Influenza HumanPhase 4GRIPMASKNCT00774774
Face Masks for Preventing Influenza Transmission
A Phase 4 study testing Face mask in people with Influenza Human, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Influenza Human
- What is being tested?
- Face mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 372 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2009to Sep 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient seeking medical advice for:
- For symptoms less than 48 hours, combining fever> = 37.8 ° C and a cough,
- during the period of a seasonal influenza epidemic (as defined by the Sentinel network)
- Older than 5 years
- And living in a household size between 3 to 8..
- The patient is the first case in the household (index patient). The patient has a positive rapid influenza A test.
- Informed consent.
- Affiliation to the social security.
Who cannot join
- When concomitant influenza cases are known in other householders
- When the patient is suffering from asthma or COPD (ongoing treatment):
- Hospitalization.
- Treatment by a neuraminidase inhibitor.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Influenza Human
- Being tested
- control, Face mask
- Keywords
- Influenza, human, Masks, Disease Transmission, Horizontal
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
controlDevice
Non sterile surgical mask,high filtration "AEROKYN",type 2 with eardrop
Face maskDevice
Non sterile surgical mask, high filtration "AEROKYN", type 2 with eardrop Masks will be worn at home by the patient over a period of 5 days following inclusion, whenever a member of the household will attend the same room or in other confined space (eg car), and changed after 3 hours of consecutive use or sooner if they are tor
Masks will not be worn:
- during the night,
- when the patient is alone in the room. Moreover, for all households, an incentive in nocturnal isolation of index-patient will be recommended
| Study group | Role | What they receive |
|---|---|---|
| 2 | Placebo comparator | No intervention Receives: Device: control |
| 1 | Experimental | Mask Receives: Device: Face mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: during the study
Secondary outcomes (9)
clinical events in all household members on the entire monitoring period (21 days).
Measured: 21 days
Adverse events related to wearing a mask - a safety issue.
Measured: during the study
Number of days of wearing a mask, number of masks used.
Measured: during the study
Drug-consumption, in particular antibiotics
Measured: during the study
Sick-leave from work (for adults contacts), or from school (for children of school age).
Measured: during the study
Quality of life in the index patient.
Measured: during the study
Infection with influenza virus at different time, among all household members.
Measured: during the study
Quantification of viral load in patients infected.
Measured: during the study
Characterization of viruses isolated (sub-type and sequence of the portion of HA1 gene for haemagglutinin).
Measured: during the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2008 (estimated)
- Study startJan 2009
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Influenza HumanStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 372 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Investigators
- Fabrice CARRAT, MD PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00774774
- Sponsor's protocol ID
- P070160
- Acronym
- GRIPMASK
- Status last verified
- Sep 2008
- First submitted
- 16 Oct 2008
- Last updated
- 26 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Sies H, Akerboom TP, Tager JM. Mitochondrial and cytosolic NADPH systems and isocitrate dehydrogenase indicator metabolites during ureogensis from ammonia in isolated rat hepatocytes. Eur J Biochem. 1977 Jan;72(2):301-7. doi: 10.1111/j.1432-1033.1977.tb11253.x.
PubMed 13998Canini L, Andreoletti L, Ferrari P, D'Angelo R, Blanchon T, Lemaitre M, Filleul L, Ferry JP, Desmaizieres M, Smadja S, Valleron AJ, Carrat F. Surgical mask to prevent influenza transmission in households: a cluster randomized trial. PLoS One. 2010 Nov 17;5(11):e13998. doi: 10.1371/journal.pone.0013998.
PubMed 21103330
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00774774
- Acronym / sponsor ID
- GRIPMASK / P070160
- Conditions
- Influenza Human
- Keywords
- Influenza, human, Masks, Disease Transmission, Horizontal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 372 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 17 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Placebo comparator | Device: controlNo intervention |
| 1 | Experimental | Device: Face maskMask |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- For symptoms less than 48 hours, combining fever> = 37.8 ° C and a cough,
- during the period of a seasonal influenza epidemic (as defined by the Sentinel network)
- Older than 5 years
- And living in a household size between 3 to 8..
- The patient is the first case in the household (index patient). The patient has a positive rapid influenza A test.
Key exclusion criteria (4 listed)
- When concomitant influenza cases are known in other householders
- When the patient is suffering from asthma or COPD (ongoing treatment):
- Hospitalization.
- Treatment by a neuraminidase inhibitor.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| controlNon sterile surgical mask,high filtration "AEROKYN",type 2 with eardrop | Device | 2 |
| Face maskNon sterile surgical mask, high filtration "AEROKYN", type 2 with eardrop Masks will be worn at home by the patient over a period of 5 days following inclusion, whenever a member of the household will attend the same room or in other confined space (eg car), and changed after 3 hours of consecutive use or sooner if they are tor Masks will not be worn: * during the night, * when the patient is alone in the room. Moreover, for all households, an incentive in nocturnal isolation of index-patient will be recommended | Device | 1 |
Primary outcome
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
9 secondary outcomes
clinical events in all household members on the entire monitoring period (21 days).
Time frame: 21 days
Adverse events related to wearing a mask - a safety issue.
Time frame: during the study
Number of days of wearing a mask, number of masks used.
Time frame: during the study
Drug-consumption, in particular antibiotics
Time frame: during the study
Sick-leave from work (for adults contacts), or from school (for children of school age).
Time frame: during the study
Quality of life in the index patient.
Time frame: during the study
Infection with influenza virus at different time, among all household members.
Time frame: during the study
Quantification of viral load in patients infected.
Time frame: during the study
Characterization of viruses isolated (sub-type and sequence of the portion of HA1 gene for haemagglutinin).
Time frame: during the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2011.
- Results publication: PubMed 13998Sies H, Akerboom TP, Tager JM. Mitochondrial and cytosolic NADPH systems and isocitrate dehydrogenase indicator metabolites during ureogensis from ammonia in isolated rat hepatocytes. Eur J Biochem. 1977 Jan;72(2):301-7. doi: 10.1111/j.1432-1033.1977.tb11253.x.
- Derived from this study: PubMed 21103330Canini L, Andreoletti L, Ferrari P, D'Angelo R, Blanchon T, Lemaitre M, Filleul L, Ferry JP, Desmaizieres M, Smadja S, Valleron AJ, Carrat F. Surgical mask to prevent influenza transmission in households: a cluster randomized trial. PLoS One. 2010 Nov 17;5(11):e13998. doi: 10.1371/journal.pone.0013998.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabrice CARRAT, MD PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Face mask in people with Influenza Human, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00774774, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2011.