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    Clinical Trial Results:
    A prospective, multicenter study to investigate the pharmacokinetics, safety, and efficacy of cadazolid versus vancomycin in pediatric subjects with Clostridium difficile-associated diarrhea.

    Summary
    EudraCT number
    		 2015-004805-17
    Trial protocol
    		 BE   HU   IT   ES  
    Global end of trial date
    17 Apr 2018

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

    Trial information

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    Trial identification
    Sponsor protocol code
    AC-061A303
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03105479
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Actelion Pharmaceuticals Ltd
    Sponsor organisation address
    Gewerbestrasse 16, Allschwil, Switzerland, 4123
    Public contact
    Clinical trial disclosure desk, Actelion Pharmaceuticals Ltd, clinical-trials-disclosure@its.jnj.com
    Scientific contact
    Clinical trial disclosure desk, Actelion Pharmaceuticals Ltd, clinical-trials-disclosure@its.jnj.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001108-PIP02-15
    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
    24 Aug 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Apr 2018
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Two parts were planned for this study: - The primary objective of Part A was to determine the cadazolid dose in children from birth to < 18 years of age by investigating the safety, efficacy, and the systemic and fecal pharmacokinetics (PK). - The primary objective of Part B was to assess the safety and efficacy of cadazolid in children from birth to < 18 years of age as compared with vancomycin.
    Protection of trial subjects
    The clinical trial was designed and conducted in accordance with the ICH Harmonized Tripartite Guidelines for GCP, with applicable local regulations, including the European Directive 2001/20/EC, the US CFR Title 21, and with the ethical principles laid down in the Declaration of Helsinki. The study was conducted by investigators experienced in the treatment of pediatric patients. In Part A, children were enrolled sequentially by groups of 3 subjects, starting with 3 adolescents aged between 12 and 18. After the completion of each group of 3, enrollment was temporarily put on hold and safety, pharmacokinetics and efficacy data reviewed by an Independent Data Monitoring Committee (IDMC) before enrollment of the next 3 subjects. Part B could start only when a dosing recommendation from the corresponding age cohort was available based on Part A.
    Background therapy
    		 -
    Evidence for comparator
    		 The comparator, vancomycin, to be used in part B, is approved in Europe and in the US for the treatment of mild–moderate CDAD
    Actual start date of recruitment
    13 Apr 2017
    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
    United States: 1
    Worldwide total number of subjects
    1
    EEA total number of subjects
    0
    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)
    1
    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
    		 Only one subject was enrolled in Part A. Part B was not conducted due to early study termination after the sponsor's decision to discontinue the clinical development program for cadazolid, taking into account the results of the two pivotal trials in adults.

    Pre-assignment
    Screening details
    		 Enrollment was to be staggered by age group starting with the older children (≥12 years). Enrollment in a younger age group was planned to initiate only following a review by the IDMC of the safety, pharmacokinetic and efficacy data from the first 3 children from the previous older age group.

    Period 1
    Period 1 title
    Overall study period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Cadazolid-Part A
    Arm description
    		 The anticipated starting doses were based on weight categories.
    Arm type
    		 Experimental

    Investigational medicinal product name
    cadazolid
    Investigational medicinal product code
    ACT-179811
    Other name
    Pharmaceutical forms
    Granules for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Administration twice daily for 10 days

    Number of subjects in period 1
    		Cadazolid-Part A
    Started
    1
    Completed
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall study period
    Reporting group description
    		 Part A

    Reporting group values
    		 Overall study period Total
    Number of subjects
    		 1 1
    Age categorical
    Units: Subjects
        Adolescents (12 years to < 18 years)
    		 1 1
        Children (2 years to< 12 years)
    		 0 0
        Infants and toddlers (3 months to < 2 years)
    		 0 0
    Gender categorical
    Units:
        Male
    		 0 0
        Female
    		 1 1

    End points

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    End points reporting groups
    Reporting group title
    Cadazolid-Part A
    Reporting group description
    		 The anticipated starting doses were based on weight categories.

    Primary: Maximal plasma concentration (Cmax) of cadazolid during part A

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    End point title
    		 Maximal plasma concentration (Cmax) of cadazolid during part A [1]
    End point description
    Blood samples were collected at different timepoints for the determination of cadazolid Cmax. Due to the premature study termination, cadazolid concentrations were obtained from only one subject and pharmacokinetic plasma profile was not analyzed because of lack of meaningful data.
    End point type
    Primary
    End point timeframe
    Day 10 (pre-dose, and 1h, 2h, 4h and 12h post-dose)
    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: Because the study was prematurely terminated with only 1 subject enrolled, no statistical analyses were performed.
    End point values
    		 Cadazolid-Part A
    Number of subjects analysed
    0 [2]
    Units: ng/mL
        geometric mean (confidence interval 95%)
    ( to )
    Notes
    [2] - No analysis performed due to early termination
    No statistical analyses for this end point

    Primary: Area under the plasma concentration curve (AUC) of cadazolid during part A

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    End point title
    		 Area under the plasma concentration curve (AUC) of cadazolid during part A [3]
    End point description
    Blood samples were collected at different timepoints for the determination of cadazolid AUC. Due to the premature study termination, cadazolid concentrations were obtained from only one subject and pharmacokinetic plasma profile was not analyzed because of lack of meaningful data.
    End point type
    Primary
    End point timeframe
    Day 10 (pre-dose, and 1h, 2h, 4h and 12h post-dose)
    Notes
    [3] - 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: Because only one subject was enrolled in the study and consequent lack of meaningful data, no statistical analyses were performed.
    End point values
    		 Cadazolid-Part A
    Number of subjects analysed
    0 [4]
    Units: ng*h/mL
        geometric mean (confidence interval 95%)
    ( to )
    Notes
    [4] - No analysis performed due to early termination
    No statistical analyses for this end point

    Primary: Time to reach Cmax of cadazolid during part A

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    End point title
    		 Time to reach Cmax of cadazolid during part A [5]
    End point description
    Blood samples were collected at different timepoints to determine the time when the maximal plasma concentration of cadazolid (Cmax) is reached. Due to the premature study termination, cadazolid concentrations were obtained from only one subject and median tmax could not be determined because of lack of meaningful data.
    End point type
    Primary
    End point timeframe
    Day 10 (pre-dose, and 1h, 2h, 4h and 12h post-dose)
    Notes
    [5] - 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: Because the study was prematurely terminated with only 1 subject enrolled, no statistical analyses were performed.
    End point values
    		 Cadazolid-Part A
    Number of subjects analysed
    0 [6]
    Units: hours
        median (full range (min-max))
    ( to )
    Notes
    [6] - No analysis performed due to early termination
    No statistical analyses for this end point

    Primary: Faecal concentrations of cadazolid during part A

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    End point title
    		 Faecal concentrations of cadazolid during part A [7]
    End point description
    A faecal sample was collected at the end-of-treatment visit. Due to premature termination, faecal sample was collected from only one subject, consequently further analyses (descriptive and statistical analyses) could not be conducted.
    End point type
    Primary
    End point timeframe
    Day 10
    Notes
    [7] - 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: Because the study was prematurely terminated with only 1 subject enrolled, no statistical analyses were performed.
    End point values
    		 Cadazolid-Part A
    Number of subjects analysed
    1
    Units: mcg/g
        number (not applicable)
    4520
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From study treatment initiation up to Day 37 (i.e., 27 Days after the end of treatment)
    Adverse event reporting additional description
    All adverse events (AE) which occurred at any time during the treatment period (10 days with cadazolid) and during the follow-up period (about 30 days) are reported. All AEs reported below occurred during the follow-up period.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Cadazolid-Part A
    Reporting group description
    		 One adolescent received cadazolid 250 mg twice daily during 10 days

    Serious adverse events
    		 Cadazolid-Part A
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 1 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Cadazolid-Part A
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 1 (100.00%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences all number
    1
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    sore throat
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Oct 2016
    The main reason for this amendment is to align the global protocol with the cadazolid Paediatric Investigation Plan (PIP) European Medicines Agency’s (EMA) decision and to align with FDA requirements.
    01 Mar 2017
    The main reason for this amendment is to address agreed changes in the responses to Voluntary Harmonisation Procedure (VHP) list of grounds for non-acceptance, dated 10 February 2017.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    02 Oct 2017
    Enrollment suspended during strategy review.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Results are not meaningful because only one patient was included in this study due to early termination
    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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