Clostridium DifficilePhase 2NCT00417872
Study of Nitazoxanide in the Treatment of Clostridium Difficile Colitis
A Phase 2 study testing Nitazoxanide and Metronidazole in people with Clostridium Difficile, run by Romark Laboratories L.C. at 7 sites in United States.
Trial summary
The primary objective is to demonstrate non-inferiority of nitazoxanide administered 500 mg b.i.d compared to metronidazole administered 250 mg q.i.d. in resolving symptoms of Clotridium difficile colitis after seven days of treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clostridium Difficile
- What is being tested?
- Nitazoxanide and Metronidazole
- How many people
- 114 participants
- Where
- 7 sitesUnited States
- Study dates
- Jan 2004to Sep 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- In-patients with new onset of colitis evidenced by diarrhea (≥3 unformed stools within 24 hours), with one or more of the following: abdominal pain or cramps; peripheral leukocytosis, otherwise unexplained; or fever, otherwise unexplained.
- C. difficile toxin A or B detected in a stool specimen obtained within 7 days before enrollment by enzyme immunoassay.
- Patients able to take oral medications.
- Patients willing to avoid the following medications during the study: oral and intravenous metronidazole, oral vancomycin, anti-peristaltic drugs, opiates, Saccharomyces cerevisiae (baker's yeast), Lactobacillus GC, cholestyramine or colestipol. [Patients on opiates may be included in the study as long as they were taking opiates prior to enrollment and the dose is not increased during the study].
- Patients willing to abstain from alcohol during the 10-day treatment duration and for two days following treatment.
Who cannot join
- 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).
- 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 2 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. A double barrier method, oral birth control pills administered for at least 2 monthly cycles prior to study drug administration, an IUD, or medroxyprogesterone acetate administered intramuscularly for a minimum of one month prior to study drug administration are acceptable methods of birth control for inclusion into the study. In addition, female patients of child-bearing potential should have a baseline pregnancy test and should agree to continue an acceptable method of birth control for the duration of the study (including follow-up).
- Patients taking phenytoin, celecoxib, and/or losartan. [Patients taking Coumadin® (warfarin) may be included as long the prothrombin time is monitored at least twice weekly during the first 2 weeks of the study and at least weekly thereafter].
- Patients with severe renal or hepatic impairment.
- Patients who are clinically unstable (e.g., patients with signs of toxic megacolon or imminent perforation).
- Serious systemic disorders incompatible with the study.
- History of hypersensitivity to metronidazole.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103
Remington-Davis, Inc., and Riverside Infection Consultants, Inc.
Columbus, Ohio, 43214
Houston Veterans Affairs Hospital
Houston, Texas, 77030
St. Luke's Episcopal Hospital
Houston, Texas, 77030
WellStar Infectious Diseases
Marietta, Georgia, 30060
Bayfront Medical Center and Edward White Hospital
St. Petersburg, Florida, 33713
The Reading Hospital and Medical Center
West Reading, Pennsylvania, 19611
About this study
Official title: Multicenter, Double Blind, Metronidazole Controlled, Dose Range Finding Study of Nitazoxanide in the Treatment of Clostridium Difficile Colitis
The primary objective is to demonstrate non-inferiority of nitazoxanide administered 500 mg b.i.d compared to metronidazole administered 250 mg q.i.d. in resolving symptoms of Clotridium difficile colitis after seven days of treatment. Secondary objectives are to provide information on the times from first dose to last unformed stool and resolution of symptoms of colitis, the sustained response rates for the different tratment groups and the effect of treatment on Clostridium difficile toxin enzyme immunoassay/culture results during hospitalization.
- Conditions
- Clostridium Difficile
- Being tested
- Nitazoxanide, Metronidazole
- Keywords
- Clostridium difficile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NitazoxanideDrug
MetronidazoleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response (resolution of all symptoms present at baseline) recorded on day 8
Secondary outcomes (4)
Time from first dose to passage of last unformed stool
Time from first dose to resolution of symptoms
Sustained clinical response (resolution of all symptoms present at baseline with no recurrence during follow-up)
C. difficile toxin enzyme immunoassay/culture results during hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2007 (estimated)
- Study startJan 2004
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clostridium DifficileStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 114 participants
Sponsor and investigators
- Lead sponsor
- Romark Laboratories L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ian M Baird, M.D., Principal investigator, Remington-Davis Inc., and Riverside Infection Consultants, Inc.Herbert L DuPont, M.D., Principal investigator, CHI St. Luke's Health, TexasArvind K Gupta, M.D., Principal investigator, Lehigh Valley HospitalRobert S Jones, D.O., Principal investigator, The Reading Hospital and Medical CenterArnold L Lentnek, M.D., Principal investigator, WellStar Infectious Diseases, Summit Surgical Specialists, and WellStar Kennestone HospitalDaniel Musher, M.D., Principal investigator, Houston Veterans Affairs HospitalFadi Saba, M.D., Principal investigator, Bayfront Medical Center and Edward White Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00417872
- Sponsor's protocol ID
- RM01-2015
- Status last verified
- Oct 2005
- First submitted
- 3 Jan 2007
- Last updated
- 4 Jan 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Double Blind, Metronidazole Controlled, Dose Range Finding Study of Nitazoxanide in the Treatment of Clostridium Difficile Colitis
- ClinicalTrials.gov ID
- NCT00417872
- Acronym / sponsor ID
- RM01-2015
- Conditions
- Clostridium Difficile
- Keywords
- Clostridium difficile
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants
- Lead sponsor
- Romark Laboratories L.C.Industry (pharma, biotech, devices)
- Study start
- Jan 2004
- Study completion
- Sep 2005
- First posted
- 4 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to demonstrate non-inferiority of nitazoxanide administered 500 mg b.i.d compared to metronidazole administered 250 mg q.i.d. in resolving symptoms of Clotridium difficile colitis after seven days of treatment. Secondary objectives are to provide information on the times from first dose to last unformed stool and resolution of symptoms of colitis, the sustained response rates for the different tratment groups and the effect of treatment on Clostridium difficile toxin enzyme immunoassay/culture results during hospitalization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years.
- In-patients with new onset of colitis evidenced by diarrhea (≥3 unformed stools within 24 hours), with one or more of the following: abdominal pain or cramps; peripheral leukocytosis, otherwise unexplained; or fever, otherwise unexplained.
- C. difficile toxin A or B detected in a stool specimen obtained within 7 days before enrollment by enzyme immunoassay.
- Patients able to take oral medications.
- Patients willing to avoid the following medications during the study: oral and intravenous metronidazole, oral vancomycin, anti-peristaltic drugs, opiates, Saccharomyces cerevisiae (baker's yeast), Lactobacillus GC, cholestyramine or colestipol. [Patients on opiates may be included in the study as long as they were taking opiates prior to enrollment and the dose is not increased during the study].
Key exclusion criteria (8 listed)
- 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).
- 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 2 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. A double barrier method, oral birth control pills administered for at least 2 monthly cycles prior to study drug administration, an IUD, or medroxyprogesterone acetate administered intramuscularly for a minimum of one month prior to study drug administration are acceptable methods of birth control for inclusion into the study. In addition, female patients of child-bearing potential should have a baseline pregnancy test and should agree to continue an acceptable method of birth control for the duration of the study (including follow-up).
- Patients taking phenytoin, celecoxib, and/or losartan. [Patients taking Coumadin® (warfarin) may be included as long the prothrombin time is monitored at least twice weekly during the first 2 weeks of the study and at least weekly thereafter].
- Patients with severe renal or hepatic impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nitazoxanide | Drug | – |
| Metronidazole | Drug | – |
Primary outcome
Clinical response (resolution of all symptoms present at baseline) recorded on day 8
4 secondary outcomes
Time from first dose to passage of last unformed stool
Time from first dose to resolution of symptoms
Sustained clinical response (resolution of all symptoms present at baseline with no recurrence during follow-up)
C. difficile toxin enzyme immunoassay/culture results during hospitalization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2007.
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Autologous Fecal Microbiota Transplantation (Auto-FMT) for Prophylaxis of Clostridium Difficile Infection in Recipients of Allogeneic Hematopoietic Stem Cell Transplantation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ian M Baird, M.D. principal investigator
Remington-Davis Inc., and Riverside Infection Consultants, Inc.
Herbert L DuPont, M.D. principal investigator
CHI St. Luke's Health, Texas
Arvind K Gupta, M.D. principal investigator
Lehigh Valley Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nitazoxanide and Metronidazole in people with Clostridium Difficile, run by Romark Laboratories L.C. at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical response (resolution of all symptoms present at baseline) recorded on day 8. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2007.