Efficacy, Safety and Tolerability of Cadazolid in Subjects With Clostridium Difficile Associated Diarrhea (CDAD)

Actelion Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Clostridium Difficile Infection

Treatments: Drug: Placebo-matching vancomycin; Drug: Vancomycin; Drug: Cadazolid; Drug: Placebo-matching cadazolid

Study type: Interventional

Funder types: Industry

Identifiers

NCT01222702

AC-061A201

Details and patient eligibility

About

Cadazolid is a new antibiotic developed for the treatment of Clostridiun difficile associated diarrhea (CDAD), also known as Clostridium Difficile Infection (CDI). The purpose of the study was to evaluate the efficacy and safety of different doses of cadazolid in order to find the dose of cadazolid to be used for further clinical development of the compound in subjects with CDAD.

Enrollment: 84 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Male or female
• At least 18 years of age
• With a diagnosis of Clostridium Difficile-associated diarrhea (CDAD): first occurrence or first recurrence.

Key Exclusion Criteria:

• Concurrent life threatening condition.
• Immuno-compromised subjects, concomittant immuno-suppresive treatment.
• Concomitant antimicrobial treatment for CDAD.
• Any circumstances or conditions, which, in the opinion of the investigator, would affect full participation of the subject in the study or compliance with the protocol

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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84 participants in 4 patient groups

Cadazolid 250 mg

Experimental group

Description:

Subjects received 250 mg of reconstituted cadazolid suspension twice daily and one placebo-matching vancomycin capsule four times daily for 10 days

Treatment:

Drug: Cadazolid

Drug: Placebo-matching vancomycin

Cadazolid 500 mg

Experimental group

Description:

Subjects received 500 mg of reconstituted cadazolid suspension twice daily and one placebo-matching vancomycin capsule four times daily for 10 days

Treatment:

Drug: Cadazolid

Drug: Placebo-matching vancomycin

Cadazolid 1000 mg

Experimental group

Description:

Subjects received 1000 mg of reconstituted cadazolid suspension twice daily and one placebo-matching vancomycin capsule four times daily for 10 days

Treatment:

Drug: Cadazolid

Drug: Placebo-matching vancomycin

Vancomycin 125 mg

Active Comparator group

Description:

Subjects received one vancomycin capsule (125 mg) four times daily and reconstituted placebo-matching cadazolid suspension twice daily for 10 days

Treatment:

Drug: Placebo-matching cadazolid

Drug: Vancomycin