A Randomized, Controlled, Unblinded, Clinical Trial of the Acceptability and Efficacy of Non-Pharmaceutical Methods in Preventing Spread of Influenza Within the Family

NCT00410176 | Unknown

• 1 other identifier: 4335CTIL
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief Summary

The proposed study will evaluate whether the use of non-pharmaceutical methods, such as surgical masks, isolation of patients and personal hygiene, are acceptable and effective in preventing the spread of influenza within the family.This will be achieved by conducting a randomized, controlled, unblinded, clinical trial. Family members of an index case with influenza like illness, will be randomly allocated to two groups. In the intervention group, family members will receive comprehensive guidance about sanitation and hygiene, as well as surgical masks to wear whenever in close contact (3 feet / 1 meter) with the index case. In addition, they will be asked to isolate the index case as much as possible. In the control group, family members will receive only standard guidance about sanitation and hygiene relevant for reducing the transmission of influenza. The primary end-point of the study will be secondary infection of influenza of at least one of the family members in order to asses the efficacy of the interventions. In addition, the compliance to those interventions will be evaluated. The study hypothesis is that use of non-pharmaceutical methods will be acceptable and will reduce the secondary infection rate among them by 50%.

Conditions

Influenza

Outcome Measures

Primary Outcomes (1)

• secondary infection of influenza within the family

Secondary Outcomes (1)

• compliance of non-pharmaceutical interventions

Interventions

sanitation and personal hygiene BEHAVIORAL

Eligibility Criteria

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

You may qualify if:

• Family members of an index case with influenza-like illness (ILI) during the first two days of his illness.
• No limitations will be given regarding the number of family members.

You may not qualify if:

• Presence of another household member with ILI during the previous two weeks.

Sponsors & Collaborators

• Ministry of Health, Israel: lead

MeSH Terms

Conditions

Influenza, Human

Interventions

Sanitation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Communicable Disease Control; Public Health Practice; Public Health; Environment and Public Health

Study Officials

• Manfred S Green, PhD, M.D

  ICDC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manfred S Green, PhD, M.D

CONTACT

972-3-7371500; m.green@icdc.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: December 11, 2006
• First Posted: December 12, 2006
• Study Start: January 1, 2007
• Last Updated: December 12, 2006

Record last verified: 2006-12