Bangladesh Secondary Transmission Handwashing Protocol
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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) |
- 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 ]
- 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 |
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| Bangladesh | |
| Pavani K. Ram | |
| Kishoreganj, Bangladesh | |
| 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 May 19, 2013