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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | December 11, 2006 | ||||
| Last Updated Date | December 11, 2006 | ||||
| Start Date ICMJE | January 2007 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
secondary infection of influenza within the family | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
compliance of non-pharmaceutical interventions | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Randomized, Controlled, Unblinded, Clinical Trial of the Acceptability and Efficacy of Non-Pharmaceutical Methods in Preventing Spread of Influenza Within the Family | ||||
| Official Title ICMJE | |||||
| 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%. |
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| Detailed Description | |||||
| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Prevention, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE | Influenza | ||||
| Intervention ICMJE | Behavioral: sanitation and personal hygiene | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Not yet recruiting | ||||
| Enrollment ICMJE | 400 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | |||||
| Accepts Healthy Volunteers | |||||
| Contacts ICMJE |
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| Location Countries ICMJE | |||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00410176 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 4335CTIL | ||||
| Study Sponsor ICMJE | Ministry of Health, Israel | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Ministry of Health, Israel | ||||
| Verification Date | December 2006 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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