Impact of Bismuth Subsalicylate on Antimicrobial Use Among Adult Diarrhea Outpatients--Pakistan

Study Overview
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Brief Summary
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The purpose of this study is to learn whether bismuth subsalicylate can reduce use of antibiotics among adults with diarrhea in Pakistan.

Official Title
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Randomized, Double-blind, Placebo-controlled Trial of the Impact of Bismuth Subsalicylate on Antimicrobial Use Among Adult Diarrhea Outpatients in Pakistan

Conditions
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Diarrhea

Intervention / Treatment
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* Drug: Bismuth subsalicylate
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Persons aged 15 - 65 years old Presenting with mild to moderate, non-bloody, acute diarrhea (≥3 loose stools/day for <3 days) to participating health care settings For whom the study physicians recommend antimicrobial treatment Exclusion Criteria: Is pregnant Requires hospitalization Has signs or symptoms of septicemia Has a primary complaint of another acute illness Has a serious chronic illness Has an allergy to aspirin Has been exposed to antimicrobial or antidiarrheal medications within 72 hours of enrollment Previously enrolled in study

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bismuth subsalicylate<br>Bismuth subsalicylate, 262 mg/chewable tablet, 2 tablets every hour as needed up to 16 tablets per 24 hours, for up to 48 hours. | Drug: Bismuth subsalicylate<br> <br> * Other names: Pepto-Bismol;|
| Placebo Comparator: Placebo<br>Placebo chewable tablets, 2 every hour as needed up to 16 tablets per 24 h, for up to 48 h. | Other: Placebo<br>* Chewable tablets identical to intervention tablets, but missing the bismuth subsalicylate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| use of antimicrobial medications |  | within 5 days of enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's perceived need for antibiotics |  | Within 48 h of enrollment | 
| additional care obtained for diarrhea | Use of antidiarrheal medications, visits to other health professionals for diarrhea or complications of diarrhea, or expenditures on consultations and treatments for diarrheal illness | within 48 h of enrollment | 
| Additional care obtained for diarrheal illness | Use of antidiarrheal medications, visits to other health professionals for diarrhea or complications of diarrhea, or expenditures on consultations and treatments for diarrheal illness | within 5 days of enrollment | 
| Disease severity and duration | Time to first formed stool Number of stools during first 48 h of observation Duration of abdominal pain Duration of nausea Time to resolution of illness (any of the following symptoms: diarrhea, nausea, vomiting, abdominal pain) Severity of all symptoms of illness | within 5 days of enrollment | 
| Patient experience with the study drug | i. Satisfaction with resolution of symptoms ii. Satisfaction with esthetics of study medication iii. Adverse effects | within 5 days of enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diarrhea, gastroenteritis, antimicrobial drug resistance, antimicrobial agents, Pakistan, ambulatory care, bismuth