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Efficacy of Loperamide for C. Difficile Colitis and Other Diarrheal Diseases Associated With Antibiotic Therapy (loperamide)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00591357
Recruitment Status : Suspended (Lack of personnel to complete trial)
First Posted : January 11, 2008
Last Update Posted : May 3, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Antibiotic-Associated Diarrhea Clostridium Difficile Drug: loperamide Drug: placebo Phase 4

Detailed Description:

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.
Study Start Date : October 2007
Primary Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Diarrhea
Drug Information available for: Loperamide
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: A
Loperamide
Drug: loperamide
4 mg PO initially and 2 mg after each water stoll not to exceed 10 mg qd
Placebo Comparator: B
Placebo
Drug: placebo
4 mg PO initially and 2 mg after each water stoll not to exceed 10 mg qd


Outcome Measures

Primary Outcome Measures :
  1. To determin symptomatic treatment of diarrhea with loperamide in antibiotic associated diarrhea [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. To measure the safety and efficacy of loperamide in the control of antibiotic associated diarrhea in hospitalized patients [ Time Frame: 2 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with diarrheal stools considered to be antibiotic associated

Exclusion Criteria:

  • Inability of sign consent
  • Patient with other known gastrointestinal disease
  • Patients receiving tube feeding or fecal incontinence prior to receiving antibiotics
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00591357


Locations
United States, Texas
VAMC
Houston, Texas, United States, 77030
Sponsors and Collaborators
VA Medical Center, Houston
Investigators
Principal Investigator: Daniel M Musher, MD VA Medical Center, Houston
More Information

Responsible Party: Daniel M. Musher MD, Principal Investigator, VA Medical Center, Houston
ClinicalTrials.gov Identifier: NCT00591357     History of Changes
Other Study ID Numbers: H-21387
Clostridium difficile
Antibiotic associated diarrhea
loperamide
First Posted: January 11, 2008    Key Record Dates
Last Update Posted: May 3, 2016
Last Verified: May 2016

Keywords provided by Daniel M. Musher MD, VA Medical Center, Houston:
Antibiotic associated diarrhea
Clostridium difficile
loperamide

Additional relevant MeSH terms:
Colitis
Diarrhea
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Anti-Bacterial Agents
Antibiotics, Antitubercular
Loperamide
Antidiarrheals
Anti-Infective Agents
Antitubercular Agents
Gastrointestinal Agents