Efficacy of Loperamide for C. Difficile Colitis and Other Diarrheal Diseases Associated With Antibiotic Therapy (loperamide)
Primary Purpose
Antibiotic-Associated Diarrhea, Clostridium Difficile
Status
Suspended
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
loperamide
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Antibiotic-Associated Diarrhea focused on measuring Antibiotic associated diarrhea, Clostridium difficile, loperamide
Eligibility 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
Sites / Locations
- VAMC
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
A
B
Arm Description
Loperamide
Placebo
Outcomes
Primary Outcome Measures
To determin symptomatic treatment of diarrhea with loperamide in antibiotic associated diarrhea
Secondary Outcome Measures
To measure the safety and efficacy of loperamide in the control of antibiotic associated diarrhea in hospitalized patients
Full Information
NCT ID
NCT00591357
First Posted
December 31, 2007
Last Updated
May 2, 2016
Sponsor
Michael E. DeBakey VA Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00591357
Brief Title
Efficacy of Loperamide for C. Difficile Colitis and Other Diarrheal Diseases Associated With Antibiotic Therapy
Acronym
loperamide
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 Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Suspended
Why Stopped
Lack of personnel to complete trial
Study Start Date
October 2007 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Michael E. DeBakey VA Medical Center
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Antibiotic-Associated Diarrhea, Clostridium Difficile
Keywords
Antibiotic associated diarrhea, Clostridium difficile, loperamide
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Arm Description
Loperamide
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
loperamide
Intervention Description
4 mg PO initially and 2 mg after each water stoll not to exceed 10 mg qd
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
4 mg PO initially and 2 mg after each water stoll not to exceed 10 mg qd
Primary Outcome Measure Information:
Title
To determin symptomatic treatment of diarrhea with loperamide in antibiotic associated diarrhea
Time Frame
2 years
Secondary Outcome Measure Information:
Title
To measure the safety and efficacy of loperamide in the control of antibiotic associated diarrhea in hospitalized patients
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel M Musher, MD
Organizational Affiliation
Michael E. DeBakey VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
VAMC
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Loperamide for C. Difficile Colitis and Other Diarrheal Diseases Associated With Antibiotic Therapy
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