Fidaxomicin Versus Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD) (MK-5119-018)

Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Status and phase: Completed; Phase 3

Conditions: Diarrhea; Clostridium Infections

Treatments: Drug: Matching Placebo to Fidaxomicin; Drug: Fidaxomicin; Drug: Vancomycin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00314951

101.1.C.003 (Other Identifier)

5119-018

Details and patient eligibility

About

This is a comparative study to investigate the safety and efficacy of fidaxomicin versus vancomycin in subjects with Clostridium difficile-Associated Diarrhea (CDAD).

Full description

The primary objective of this pivotal study is to investigate the safety and efficacy of fidaxomicin versus vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD). The cure rates at end of therapy and recurrence rates will be evaluated and compared.

Enrollment: 629 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males/females with CDAD
• Females must use adequate contraception
• Signed informed consent

Exclusion criteria

• Life-threatening CDAD
• Toxic megacolon
• Pregnant
• Concurrent use of diarrheal agents
• Participation in other trials

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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629 participants in 2 patient groups

fidaxomicin

Experimental group

Description:

Participants receiving fidaxomicin 200 mg capsules orally two times daily (every 12 hours \[q12h\] regimen) with intermittent matching placebo to fidaxomicin

Treatment:

Drug: Matching Placebo to Fidaxomicin

Drug: Fidaxomicin

Vancomycin

Active Comparator group

Description:

Participants receiving vancomycin 125 mg capsules orally four times daily (every 6 hours \[q6h\] regimen).

Treatment:

Drug: Vancomycin