Study of Nitazoxanide in the Treatment of Clostridium Difficile-associated Disease

Phase 3 Terminated 50 enrolled Romark Laboratories L.C.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary objective of the study is to demonstrate non-inferiority of nitazoxanide compared to vancomycin in resolving symptoms of Clostridium difficile-associated disease (CDAD).

Timeline

Start: 2006-12
Primary completion: 2007-10
Completion: 2007-10

Publications

Musher DM, Logan N, Bressler AM, Johnson DP, Rossignol JF. Nitazoxanide versus vancomycin in Clostridium difficile infection: a randomized, double-blind study. Clin Infect Dis. 2009 Feb 15;48(4):e41-6. doi: 10.1086/596552.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nitazoxanide	Other / unclassified	500 mg	Oral
Comparator	Vancomycin	Other / unclassified	125 mg	Oral

Study of Nitazoxanide in the Treatment of Clostridium Difficile-associated Disease

Summary

Timeline

Publications

Drugs

Indications