Face Masks for Preventing Influenza Transmission (GRIPMASK)
| Tracking Information | |||||
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| First Received Date ICMJE | October 16, 2008 | ||||
| Last Updated Date | April 22, 2011 | ||||
| Start Date ICMJE | January 2009 | ||||
| Primary Completion Date | September 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
The number of household contacts who will develop within 7 days of the inclusion of the index patient a respiratory syndrome defined by fever> = 37.8 ° C and a cough or a sore throat. [ Time Frame: during the study ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00774774 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Face Masks for Preventing Influenza Transmission | ||||
| Official Title ICMJE | a Randomized Controlled Trial Evaluating the Effectiveness and the Safety of Surgical Masks Wared by the Index Patient for Preventing Secondary Transmission of Influenza A in Households | ||||
| Brief Summary | This work aims to measure the effectiveness of face mask worn by a patient with flu to avoid transmission to other persons in the household. |
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| Detailed Description | Background. Non pharmaceutical interventions, and in particular the wearing of face masks, could play a role in controlling the transmission of influenza in the early stages of the epidemic. In the French pandemic plan, surgical masks are recommended in contagious patients in wards. The effectiveness of such masks in preventing transmission of influenza A virus is unknown. Our project aims to assess the preventive efficacy and tolerance of surgical mask. The primary objective is to measure the decrease of the number of secondary cases of flu in households where the index case will wear a surgical mask during its period of infectiousness (5 days), compared to households where the index case will not be subject to this intervention. Secondary objectives are: (1) to study the feasibility and tolerance of wearing a mask continuously during the period of viral shedding; (2) virological description of infection spreading among household contacts based on virological collections. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE | Influenza Human | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 372 | ||||
| Completion Date | September 2009 | ||||
| Primary Completion Date | September 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Patient seeking medical advice for:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 5 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00774774 | ||||
| Other Study ID Numbers ICMJE | P070160 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | laurent piazza, Department Clinical Research of Developpement | ||||
| Study Sponsor ICMJE | Assistance Publique - Hôpitaux de Paris | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Assistance Publique - Hôpitaux de Paris | ||||
| Verification Date | September 2008 | ||||
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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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