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

Primary Purpose

Diarrhea

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Bismuth subsalicylate
Placebo
Sponsored by
Centers for Disease Control and Prevention
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Diarrhea focused on measuring diarrhea, gastroenteritis, antimicrobial drug resistance, antimicrobial agents, Pakistan, ambulatory care, bismuth

Eligibility Criteria

15 Years - 65 Years (Child, Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • HOPE

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Bismuth subsalicylate

Placebo

Arm 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.

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

Outcomes

Primary Outcome Measures

use of antimicrobial medications

Secondary Outcome Measures

Patient's perceived need for antibiotics
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
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
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
Patient experience with the study drug
i. Satisfaction with resolution of symptoms ii. Satisfaction with esthetics of study medication iii. Adverse effects

Full Information

First Posted
January 24, 2014
Last Updated
January 29, 2019
Sponsor
Centers for Disease Control and Prevention
Collaborators
Procter and Gamble, Health Oriented Preventive Education
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1. Study Identification

Unique Protocol Identification Number
NCT02047162
Brief Title
Impact of Bismuth Subsalicylate on Antimicrobial Use Among Adult Diarrhea Outpatients--Pakistan
Official Title
Randomized, Double-blind, Placebo-controlled Trial of the Impact of Bismuth Subsalicylate on Antimicrobial Use Among Adult Diarrhea Outpatients in Pakistan
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centers for Disease Control and Prevention
Collaborators
Procter and Gamble, Health Oriented Preventive Education

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea
Keywords
diarrhea, gastroenteritis, antimicrobial drug resistance, antimicrobial agents, Pakistan, ambulatory care, bismuth

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bismuth subsalicylate
Arm Type
Experimental
Arm 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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo chewable tablets, 2 every hour as needed up to 16 tablets per 24 h, for up to 48 h.
Intervention Type
Drug
Intervention Name(s)
Bismuth subsalicylate
Other Intervention Name(s)
Pepto-Bismol
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Chewable tablets identical to intervention tablets, but missing the bismuth subsalicylate
Primary Outcome Measure Information:
Title
use of antimicrobial medications
Time Frame
within 5 days of enrollment
Secondary Outcome Measure Information:
Title
Patient's perceived need for antibiotics
Time Frame
Within 48 h of enrollment
Title
additional care obtained for diarrhea
Description
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
Title
Additional care obtained for diarrheal illness
Description
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
Title
Disease severity and duration
Description
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
Title
Patient experience with the study drug
Description
i. Satisfaction with resolution of symptoms ii. Satisfaction with esthetics of study medication iii. Adverse effects
Time Frame
within 5 days of enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Bowen, MD, MPH
Organizational Affiliation
Centers for Disease Control and Prevention
Official's Role
Principal Investigator
Facility Information:
Facility Name
HOPE
City
Karachi
Country
Pakistan

12. IPD Sharing Statement

Citations:
PubMed Identifier
31418805
Citation
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.
Results Reference
derived

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

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