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

Centers for Disease Control and Prevention (CDC)

Status: Completed

Conditions: Diarrhea

Treatments: Drug: Bismuth subsalicylate; Other: Placebo

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; Industry

Identifiers

NCT02047162

6469

Details and patient eligibility

About

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

Enrollment: 400 patients

Sex: All

Ages: 15 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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400 participants in 2 patient groups, including a placebo group

Bismuth subsalicylate

Experimental group

Description:

Bismuth subsalicylate, 262 mg/chewable tablet, 2 tablets every hour as needed up to 16 tablets per 24 hours, for up to 48 hours.

Treatment:

Drug: Bismuth subsalicylate

Placebo

Placebo Comparator group

Description:

Placebo chewable tablets, 2 every hour as needed up to 16 tablets per 24 h, for up to 48 h.

Treatment:

Other: Placebo