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| Sponsor: | VA Medical Center, Houston |
|---|---|
| Information provided by: | VA Medical Center, Houston |
| ClinicalTrials.gov Identifier: | NCT00591357 |
Purpose
To determine whether symptomatic treatment of the diarrhea in CDAD reduces morbidity and mortality of this serious nosocomial infection in patients who have antibiotic-associated diarrhea. Both C. diff positive and negative patients will be included.
| Condition | Intervention | Phase |
|---|---|---|
|
Antibiotic Associated Diarrhea Clostridium Difficile |
Drug: loperamide Drug: placebo |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Study of the Efficacy of Loperamide in Treating Patients for Clostridium Difficile Colitis and Diarrheal Disease of Unknown Cause Associated With Prior Antibiotic Therapy. |
| Estimated Enrollment: | 120 |
| Study Start Date: | October 2007 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
A: Active Comparator
Loperamide
|
Drug: loperamide
4 mg PO initially and 2 mg after each water stoll not to exceed 10 mg qd
|
|
B: Placebo Comparator
Placebo
|
Drug: placebo
4 mg PO initially and 2 mg after each water stoll not to exceed 10 mg qd
|
Colitis due to Clostridium difficile has been increasingly recognized as a serious nosocomial problem. Recommended therapy is with metronidazole, 500 mg four times daily for 10 days. About 80% of patients respond to this therapy. However, the response may be be delayed, in which case debilitation due to diarrhea progresses. The 20% who do not respond tend to be sicker to start, and debilitation due to diarrhea is a severe problem. In reviewing the medical literature, we discovered that the earliest papers on C. difficile colitis emphasized symptomatic therapy with 'lomotil' (diphenoxylate with atropine).
Treatment to suppress the diarrhea fell out of favor in the late 1970's because of the theoretical consideration that it was better to expel than to retain the bacterial toxins. However, the patients who are affected by C. difficile colitis are increasingly elderly and debilitated, and suffer substantial morbidity from the diarrhea. We have shown that the 90-day associated mortality is >20%.
Loperamide is a standard treatment for diarrhea, and is available over the counter under the name, Imodium. Based on a few anecdotal reports, this drug is regarded as contraindicated in patients whose diarrheal disease is bacterial. But it is used widely, and generally without any diagnosis being established. We now propose to administer loperamide or placebo to patients with CDAD in order to determine whether the antidiarrheal drug reduces morbidity associated with the infection. We will monitor our patients closely both to observe potential benefits and/or adverse events.
In the addendum, we propose to include patients who have antibiotic-associated diarrheal disease that is not due to C. difficile. There are many patients who have antibiotic-associated diarrheal disease who test negative for C. difficile. We believe that these patient may benefit from loperamide treatment as well.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Nancy D Logan, MA | 504-988-7889 | njarrar@bcm.edu |
| Contact: Hoonmo k Koo, MD | 713-798-8918 | koo@bcm.edu |
| United States, Texas | |
| VAMC | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Nancy D Logan, MA 504-988-7889 njarrar@bcm.edu | |
| Contact: Hoonmo k Koo, MD 703-798-8918 koo@bcm.edu | |
| Principal Investigator: | Daniel M Musher, MD | VA Medical Center, Houston |
More Information
| Responsible Party: | Michael E. DeBakey VAMC ( Daniel Musher, MD Principal Investigator ) |
| Study ID Numbers: | H-21387, Clostridium difficile, Antibiotic associated diarrhea, loperamide |
| Study First Received: | December 31, 2007 |
| Last Updated: | January 16, 2008 |
| ClinicalTrials.gov Identifier: | NCT00591357 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Antibiotic associated diarrhea Clostridium difficile loperamide |
|
Anti-Infective Agents Diarrhea Signs and Symptoms, Digestive Gastrointestinal Diseases Colonic Diseases Gastrointestinal Agents Loperamide Intestinal Diseases |
Pharmacologic Actions Antidiarrheals Signs and Symptoms Anti-Bacterial Agents Digestive System Diseases Therapeutic Uses Gastroenteritis Colitis |
