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

This study is not yet open for participant recruitment.
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
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 April 15, 2014