (28 days +/- 4 days after randomization).
    End point values
    		 Solithromycin Comparator
    Number of subjects analysed
    70
    24
    Units: Subjects
        TEAE
    24
    7
        TESAE
    1
    1
    Statistical analysis title
    		 Summary of Subjects Experiencing a TEAE and TESAE
    Comparison groups
    Solithromycin v Comparator
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    Method
    		 Clopper-Pearson
    Parameter type
    		 Proportion experiencing TEAE or TESAE
    Point estimate
    34.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 23
         upper limit
    		 47
    Notes
    [1] - No statistical test was performed.

    Secondary: Clinical Improvement on Day 3-4

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    End point title
    		 Clinical Improvement on Day 3-4
    End point description
    Early Clinical Response was defined using the latest efficacy evaluation from Day 2 (if subject discharged prior to Day 2), Day 3, or Day 4, and was defined as improvement in at least 1 presenting sign/symptom of CABP with no deterioration in any signs/symptoms of CABP and no requirement for an additional antibiotic.
    End point type
    Secondary
    End point timeframe
    During treatment Day 3 or 4
    End point values
    		 Solithromycin Comparator
    Number of subjects analysed
    51
    15
    Units: Subjects
        Subjects achieving early Clinical Response
    34
    7
    Statistical analysis title
    		 Summary of Clinical Efficacy
    Comparison groups
    Solithromycin v Comparator
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 other [2]
    Method
    		 Clopper-Pearson
    Parameter type
    		 Achievement of Early Clinical Response
    Point estimate
    62.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 49
         upper limit
    		 74
    Notes
    [2] - No statistical test was performed.

    Secondary: Clinical Improvement on the last day of treatment (+ 48 hours)

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    End point title
    		 Clinical Improvement on the last day of treatment (+ 48 hours)
    End point description
    Clinical improvement was assessed using the latest efficacy evaluation conducted on last day of treatment (+ 48 hrs), and was defined identically to early clinical response.
    End point type
    Secondary
    End point timeframe
    Last day of treatment (+ 48 hours)
    End point values
    		 Solithromycin Comparator
    Number of subjects analysed
    62
    21
    Units: Subjects
        Subjects achieving Clinical Improvement
    40
    17
    Statistical analysis title
    		 Summary of Clinical Efficacy
    Comparison groups
    Solithromycin v Comparator
    Number of subjects included in analysis
    83
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    Method
    		 Clopper-Pearson
    Parameter type
    		 Achievement of Clinical Improvement
    Point estimate
    68.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 58
         upper limit
    		 78
    Notes
    [3] - No statistical test was performed.

    Secondary: Clinical cure during short-term follow-up at 16 days (+/- 4 days)

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    End point title
    		 Clinical cure during short-term follow-up at 16 days (+/- 4 days)
    End point description
    Clinical cure was assessed using the latest efficacy evaluation conducted on Day 16 (± 4 days) post-randomization, and was defined as resolution of all presenting signs/symptoms of CABP (excluding cough), no development of new signs/symptoms of CABP, and no requirement for an additional antibiotic.
    End point type
    Secondary
    End point timeframe
    Short-term follow-up at 16 days (+/- 4 days).
    End point values
    		 Solithromycin Comparator
    Number of subjects analysed
    60
    19
    Units: Subjects
        Subjects achieving Clinical Cure
    36
    13
    Statistical analysis title
    		 Summary of Clinical Efficacy
    Comparison groups
    Solithromycin v Comparator
    Number of subjects included in analysis
    79
    Analysis specification
    Pre-specified
    Analysis type
    		 other [4]
    Method
    		 Clopper-Pearson
    Parameter type
    		 Achievement of Clinical Cure
    Point estimate
    62
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 50
         upper limit
    		 73
    Notes
    [4] - No statistical test was performed.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    September 2016 to April 2018
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    Solithromycin
    Reporting group description
    		 -

    Reporting group title
    Comparator
    Reporting group description
    		 -

    Serious adverse events
    		 Solithromycin Comparator
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 70 (1.43%)
    1 / 24 (4.17%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia viral
         subjects affected / exposed
    0 / 70 (0.00%)
    1 / 24 (4.17%)
         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
    		 Solithromycin Comparator
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    24 / 70 (34.29%)
    7 / 24 (29.17%)
    Investigations
    Alanine Aminotransferase Increased
         subjects affected / exposed
    3 / 70 (4.29%)
    0 / 24 (0.00%)
         occurrences all number
    3
    0
    Hepatic Enzyme Increased
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Oxygen Saturation Decreased
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Transaminases increased
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Vascular disorders
    Phlebitis
         subjects affected / exposed
    5 / 70 (7.14%)
    0 / 24 (0.00%)
         occurrences all number
    5
    0
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    0 / 70 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 70 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Infusion Site Pain
         subjects affected / exposed
    6 / 70 (8.57%)
    0 / 24 (0.00%)
         occurrences all number
    6
    0
    Infusion Site Pruritus
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Infusion Site Urticaria
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Injection Site Reaction
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Oedema Peripheral
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 70 (1.43%)
    4 / 24 (16.67%)
         occurrences all number
    1
    4
    Abdominal Discomfort
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Vomiting
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Nasal Congestion
         subjects affected / exposed
    0 / 70 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Epistaxis
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Rhinitis Allergic
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Tachypnoea
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Rash
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Rash Erythematous
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Rash Maculo-Papular
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Urticaria
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 70 (1.43%)
    1 / 24 (4.17%)
         occurrences all number
    1
    1
    Pneumonia Viral
         subjects affected / exposed
    0 / 70 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Bacteraemia
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Infectious Pleural Effusion
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    0 / 70 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    Hyperglycaemia
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 Feb 2017
    Amendment incorporates additional safety laboratory evaluations along with new and updated dosing information for all 3 formulations of solithromycin.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    07 Apr 2018
    Notification of stop to recruitment and plan for early termination.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The study was discontinued early due to a company business decision. Study discontinuation was not related to safety or tolerability.
    For support, Contact us.
    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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