EUCTR2015-004805-17-IT
Active, Not Recruiting
Phase 1
A prospective, multicenter study to investigate the pharmacokinetics, safety, and efficacy of cadazolid versus vancomycin in pediatric subjects with Clostridium difficile-associated diarrhea.
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Actelion Pharmaceuticals Ltd.
- Enrollment
- 200
- Status
- Active, Not Recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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 \< 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.
Outcomes
Primary Outcomes
Not specified
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