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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Antibiotic-Associated Diarrhea Clostridium Difficile

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A

Loperamide

Group Type ACTIVE_COMPARATOR

loperamide

Intervention Type DRUG

4 mg PO initially and 2 mg after each water stoll not to exceed 10 mg qd

B

Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

4 mg PO initially and 2 mg after each water stoll not to exceed 10 mg qd

Interventions

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loperamide

4 mg PO initially and 2 mg after each water stoll not to exceed 10 mg qd

Intervention Type DRUG

placebo

4 mg PO initially and 2 mg after each water stoll not to exceed 10 mg qd

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No