Bangladesh Secondary Transmission Handwashing Protocol

This study has been completed.
Sponsor:
Collaborator:
State University of New York at Buffalo
Information provided by:
International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier:
NCT00880659
First received: April 11, 2009
Last updated: December 29, 2010
Last verified: May 2010
  Purpose

The next influenza pandemic is expected to spread rapidly in resource-poor settings. Influenza viruses spread from human-to-human via large respiratory droplets. Transmission via large-particle respiratory droplets is believed to be mediated by close contact between infected and susceptible persons or contact with droplet-contaminated fomites. Close contact between infected and susceptible persons may consist of skin-to-skin contact (e.g., via hands) or inhalation of respiratory droplets (e.g., due to talking, coughing, or sneezing by the infected person). Airborne transmission, which is expected to result in transmission over long distances (>1 meter) and which would be mediated by ventilation, is believed to be uncommon. Therefore, the greatest risk of transmission from personal contact comes from those people who are closest to an index case, such as contacts living in the same household. There are, to date, no published estimates of the secondary attack ratio of influenza among household contacts of index case-patients in low-income countries. Moreover, the investigators do not have data on the risk factors for secondary transmission of influenza from index case-patients to their household contacts. There is some data for the benefits of promoting handwashing with soap on the risk of all-cause acute respiratory illness among children < 15 years old in a resource-poor setting in Pakistan. But, the investigators do not have evidence that promoting handwashing with soap will acutely reduce the risk of secondary transmission. Therefore, the investigators propose to conduct a study in rural Bangladesh to assess the following:

  • The secondary attack ratio of influenza among household contacts of an index case-patient with influenza
  • The risk factors for secondary transmission of influenza from an index case-patient to household contacts
  • The impact of promoting handwashing with soap on the risk of secondary transmission of influenza from an index case-patient to household contacts
  • The impact of handwashing promotion on handwashing behavior six months after intervention
  • The impact of handwashing promotion on the prevalence of respiratory infections, diarrhea and influenza

Condition Intervention Phase
Human Influenza
Behavioral: Soap
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prevention of Secondary Transmission of Human Influenza by Promoting Handwashing With Soap: The Bangladesh Interruption of Secondary Transmission of Influenza Study (BISTIS)

Resource links provided by NLM:


Further study details as provided by International Centre for Diarrhoeal Disease Research, Bangladesh:

Primary Outcome Measures:
  • To test the efficacy of a handwashing promotion intervention for prevention of intrahousehold transmission of influenza virus in a rural setting in Bangladesh [ Time Frame: 17 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To measure the secondary attack ratio of influenza among household contacts of influenza-infected persons in a rural setting in Bangladesh influenza-infected persons in a rural setting in Bangladesh [ Time Frame: 17 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 6600
Study Start Date: June 2009
Study Completion Date: December 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Promotion of handwashing with soap and maintenance of a fully stocked handwashing station.
Behavioral: Soap
Promotion of handwashing with soap
No Intervention: 2
Practice of routine handwashing among the household members

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Persons ≥ 5 years old: Influenza-like illness (ILI), defined as history of fever and either cough or sore throat with fever onset within the previous 24 hours
  • Persons < 5 years old: any child with acute fever with onset within the previous 24 hours
  • Return to home within 24 hours of presentation to Upazilla Health Complex, Jahurul Islam Medical College Hospital or the local pharmacies; i.e., the index case cannot be admitted for treatment. If admitted, the patient would not be eligible.
  • No fever in any bari resident during the 7 days preceding the patient's presentation to hospital (see definition below)
  • At least two persons (in addition to the index case-patient) who intend to reside in the bari during the subsequent 20 days
  • Residence within 30 minutes travel time (one-way) from the Upazilla Health Complex or Jahurul Islam Medical College Hospital or the local pharmacy.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00880659

Locations
Bangladesh
Pavani K. Ram
Kishoreganj, Bangladesh
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
State University of New York at Buffalo
Investigators
Principal Investigator: Eduardo Azziz-Baumgartner, MD, MPH International Centre for Diarrhoeal Disease Research, Bangladesh
  More Information

No publications provided

Responsible Party: Pavani K. Ram, Department of Social and Preventive Medicine
ClinicalTrials.gov Identifier: NCT00880659     History of Changes
Other Study ID Numbers: 2009-004
Study First Received: April 11, 2009
Last Updated: December 29, 2010
Health Authority: Bangladesh: Ethical Review Committee

Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
Influenza
secondary transmission
handwashing

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 24, 2014