Impact of Bismuth Subsalicylate on Antimicrobial Use Among Adult Diarrhea Outpatients--Pakistan
- Registration Number
- NCT02047162
- Lead Sponsor
- Centers for Disease Control and Prevention
- Brief Summary
The purpose of this study is to learn whether bismuth subsalicylate can reduce use of antibiotics among adults with diarrhea in Pakistan.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 400
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo chewable tablets, 2 every hour as needed up to 16 tablets per 24 h, for up to 48 h. Bismuth subsalicylate 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.
- Primary Outcome Measures
Name Time Method use of antimicrobial medications within 5 days of enrollment
- Secondary Outcome Measures
Name Time Method Additional care obtained for diarrheal illness within 5 days of enrollment Use of antidiarrheal medications, visits to other health professionals for diarrhea or complications of diarrhea, or expenditures on consultations and treatments for diarrheal illness
additional care obtained for diarrhea within 48 h of enrollment Use of antidiarrheal medications, visits to other health professionals for diarrhea or complications of diarrhea, or expenditures on consultations and treatments for diarrheal illness
Disease severity and duration within 5 days of enrollment 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
Patient experience with the study drug within 5 days of enrollment i. Satisfaction with resolution of symptoms ii. Satisfaction with esthetics of study medication iii. Adverse effects
Patient's perceived need for antibiotics Within 48 h of enrollment
Trial Locations
- Locations (1)
HOPE
🇵🇰Karachi, Pakistan