Impact of Bismuth Subsalicylate on Antimicrobial Use Among Adult Diarrhea Outpatients--Pakistan
NCT ID: NCT02047162
Last Updated: 2019-01-30
Study Results
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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COMPLETED
NA
400 participants
INTERVENTIONAL
2014-05-31
2014-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
QUADRUPLE
Study Groups
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Bismuth subsalicylate
Bismuth subsalicylate, 262 mg/chewable tablet, 2 tablets every hour as needed up to 16 tablets per 24 hours, for up to 48 hours.
Bismuth subsalicylate
Placebo
Placebo chewable tablets, 2 every hour as needed up to 16 tablets per 24 h, for up to 48 h.
Placebo
Chewable tablets identical to intervention tablets, but missing the bismuth subsalicylate
Interventions
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Bismuth subsalicylate
Placebo
Chewable tablets identical to intervention tablets, but missing the bismuth subsalicylate
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
15 Years
65 Years
ALL
Yes
Sponsors
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Procter and Gamble
INDUSTRY
Health Oriented Preventive Education
OTHER
Centers for Disease Control and Prevention
FED
Responsible Party
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Anna Bowen
Medical Epidemiologist
Principal Investigators
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Anna Bowen, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Centers for Disease Control and Prevention
Locations
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HOPE
Karachi, , Pakistan
Countries
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References
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Bowen A, Agboatwalla M, Pitz A, Salahuddin S, Brum J, Plikaytis B. Effect of Bismuth Subsalicylate vs Placebo on Use of Antibiotics Among Adult Outpatients With Diarrhea in Pakistan: A Randomized Clinical Trial. JAMA Netw Open. 2019 Aug 2;2(8):e199441. doi: 10.1001/jamanetworkopen.2019.9441.
Other Identifiers
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6469
Identifier Type: -
Identifier Source: org_study_id
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