A clinical study to compare the effects of cadazolid with vancomycin in children with Clostridium difficile-associated diarrhea.

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

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-004805-17-IT

Enrollment

200

Registered

2017-05-16

Start date

Unknown

Completion date

Unknown

Last updated

2025-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clostridium difficile-associated diarrhea (CDAD) MedDRA version: 20.0 Level: LLT Classification code 10012734 Term: Diarrhea, Clostridium difficile System Organ Class: 10021881 - Infections and infestations MedDRA version: 20.0 Level: PT Classification code 10054236 Term: Clostridium difficile infection System Organ Class: 10021881 - Infections and infestations MedDRA version: 20.0 Level: LLT Classification code 10022661 Term: Intestinal infection due to clostridium difficile System Organ Cla

Interventions

Product Name: Cadazolid Product Code: ACT-179811 Pharmaceutical Form: Granules for oral suspension in sachet INN or Proposed INN: CADAZOLID Current Sponsor code: ACT-179811 Other descriptive name: CAD

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Parts A and B: - Signed informed consent by parents or legally authorized representatives (LAR) and assent by the child according to local requirements prior to initiation of any study-mandated procedure. - Male or female from birth to =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Parts A and B: - Positive Rotavirus test for subjects < 5 years. - Fulminant or life-threatening CDAD - More than one previous episode of CDAD in the 3 month period prior to enrolment/randomization. - Antimicrobial treatment active against CDAD administered within 24 h prior to screening except for metronidazole treatment failures (MTF). - Subjects with body weight < 3 kg. - Inflammatory bowel disease, chronic abdominal pain, or chronic diarrhea of any etiology. - Fecal microbiota transplant (FMT), immunoglobulin therapy, or any investigational drug to prevent or treat CDAD within 1 month period (or 5 half-lives in case of investigational drug, whichever is longer) prior to enrolment/randomization. - Monoclonal antibodies against C. difficile within 6 months prior to enrolment/randomization. - Previous vaccination against C. difficile. - Any circumstances or conditions, which, in the opinion of the investigator, may affect the subject’s full participation in the study, or compliance with the protocol.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of Part A is 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 is to assess the safety and efficacy of cadazolid in children from birth to < 18 years of age as compared with vancomycin. ;Secondary Objective: Secondary objectives of Part A are to assess the efficacy of cadazolid in terms of Clinical Cure, Sustained Clinical Cure, and Recurrence. Secondary objectives of Part B are to assess the efficacy of cadazolid in terms of Sustained Clinical Cure, Recurrence, time to Recurrence, and time to resolution of diarrhea (ROD) as compared to vancomycin.;Primary end point(s): Part A: Plasma concentrations of cadazolid Faecal concentrations of cadazolid Part B: Clinical cure;Timepoint(s) of evaluation of this end point: - At visit 3 (Part A) for plasma and faecal concentrations of cadazolid - End of treatment + 2 days (Part B) for Clinical cure	—

Measure

Time frame

Main Objective: The primary objective of Part A is 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 is to assess the safety and efficacy of cadazolid in children from birth to < 18 years of age as compared with vancomycin. ;Secondary Objective: Secondary objectives of Part A are to assess the efficacy of cadazolid in terms of Clinical Cure, Sustained Clinical Cure, and Recurrence. Secondary objectives of Part B are to assess the efficacy of cadazolid in terms of Sustained Clinical Cure, Recurrence, time to Recurrence, and time to resolution of diarrhea (ROD) as compared to vancomycin.;Primary end point(s): Part A: Plasma concentrations of cadazolid Faecal concentrations of cadazolid Part B: Clinical cure;Timepoint(s) of evaluation of this end point: - At visit 3 (Part A) for plasma and faecal concentrations of cadazolid - End of treatment + 2 days (Part B) for Clinical cure

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Secondary

Measure	Time frame
Secondary end point(s): Secondary efficacy endpoints: - Part A + Part B: Sustained Clinical Cure, Recurrence - Part A only: Clinical Cure - Part B only: Time to recurrence, Time to resolution of diarrhea Secondary safety endpoints (Part A and Part B): - Adverse events, serious adverse-events, adverse events leading to treatment discontinuation - Change from baseline and marked abnormalities in vital signs and laboratory tests Other secondary endpoints: Acceptability and palatability assessments.;Timepoint(s) of evaluation of this end point: - End of Treatment (EOT) + 2 days for Clinical Cure (Part A) - From last dose of study treatment to the time of onset of a new episode of diarrhea for Time to recurrence (Part B) - From the first study dose to the first day of resolution of diarrhea for Time to resolution of diarrhea (Part B) - EOT + 28 to 32 days for Sustained Cure and Recurrence (Part A + Part B) - Up to end of study or Up to EOT + 7 days for safety assessments - EOT for palatability and acceptability (Part A + Part B)	—

Measure

Time frame

Secondary end point(s): Secondary efficacy endpoints: - Part A + Part B: Sustained Clinical Cure, Recurrence - Part A only: Clinical Cure - Part B only: Time to recurrence, Time to resolution of diarrhea Secondary safety endpoints (Part A and Part B): - Adverse events, serious adverse-events, adverse events leading to treatment discontinuation - Change from baseline and marked abnormalities in vital signs and laboratory tests Other secondary endpoints: Acceptability and palatability assessments.;Timepoint(s) of evaluation of this end point: - End of Treatment (EOT) + 2 days for Clinical Cure (Part A) - From last dose of study treatment to the time of onset of a new episode of diarrhea for Time to recurrence (Part B) - From the first study dose to the first day of resolution of diarrhea for Time to resolution of diarrhea (Part B) - EOT + 28 to 32 days for Sustained Cure and Recurrence (Part A + Part B) - Up to end of study or Up to EOT + 7 days for safety assessments - EOT for palatability and acceptability (Part A + Part B)

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Countries

Belgium, Canada, Croatia, Czech Republic, Germany, Greece, Hungary, Italy, Poland, Romania, Spain, Turkey, United States

Contacts

Public ContactClinical trial disclosure desk

Actelion Pharmaceuticals Ltd

clinical-trials-disclosure@actelion.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026