A clinical research study in which a drug, ACT-179811, is being evaluated for its effects on diarrhea caused by a bacteria called Clostridium difficile

• Conditions: Clostridium difficile infection; MedDRA version: 14.0Level: LLTClassification code 10054236Term: Clostridium difficile infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2010-020941-29-DE
• Lead Sponsor: Actelion Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-08
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

Male or female.
At least 18 years old.
Subject with a diagnosis of CDI: first occurrence or first recurrence.
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 31
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 61

Exclusion Criteria

Concurrent life threatening condition.
Immuno-compromised subjects (i.e., WBC = 1,000 cells/mm3 or absolute neutrophils count = 500 cells/mm3), or Known HIV seropositive subjects unless on antiretoviral therapy with a CD4 count > 200 cells/mm3, or concomittant immuno-suppresive treatment (i.e., steroid treatment with prednisone > 30 mg daily or equivalent within 1 month prior to the screening visit).
Concomitant antimicrobial treatment for CDI.
Concomitant treatment with another investigational drug.

Study & Design

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