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

Phase 1

• Conditions: Clostridium difficile-associated diarrhea (CDAD); MedDRA version: 19.1Level: LLTClassification code 10012734Term: Diarrhea, Clostridium difficileSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 19.1Level: PTClassification code 10054236Term: Clostridium difficile infectionSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 19.1Level: LLTClassification code 10022661Term: Intestinal infection due to clostridium difficileSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 19.1Level: LLTClassification code 10012748Term: Diarrhoea, Clostridium difficileSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2015-004805-17-BE
• Lead Sponsor: Actelion Pharmaceuticals Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-11
• Last Update Posted: 20 August 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

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 < 18 years.
- Subject is diagnosed with CDAD
Are the trial subjects under 18? yes
Number of subjects for this age range: 200
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified