Efficacy of Loperamide in Treating Patients for C. Difficile Colitis and Diarrheal Disease of Unknown Cause Associated With Antibiotic Therapy (loperamide)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by VA Medical Center, Houston.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
VA Medical Center, Houston
ClinicalTrials.gov Identifier:
NCT00591357
First received: December 31, 2007
Last updated: January 16, 2008
Last verified: December 2007

December 31, 2007
January 16, 2008
October 2007
December 2009   (final data collection date for primary outcome measure)
To determin symptomatic treatment of diarrhea with loperamide in antibiotic associated diarrhea [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00591357 on ClinicalTrials.gov Archive Site
To measure the safety and efficacy of loperamide in the control of antibiotic associated diarrhea in hospitalized patients [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Efficacy of Loperamide in Treating Patients for C. Difficile Colitis and Diarrheal Disease of Unknown Cause Associated With Antibiotic Therapy
Study of the Efficacy of Loperamide in Treating Patients for Clostridium Difficile Colitis and Diarrheal Disease of Unknown Cause Associated With Prior Antibiotic Therapy.

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Antibiotic Associated Diarrhea
  • Clostridium Difficile
  • Drug: loperamide
    4 mg PO initially and 2 mg after each water stoll not to exceed 10 mg qd
  • Drug: placebo
    4 mg PO initially and 2 mg after each water stoll not to exceed 10 mg qd
  • Active Comparator: A
    Loperamide
    Intervention: Drug: loperamide
  • Placebo Comparator: B
    Placebo
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
Not Provided
December 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Nancy D Logan, MA 504-988-7889 njarrar@bcm.edu
Contact: Hoonmo k Koo, MD 713-798-8918 koo@bcm.edu
United States
 
NCT00591357
H-21387, Clostridium difficile, Antibiotic associated diarrhea, loperamide
No
Daniel Musher, MD Principal Investigator, Michael E. DeBakey VAMC
VA Medical Center, Houston
Not Provided
Principal Investigator: Daniel M Musher, MD VA Medical Center, Houston
VA Medical Center, Houston
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP