Clostridium Infections
Conditions
Keywords
Clostridium difficile
Brief 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).
Interventions
DRUGNitazoxanide
One nitazoxanide 500 mg tablet twice daily plus one vancomycin-placebo capsule four times daily for 10 days.
DRUGVancomycin
One vancomycin 125 mg capsule four times daily plus one nitazoxanide-placebo twice daily for 10 days.
Sponsors
Romark Laboratories L.C.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years. * Patients with new onset of disease evidenced by diarrhea (≥ 3 unformed stools within 24 hours), and one or more of the following symptoms of CDAD: * abdominal pain or cramps * peripheral leukocytosis * fever * C. difficile toxin A or B detected in a stool specimen obtained within 3 days before enrollment by enzyme immunoassay. * Patients willing to avoid the following medications during the study: * oral and intravenous metronidazole * oral vancomycin * anti-peristaltic drugs * opiates (patients on opiates may be included in the study if they were taking opiates prior to enrollment and the dose is not increased during the study) * Saccharomyces cerevisiae (baker's yeast) * Lactobacillus GG * cholestyramine * colestipol
Exclusion criteria
* Patients with other known causes of diarrhea or colitis (e.g., Shigella, Salmonella, Cryptosporidium parvum, Giardia lamblia, Entamoeba histolytica, inflammatory bowel disease, irritable bowel syndrome, advanced AIDS or chemotherapy for malignancy). * Patients that commonly have 3 or more stools per day and/or severe abdominal pain in the absence of CDAD. * Patients with severe lactose intolerance. * Patients with more than 1 recurrence of CDAD during the 6 months prior to enrollment. * Patients unable to take oral medications. * Use within 1 week of enrollment of any drug or therapy with anti-C. difficile activity such as oral or intravenous metronidazole and oral vancomycin. \[Patients that have taken up to 3 doses of metronidazole or vancomycin can be included in the study\]. * Females of child bearing age who are either pregnant, breast-feeding or not using birth control and are sexually active. * Patients who are either clinically unstable (e.g., fulminant disease patients with signs of toxic megacolon, imminent perforation, colectomy or death) or unlikely to live throughout the 31-day duration of the study due to underlying illness. * History of hypersensitivity to nitazoxanide or vancomycin or any active ingredient in the formulations.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical response (resolution of all symptoms of CDAD) | End of treatment (day 12-14 after beginning treatment) |
Secondary
| Measure | Time frame |
|---|---|
| Time from first dose to resolution of symptoms of CDAD | Any time after beginning treatment and must be sustained through end of treatment visit |
| Microbiological Recurrence | Clinical response at end of treatment visit with recurrence of symtpoms prior to study day 31 and C. difficile toxins detected in stool. |
| Sustained clinical response | End of treatment response sustained through study day 31. |
| Clinical Recurrence | Clinical response at the end of treatment with recurrent symptoms of CDAD prior to study day 31, but no C. difficile toxins detected. |
Countries
United States
Outcome results
None listed