NCT02047162

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 28, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

January 30, 2019

Status Verified

January 1, 2019

Enrollment Period

4 months

First QC Date

January 24, 2014

Last Update Submit

January 29, 2019

Conditions

Diarrhea

Keywords

diarrheagastroenteritisantimicrobial drug resistanceantimicrobial agentsPakistanambulatory carebismuth

Outcome Measures

Primary Outcomes (1)

  • use of antimicrobial medications

    within 5 days of enrollment

Secondary Outcomes (5)

  • Patient's perceived need for antibiotics

    Within 48 h of enrollment

  • additional care obtained for diarrhea

    within 48 h of enrollment

  • Additional care obtained for diarrheal illness

    within 5 days of enrollment

  • Disease severity and duration

    within 5 days of enrollment

  • Patient experience with the study drug

    within 5 days of enrollment

Study Arms (2)

Bismuth subsalicylate

EXPERIMENTAL

Bismuth subsalicylate, 262 mg/chewable tablet, 2 tablets every hour as needed up to 16 tablets per 24 hours, for up to 48 hours.

Drug: Bismuth subsalicylate

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Bismuth subsalicylateDRUG
Also known as: Pepto-Bismol
Bismuth subsalicylate
PlaceboOTHER

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

Placebo

Eligibility Criteria

Age15 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HOPE

Karachi, Pakistan

Location

Related Publications (1)

  • 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.

    PMID: 31418805DERIVED

MeSH Terms

Conditions

DiarrheaGastroenteritis

Interventions

bismuth subsalicylate

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Anna Bowen, MD, MPH

    Centers for Disease Control and Prevention

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Epidemiologist

Study Record Dates

First Submitted

January 24, 2014

First Posted

January 28, 2014

Study Start

May 1, 2014

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

January 30, 2019

Record last verified: 2019-01

Locations

PA(1)