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

Primary Purpose

Clostridium Infections

Status

Terminated

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Nitazoxanide

Vancomycin

About this trial

This is an interventional treatment trial for Clostridium Infections focused on measuring Clostridium difficile

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Clinical response (resolution of all symptoms of CDAD)

Secondary Outcome Measures

Time from first dose to resolution of symptoms of CDAD

Microbiological Recurrence

Sustained clinical response

Clinical Recurrence

Full Information

NCT ID

NCT00384527

First Posted

October 5, 2006

Last Updated

May 4, 2015

Sponsor

Romark Laboratories L.C.

1. Study Identification

Unique Protocol Identification Number

NCT00384527

Brief Title

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

Official Title

Multicenter, Double-blind Study of Nitazoxanide Compared to Vancomycin in the Treatment of Clostridium Difficile-associated Disease

Study Type

Interventional

2. Study Status

Record Verification Date

October 2008

Overall Recruitment Status

Terminated

Why Stopped

Study was terminated early due to slow recruitment.

Study Start Date

December 2006 (undefined)

Primary Completion Date

October 2007 (Actual)

Study Completion Date

October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Romark Laboratories L.C.

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Clostridium Infections

Keywords

Clostridium difficile

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Nitazoxanide

Other Intervention Name(s)

Alinia

Intervention Description

One nitazoxanide 500 mg tablet twice daily plus one vancomycin-placebo capsule four times daily for 10 days.

Intervention Type

Drug

Intervention Name(s)

Vancomycin

Other Intervention Name(s)

VANCOCIN

Intervention Description

One vancomycin 125 mg capsule four times daily plus one nitazoxanide-placebo twice daily for 10 days.

Primary Outcome Measure Information:

Title

Clinical response (resolution of all symptoms of CDAD)

Time Frame

End of treatment (day 12-14 after beginning treatment)

Secondary Outcome Measure Information:

Title

Time from first dose to resolution of symptoms of CDAD

Time Frame

Any time after beginning treatment and must be sustained through end of treatment visit

Title

Microbiological Recurrence

Time Frame

Clinical response at end of treatment visit with recurrence of symtpoms prior to study day 31 and C. difficile toxins detected in stool.

Title

Sustained clinical response

Time Frame

End of treatment response sustained through study day 31.

Title

Clinical Recurrence

Time Frame

Clinical response at the end of treatment with recurrent symptoms of CDAD prior to study day 31, but no C. difficile toxins detected.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials: