Bangladesh Secondary Transmission Handwashing Protocol

NCT00880659 | Completed Phase 2 DMC

• 1 other identifier: 2009-004
• Study Type: interventional
• Target: 6,600
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Human Influenza

Keywords

Influenza; secondary transmission; handwashing

Outcome Measures

Primary Outcomes (1)

• To test the efficacy of a handwashing promotion intervention for prevention of intrahousehold transmission of influenza virus in a rural setting in Bangladesh

  17 months

Secondary Outcomes (1)

• 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

  17 months

Study Arms (2)

1

EXPERIMENTAL

Promotion of handwashing with soap and maintenance of a fully stocked handwashing station.

Behavioral: Soap

2

NO INTERVENTION

Practice of routine handwashing among the household members

Interventions

Soap BEHAVIORAL

Promotion of handwashing with soap

1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead
• State University of New York at Buffalo: collaborator

Study Sites (1)

Pavani K. Ram

Kishoreganj, Bangladesh

Location

Related Publications (3)

• Jefferson T, Dooley L, Ferroni E, Al-Ansary LA, van Driel ML, Bawazeer GA, Jones MA, Hoffmann TC, Clark J, Beller EM, Glasziou PP, Conly JM. Physical interventions to interrupt or reduce the spread of respiratory viruses. Cochrane Database Syst Rev. 2023 Jan 30;1(1):CD006207. doi: 10.1002/14651858.CD006207.pub6.

  PMID: 36715243 DERIVED

• Jefferson T, Del Mar CB, Dooley L, Ferroni E, Al-Ansary LA, Bawazeer GA, van Driel ML, Jones MA, Thorning S, Beller EM, Clark J, Hoffmann TC, Glasziou PP, Conly JM. Physical interventions to interrupt or reduce the spread of respiratory viruses. Cochrane Database Syst Rev. 2020 Nov 20;11(11):CD006207. doi: 10.1002/14651858.CD006207.pub5.

  PMID: 33215698 DERIVED

• Ram PK, DiVita MA, Khatun-e-Jannat K, Islam M, Krytus K, Cercone E, Sohel BM, Ahmed M, Rahman AM, Rahman M, Yu J, Brooks WA, Azziz-Baumgartner E, Fry AM, Luby SP. Impact of Intensive Handwashing Promotion on Secondary Household Influenza-Like Illness in Rural Bangladesh: Findings from a Randomized Controlled Trial. PLoS One. 2015 Jun 11;10(6):e0125200. doi: 10.1371/journal.pone.0125200. eCollection 2015.

  PMID: 26066651 DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

Soaps

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Detergents; Surface-Active Agents; Specialty Uses of Chemicals; Chemical Actions and Uses; Household Products; Technology, Industry, and Agriculture

Study Officials

• Eduardo Azziz-Baumgartner, MD, MPH

  International Centre for Diarrhoeal Disease Research, Bangladesh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 11, 2009
• First Posted: April 14, 2009
• Study Start: June 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: December 1, 2010
• Last Updated: December 30, 2010

Record last verified: 2010-05

Locations

BA (1)