Clostridium InfectionsPhase 3NCT00384527
Study of Nitazoxanide in the Treatment of Clostridium Difficile-associated Disease
A Phase 3 study testing Nitazoxanide and Vancomycin in people with Clostridium Infections, run by Romark Laboratories L.C. at 10 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clostridium Infections
- What is being tested?
- Nitazoxanide and Vancomycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 10 sitesUnited States
- Study dates
- Dec 2006to Oct 2007
- Phase
- Phase 3
- 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.
- 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.
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- 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
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).
- 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].
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- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
John D. Dingell VAMC
Ann Arbor, Michigan, 48105
Atlanta Institute for Medical Research
Atlanta, Georgia, 30030
Wellstar Clinical Trials
Atlanta, Georgia, 30060
Bay Pines VAMC
Bay Pines, Florida, 33744
Michael E. Debakey VAMC
Houston, Texas, 77030
Richard L. Roudebush VAMC
Indianapolis, Indiana, 46202
Winthrop University Hospital
Mineola, New York, 11501
Oschner Clinic Foundation
New Orleans, Louisiana, 76121
Torrance Memorial Hospital
Torrance, California, 90505
Center for Digestive Health
Troy, Michigan, 48098
About this study
Official title: Multicenter, Double-blind Study of Nitazoxanide Compared to Vancomycin in the Treatment of Clostridium Difficile-associated Disease
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).
- Conditions
- Clostridium Infections
- Being tested
- Nitazoxanide, Vancomycin
- Keywords
- Clostridium difficile
- Medical subject headings
- Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NitazoxanideDrug
Also called Alinia
One nitazoxanide 500 mg tablet twice daily plus one vancomycin-placebo capsule four times daily for 10 days.
VancomycinDrug
Also called VANCOCIN
One vancomycin 125 mg capsule four times daily plus one nitazoxanide-placebo twice daily for 10 days.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Nitazoxanide |
| 2 | Active comparator | Not described Receives: Drug: Vancomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response (resolution of all symptoms of CDAD)
Measured: End of treatment (day 12-14 after beginning treatment)
Secondary outcomes (4)
Time from first dose to resolution of symptoms of CDAD
Measured: Any time after beginning treatment and must be sustained through end of treatment visit
Microbiological Recurrence
Measured: 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
Measured: End of treatment response sustained through study day 31.
Clinical Recurrence
Measured: Clinical response at the end of treatment with recurrent symptoms of CDAD prior to study day 31, but no C. difficile toxins detected.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2006 (estimated)
- Study startDec 2006
- Primary completionOct 2007
- Study completionOct 2007
Why it stopped: Study was terminated early due to slow recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Clostridium InfectionsStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Romark Laboratories L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Carol Kauffman, MD, Principal investigator, John D. Dingell VAMCAdam Bressler, MD, Principal investigator, Atlanta Institute for Medical ResearchWesley Bray, MD, Principal investigator, Wellstar Clinical TrialsJames Grendell, MD, Principal investigator, Winthrop University HospitalBradley Allen, MD, Principal investigator, Richard L. Roudebush VA Medical CenterPartha Nandi, MD, Principal investigator, Center for Digestive HealthDaniel Musher, MD, Principal investigator, Michael E. Debakey VAMCJulia Garcia-Diaz, MD, Principal investigator, Oschner Clinic Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00384527
- Sponsor's protocol ID
- RM01-3032
- Status last verified
- Oct 2008
- First submitted
- 5 Oct 2006
- Last updated
- 5 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Musher DM, Logan N, Bressler AM, Johnson DP, Rossignol JF. Nitazoxanide versus vancomycin in Clostridium difficile infection: a randomized, double-blind study. Clin Infect Dis. 2009 Feb 15;48(4):e41-6. doi: 10.1086/596552.
PubMed 19133801
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Double-blind Study of Nitazoxanide Compared to Vancomycin in the Treatment of Clostridium Difficile-associated Disease
- ClinicalTrials.gov ID
- NCT00384527
- Acronym / sponsor ID
- RM01-3032
- Conditions
- Clostridium Infections
- Keywords
- Clostridium difficile
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated early due to slow recruitment.
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Romark Laboratories L.C.Industry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 6 Oct 2006 (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 of the study is to demonstrate non-inferiority of nitazoxanide compared to vancomycin in resolving symptoms of Clostridium difficile-associated disease (CDAD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Nitazoxanide |
| 2 | Active comparator | Drug: Vancomycin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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:
- 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:
Key exclusion criteria (9 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).
- 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.
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 |
|---|---|---|
| NitazoxanideAlso: AliniaOne nitazoxanide 500 mg tablet twice daily plus one vancomycin-placebo capsule four times daily for 10 days. | Drug | 1 |
| VancomycinAlso: VANCOCINOne vancomycin 125 mg capsule four times daily plus one nitazoxanide-placebo twice daily for 10 days. | Drug | 2 |
Primary outcome
Clinical response (resolution of all symptoms of CDAD)
Time frame: End of treatment (day 12-14 after beginning treatment)
4 secondary outcomes
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
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.
Sustained clinical response
Time frame: End of treatment response sustained through study day 31.
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.
Results and safety
The study was stopped early (reason given: Study was terminated early due to slow recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2015.
- Derived from this study: PubMed 19133801Musher DM, Logan N, Bressler AM, Johnson DP, Rossignol JF. Nitazoxanide versus vancomycin in Clostridium difficile infection: a randomized, double-blind study. Clin Infect Dis. 2009 Feb 15;48(4):e41-6. doi: 10.1086/596552.
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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.
Carol Kauffman, MD principal investigator
John D. Dingell VAMC
Adam Bressler, MD principal investigator
Atlanta Institute for Medical Research
Wesley Bray, MD principal investigator
Wellstar Clinical Trials
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nitazoxanide and Vancomycin in people with Clostridium Infections, run by Romark Laboratories L.C. at 10 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 15 inclusion and 9 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: stopped early, as of the sponsor's last update on 5 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: Study was terminated early due to slow recruitment.). Results are not available in the source record.
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 of CDAD) (time frame: End of treatment (day 12-14 after beginning treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00384527, which also lists 1 linked publication.
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 5 May 2015.