Efficacy and Safety of Cadazolid Versus Vancomycin in Subjects With Clostridium Difficile - Associated Diarrhea

Actelion Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Clostridium Difficile Infection

Treatments: Drug: Vancomycin-matching placebo; Drug: Cadazolid-matching placebo; Drug: Cadazolid; Drug: Vancomycin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01987895

AC-061A301

Details and patient eligibility

About

This clinical study is conducted to assess the efficacy of cadazolid compared to vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD).

Full description

Subjects selected to participate in the study are treated either with cadazolid or vancomycin for 10 days. At the end of treatment, clinical cure is assessed; subjects are then followed-up to assess any disease recurrence.

Enrollment: 632 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

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.
• Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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632 participants in 2 patient groups

Cadazolid

Experimental group

Description:

Subjects receive oral cadazolid 250 mg twice daily (bid) and oral vancomycin-matching placebo 4 times per day (qid) for 10 days

Treatment:

Drug: Cadazolid

Drug: Vancomycin-matching placebo

Vancomycin

Active Comparator group

Description:

Subjects receive oral vancomycin 125 mg qid and oral cadazolid-matching placebo bid for 10 days

Treatment:

Drug: Vancomycin

Drug: Cadazolid-matching placebo