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

Diarrhea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02047162
• Other study ID #: 6469
• Status: Completed
• Phase: N/A
• Start date: May 2014
• Est. completion date: September 2014

Study information

• Verified date: January 2019
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diarrhea

Intervention

Drug:
• Bismuth subsalicylate

Other:
• Placebo
Chewable tablets identical to intervention tablets, but missing the bismuth subsalicylate

Locations

Country	Name	City	State
Pakistan	HOPE	Karachi

Sponsors (3)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention	Health Oriented Preventive Education, Procter and Gamble

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	use of antimicrobial medications		within 5 days of enrollment
Secondary	Patient's perceived need for antibiotics		Within 48 h of enrollment
Secondary	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
Secondary	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
Secondary	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
Secondary	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