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

N/ACompletedNCT02047162

Centers for Disease Control and Prevention400 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

QUADRUPLE

Enrollment

400

Conditions

Diarrhea

Interventions

Bismuth subsalicylateDRUG

PlaceboOTHER

Chewable tablets identical to intervention tablets, but missing the bismuth subsalicylate

Eligibility

Sex: ALLMin age: 15 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

HOPE

Karachi, Pakistan

Outcomes

Primary Outcomes

use of antimicrobial medications

Time frame: within 5 days of enrollment

Secondary Outcomes

Patient's perceived need for antibiotics

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: within 5 days of enrollment

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.