International clinical study to compare cadazolid to vancomycin to treatCDAD

Phase 1

• Conditions: Clostridium difficile-associated diarrhea (CDAD); MedDRA version: 16.1Level: PTClassification code 10054236Term: Clostridium difficile infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2013-002528-17-IT
• Lead Sponsor: Actelion Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-09
• Last Update Posted: 19 February 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 640

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 liquid or unformed bowel movements (UBM) within 24 hours prior to randomization,
AND
Positive C. difficile toxin test on a stool sample produced 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 416
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 224

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.
- 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