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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2006 by Ministry of Health, Israel.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00410176
First Posted: December 12, 2006
Last Update Posted: December 12, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Ministry of Health, Israel
  Purpose

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%.


Condition Intervention
Influenza Behavioral: sanitation and personal hygiene

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Ministry of Health, Israel:

Primary Outcome Measures:
  • secondary infection of influenza within the family

Secondary Outcome Measures:
  • compliance of non-pharmaceutical interventions

Estimated Enrollment: 400
Study Start Date: January 2007
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Presence of another household member with ILI during the previous two weeks.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00410176


Contacts
Contact: Manfred S Green, PhD, M.D 972-3-7371500 ext 203 m.green@icdc.health.gov.il

Sponsors and Collaborators
Ministry of Health, Israel
Investigators
Principal Investigator: Manfred S Green, PhD, M.D ICDC
  More Information

ClinicalTrials.gov Identifier: NCT00410176     History of Changes
Other Study ID Numbers: 4335CTIL
First Submitted: December 11, 2006
First Posted: December 12, 2006
Last Update Posted: December 12, 2006
Last Verified: December 2006

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