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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2014 by Centers for Disease Control and Prevention
Sponsor:
Collaborators:
Procter and Gamble
Health Oriented Preventive Education
Information provided by (Responsible Party):
Anna Bowen, Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT02047162
First received: January 24, 2014
Last updated: January 28, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention
Diarrhea
Drug: Bismuth subsalicylate
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Randomized, Double-blind, Placebo-controlled Trial of the Impact of Bismuth Subsalicylate on Antimicrobial Use Among Adult Diarrhea Outpatients in Pakistan

Resource links provided by NLM:


Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • use of antimicrobial medications [ Time Frame: within 5 days of enrollment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient's perceived need for antibiotics [ Time Frame: Within 48 h of enrollment ] [ Designated as safety issue: No ]
  • additional care obtained for diarrhea [ Time Frame: within 48 h of enrollment ] [ Designated as safety issue: No ]
    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 [ Time Frame: within 5 days of enrollment ] [ Designated as safety issue: No ]
    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 Frame: within 5 days of enrollment ] [ Designated as safety issue: No ]
    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 [ Time Frame: within 5 days of enrollment ] [ Designated as safety issue: No ]
    i. Satisfaction with resolution of symptoms ii. Satisfaction with esthetics of study medication iii. Adverse effects


Estimated Enrollment: 400
Study Start Date: April 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: Bismuth subsalicylate
Other Name: Pepto-Bismol
Placebo Comparator: Placebo
Placebo chewable tablets, 2 every hour as needed up to 16 tablets per 24 h, for up to 48 h.
Other: Placebo
Chewable tablets identical to intervention tablets, but missing the bismuth subsalicylate

  Eligibility

Ages Eligible for Study:   15 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02047162

Contacts
Contact: Mubina Agboatwalla, MD 923 332 13 1960 agboat@hope-ngo.com

Locations
Pakistan
HOPE Not yet recruiting
Karachi, Pakistan
Contact: Agboatwalla       agboat@hope-ngo.com   
Sponsors and Collaborators
Procter and Gamble
Health Oriented Preventive Education
Investigators
Principal Investigator: Anna Bowen, MD, MPH Centers for Disease Control and Prevention
  More Information

No publications provided

Responsible Party: Anna Bowen, Medical Epidemiologist, Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT02047162     History of Changes
Other Study ID Numbers: 6469
Study First Received: January 24, 2014
Last Updated: January 28, 2014
Health Authority: United States: Federal Government

Keywords provided by Centers for Disease Control and Prevention:
diarrhea
gastroenteritis
antimicrobial drug resistance
antimicrobial agents
Pakistan
ambulatory care
bismuth

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Anti-Infective Agents
Bismuth
Bismuth subsalicylate
Therapeutic Uses
Pharmacologic Actions
Antacids
Molecular Mechanisms of Pharmacological Action
Antidiarrheals
Gastrointestinal Agents

ClinicalTrials.gov processed this record on September 22, 2014