The study successfully achieved its primary objective with an 89.5% response rate at study day 8 in Alinia-treated patients compared to 82.4% for metronidazole-treated patients.
142 patients were enrolled in the study and received either metronidazole 250mg four times per day for 10 days, or Alinia 500mg twice per day for either 7 or 10 days. Patients treated with 10 days of Alinia showed a lower recurrence rate (12.5%) than patients treated with metronidazole for 10 days (28.6%), although this difference in recurrence rate were not statistically significant.
“These are encouraging results,” said Dr Daniel Musher, head of infectious diseases at the Michael E DeBakey Veterans Affairs Medical Center and lead investigator for the study. “There are increasing reports of treatment failures and new toxigenic strains as well as continuing concerns over the selection of vancomycin-resistant bacteria. It is important that there be other options for treatment.”
Romark plans to initiate a final clinical trial early in 2006 designed to obtain data required for FDA approval to market Alinia for treating clostridium difficile-associated disease.
Clostridium difficile is a leading cause of diarrhea and colitis contracted in hospitals or long-term care facilities and associated with the use of antibiotics. The disease often affects elderly and debilitated patients and can be quite serious.