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Sponsored by: |
Ministry of Health, Israel |
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Information provided by: | Ministry of Health, Israel |
ClinicalTrials.gov Identifier: | NCT00410176 |
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 |
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Influenza |
Behavioral: sanitation and personal hygiene |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
Contact: Manfred S Green, PhD, M.D | 972-3-7371500 ext 203 | m.green@icdc.health.gov.il |
Principal Investigator: | Manfred S Green, PhD, M.D | ICDC |
Study ID Numbers: | 4335CTIL |
Study First Received: | December 11, 2006 |
Last Updated: | December 11, 2006 |
ClinicalTrials.gov Identifier: | NCT00410176 History of Changes |
Health Authority: | Israel: Ethics Commission; Israel: Ministry of Health |
Virus Diseases Respiratory Tract Diseases Respiratory Tract Infections Influenza, Human Orthomyxoviridae Infections |
Virus Diseases RNA Virus Infections Respiratory Tract Diseases |
Respiratory Tract Infections Influenza, Human Orthomyxoviridae Infections |