InfluenzaNCT00425893
A Randomised Controlled Trial of Face Masks and Hand Hygiene in Reducing Influenza Transmission in Households
A study testing hand hygiene, health education and face masks in people with Influenza, run by Centers for Disease Control and Prevention at 1 site in China.
Trial summary
This study will test the effectiveness of face masks and hand cleaning in preventing the spread of influenza within households Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- hand hygiene, health education and face masks
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,069 participants
- Where
- 1 siteChina
- Study dates
- Feb 2007to Nov 2008
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Member of family with influenza infected member
Who cannot join
- Age less than 2 yr
Trial locations and contacts
1 site in 1 country.
About this study
This study will test the effectiveness of face masks and hand cleaning in preventing the spread of influenza within households
Read the detailed description
Randomised controlled trial of surgical masks and alcohol hand wash among approximately 6069 Hong Kong residents who have a household member diagnosed with influenza. Influenza in index member and secondary infection will be documented with rapid influenza tests and PCR. Minimal risk to participants.
- Conditions
- Influenza
- Being tested
- hand hygiene, health education, face masks
- Keywords
- influenza, masks, transmission, hand hygiene, non-pharmacologic interventions
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hand hygieneBehavioural
alcohol-based hand wash
health educationOther
Proper nutrition, etc.
face masksDevice
face masks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | health education Receives: Other: health education |
| 2 | Experimental | hand hygiene Receives: Behavioral: hand hygiene |
| 3 | Experimental | masks and hand hygiene Receives: Behavioral: hand hygiene; Device: face masks |
What is being measured
The primary outcome is the main question the study is designed to answer.
secondary influenza infection
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2007 (estimated)
- Study startFeb 2007
- Primary completionSep 2008
- Study completionNov 2008
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 InfluenzaStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6,069 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- The University of Hong Kong
- Investigators
- Benjamin J Cowling, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00425893
- Sponsor's protocol ID
- CDC-NCCID-UCI000439A
- Other IDs
- CDC Grant# 1 U01 CI000439-01
- Status last verified
- Apr 2012
- First submitted
- 19 Jan 2007
- Last updated
- 13 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Cowling BJ, Chan KH, Fang VJ, Cheng CK, Fung RO, Wai W, Sin J, Seto WH, Yung R, Chu DW, Chiu BC, Lee PW, Chiu MC, Lee HC, Uyeki TM, Houck PM, Peiris JS, Leung GM. Facemasks and hand hygiene to prevent influenza transmission in households: a cluster randomized trial. Ann Intern Med. 2009 Oct 6;151(7):437-46. doi: 10.7326/0003-4819-151-7-200910060-00142. Epub 2009 Aug 3.
PubMed 19652172Cowling BJ, Fung RO, Cheng CK, Fang VJ, Chan KH, Seto WH, Yung R, Chiu B, Lee P, Uyeki TM, Houck PM, Peiris JS, Leung GM. Preliminary findings of a randomized trial of non-pharmaceutical interventions to prevent influenza transmission in households. PLoS One. 2008 May 7;3(5):e2101. doi: 10.1371/journal.pone.0002101.
PubMed 18461182
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of Face Masks and Hand Hygiene in Reducing Influenza Transmission in Households
- ClinicalTrials.gov ID
- NCT00425893
- Acronym / sponsor ID
- CDC-NCCID-UCI000439A
- Conditions
- Influenza
- Keywords
- influenza, masks, transmission, hand hygiene, non-pharmacologic interventions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,069 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- The University of Hong Kong
- Study start
- Feb 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 23 Jan 2007 (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 study will test the effectiveness of face masks and hand cleaning in preventing the spread of influenza within households
Detailed description
Randomised controlled trial of surgical masks and alcohol hand wash among approximately 6069 Hong Kong residents who have a household member diagnosed with influenza. Influenza in index member and secondary infection will be documented with rapid influenza tests and PCR. Minimal risk to participants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: health educationhealth education |
| 2 | Experimental | Behavioral: hand hygienehand hygiene |
| 3 | Experimental | Behavioral: hand hygiene, Device: face masksmasks and hand hygiene |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Member of family with influenza infected member
Key exclusion criteria (1 listed)
- Age less than 2 yr
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 |
|---|---|---|
| hand hygienealcohol-based hand wash | Behavioural | 2, 3 |
| health educationProper nutrition, etc. | Other | 1 |
| face masksface masks | Device | 3 |
Primary outcome
secondary influenza infection
Time frame: 7 days
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 13 Apr 2012.
- Derived from this study: PubMed 19652172Cowling BJ, Chan KH, Fang VJ, Cheng CK, Fung RO, Wai W, Sin J, Seto WH, Yung R, Chu DW, Chiu BC, Lee PW, Chiu MC, Lee HC, Uyeki TM, Houck PM, Peiris JS, Leung GM. Facemasks and hand hygiene to prevent influenza transmission in households: a cluster randomized trial. Ann Intern Med. 2009 Oct 6;151(7):437-46. doi: 10.7326/0003-4819-151-7-200910060-00142. Epub 2009 Aug 3.
- Derived from this study: PubMed 18461182Cowling BJ, Fung RO, Cheng CK, Fang VJ, Chan KH, Seto WH, Yung R, Chiu B, Lee P, Uyeki TM, Houck PM, Peiris JS, Leung GM. Preliminary findings of a randomized trial of non-pharmaceutical interventions to prevent influenza transmission in households. PLoS One. 2008 May 7;3(5):e2101. doi: 10.1371/journal.pone.0002101.
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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.
Benjamin J Cowling, PhD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hand hygiene, health education and face masks in people with Influenza, run by Centers for Disease Control and Prevention at 1 site in China.
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 1 inclusion and 1 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 13 Apr 2012. 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 China. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
secondary influenza infection (time frame: 7 days). 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 NCT00425893, 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 13 Apr 2012.