A Phase 3 interventional study of Nitazoxanide in Clostridium Enterocolitis and Pseudomembranous Colitis, sponsored by Daniel M. Musher MD. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-12-15.
Sponsored by Daniel M. Musher MD · Phase 3, Interventional, and Treatment
The purpose of this study is for compassionate use of nitazoxanide in the treatment of diarrheal disease due to Clostridium difficile infection when the patient has failed previous treatment with metronidazole or vancomycin.
Clostridium difficile is the leading cause of nosocomial diarrheal disease associated with antibiotic therapy. This is a debilitating condition with substantial morbidity and a mortality that may be around 2-3%. There has been an enormous increase in this disease at the VA Medical Center during the past two years, just as has occurred at other hospitals throughout the United States.
Currently recommended therapy for this condition is metronidazole, given orally. About 15-20% of patients fail to respond to initial therapy with metronidazole, and another 20% relapse after treatment. Relapses may be treated with another course of metronidazole; about one-half will respond to this therapy. The failures are treated with oral vancomycin, but this drug also has a failure rate of 10-20%. There is, at present, no other accepted therapy (although some articles in the literature favor vancomycin with ingested bacteria from benign species). Furthermore, there is a strong risk to the emergence of resistant bacteria when hospitalized patients are treated with oral vancomycin.
Nitazoxanide is an FDA approved drug that is marketed in the U.S. and has been widely used throughout the world to treat parasitic diseases of the gastrointestinal tract; several million children have been treated with this drug during the past decade. Nitazoxanide has been approved as an antiprotozoal agent for oral administration in pediatric patients, ages 1 through 11, with diarrhea. The drug acts by interfering with anaerobic metabolic pathways, and it has been shown to have excellent in vitro activity against C. difficile. We hypothesized that this drug was both safe and effective as an alternative in patients who have diarrheal disease caused by C. difficile. The IRB approved a double-blind protocol to compare metronidazole with nitazoxanide, and we have treated a total of 16 patients so far under this protocol.
In our IRB-approved double blind study (by design, two thirds of the subjects have been randomized to the nitazoxanide), our patients have appeared to have a good response rate -- so good, in fact, that we think that nitazoxanide may be a better drug to treat this infection than either metronidazole or vancomycin.
43 studies on the registry are indexed under Enterocolitis, Pseudomembranous; 5 are open to participants now.
This study's enrollment of 22 is below the median of 100 across 29 interventional studies indexed under Enterocolitis, Pseudomembranous.
Browse Enterocolitis, Pseudomembranous studies →This is the only study on the registry with Daniel M. Musher MD as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
500 mg nitazoxanide bid given to patient
Drug: Nitazoxanide
500 mg bid
Also known as: alinia
Nitazoxanide
stopping of diarrhea
Time frame: 30 days
Chart review at the Houston VA for patients treated with Nitazoxanide who have failed previous therapy.
| Milestone | Nitazoxanide |
|---|---|
| Started | 27 |
| Completed | 22 |
| Not completed | 5 |
| Withdrew: Physician decision | 5 |
| Milestone | Nitazoxanide |
|---|---|
| Started | 27 |
| Completed | 22 |
| Not completed | 5 |
| Withdrew: Physician decision | 1 |
| Withdrew: Number is 0 | 1 |
| Withdrew: Physician decision | 1 |
| Withdrew: Physician decision | 1 |
| Withdrew: Physician decision | 1 |
stopping of diarrhea
| participants | Nitazoxanide |
|---|---|
| Nitazoxanide | 27 |
Collected over 30 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Nitazoxanide | — | 0/27 (0%) | 0/27 (0%) |
| Age, Categorical(Participants) | Nitazoxanide |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 27 |
| >=65 years | 0 |
| Age, Continuous(years) | Nitazoxanide |
|---|---|
| Mean | 27 ± 27 |
| Sex: Female, Male(Participants) | Nitazoxanide |
|---|---|
| Female | 0 |
| Male | 27 |
| Region of Enrollment(participants) | Nitazoxanide |
|---|---|
| United States | 27 |
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Nitazoxanide
Enterocolitis, Pseudomembranous →