International clinical study to compare cadazolid to vancomycin to treatCDAD

Phase 1

• Conditions: Clostridium difficile-associated diarrhea (CDAD); MedDRA version: 19.0Level: PTClassification code 10054236Term: Clostridium difficile infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2013-002508-15-CZ
• Lead Sponsor: Actelion Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12-16
• Last Update Posted: 3 July 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 630

Inclusion Criteria

- Signed Informed Consent.
- Male or female = 18 years of age. Females of childbearing potential must agree to use an adequate and reliable method of contraception.
- Subject with a diagnosis of mild-moderate or severe CDAD (first occurrence or first recurrence within 3 months) with:
Diarrhea: a change in bowel habits with > 3 unformed bowel movements (UBM) within 24 hours prior to randomization,
AND
Positive C. difficile GDH and toxin test on the same stool sampleproduced within 72 hours prior to randomization.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 411
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 219

Exclusion Criteria

- More than one previous episode of CDAD in the 3-month period prior to
randomization.
- Evidence of life-threatening or fulminant CDAD.
- Likelihood of death within 72 hours from any cause.
- History of inflammatory colitides, chronic abdominal pain, or chronic diarrhea or known positive diagnostic test for enteropathogens.
- Antimicrobial treatment active against CDAD administered for > 24 hours except for metronidazole treatment failures (MTF)
- Known hypersensitivity or contraindication to study drugs, oxazolidinones, or quinolones.
- Unable or unwilling to comply with all protocol requirements.

Study & Design

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