InfluenzaHITSNCT01251679
Household Influenza Transmission Study
A study testing Hand washing and Hand washing and surgical mask in people with Influenza, run by Centers for Disease Control and Prevention at 1 site in Thailand.
Trial summary
The purpose of this study is to determine whether nonpharmaceutical interventions (i.e., handwashing and masks) reduce secondary transmission of influenza in households. Read more about this study
- Who is it for?
- Ages 1 month to 15 years
- Conditions the study is for
- Influenza
- What is being tested?
- Hand washing and Hand washing and surgical mask
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,920 participants
- Where
- 1 siteThailand
- Study dates
- 9 Apr 2008to Nov 2013
- 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 1 month to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child, 1 month through 15 years of age
- Resident of Bangkok Metropolitan Area
- Outpatient of Queen Sirikit National Institute of Child Health Children's
- Hospital seen during HITS' active study period
- Positive influenza rapid test result from patient presenting with influenza-like illness
- In addition to the index case, consent must be obtained from at least 2 household members ≥1 month of age who plan to sleep inside the house for a period of at least 21 days from the time of enrollment
Who cannot join
- Illness onset 48 hours or more before presentation and influenza testing at Queen Sirikit National Institute of Child Health Children's Hospital
- Treatment with influenza antiviral medications since it may decrease secondary attack rate
- Children who are at high risk for severe influenza disease (e.g., chronic lung disease, renal disease, chemotherapy for cancer, long-term aspirin therapy)
- A history of influenza-like illness in another household member that precedes the index case by 7 days or less will lead to exclusion of the household because the source of influenza infection for secondary cases is uncertain.
- Receipt of influenza vaccine by any household member during the preceding 12 months.
- Prior participation in HITS.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Queen Sirikit National Institute of Child Health
Ratchathewi, Bangkok, 10400
About this study
Official title: Study to Assess Effectiveness of Nonpharmaceutical Interventions (Handwashing, Face Mask Use) to Prevent Influenza Transmission in Households
The purpose of this study is to determine whether nonpharmaceutical interventions (i.e., handwashing and masks) reduce secondary transmission of influenza in households.
Read the detailed description
HITS is a multi-year project that will prospectively identify laboratory-confirmed influenza infected children. Secondary influenza infection will then be examined among members of the child's household and effectiveness of non-pharmaceutical interventions to decrease secondary infection will be assessed. The pediatric influenza-infected index case will be identified by rapid influenza testing and their household will then be enrolled and randomized to one of three study arms: control, hand washing (Intervention 1), and hand washing and mask use (Intervention 2). Following enrollment, at days 0, 3 and 7, all household participants will be tested: the index case will be assessed for influenza viral shedding and household members will be assessed for secondary influenza infection. This study is being conducted at Queen Sirikit Institute for Child Health in Bangkok.
- Conditions
- Influenza
- Being tested
- Hand washing, Hand washing and surgical mask
- Keywords
- handwashing, masks, infectious disease transmission
- 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 washingBehavioural
hand washing education and material
Hand washing and surgical maskDevice
hand washing education and material and paper surgical face masks
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Control: nutrition, physical activity and smoking cessation education |
| Hand washing | Experimental | Intervention 1: hand washing education and material Receives: Behavioral: Hand washing |
| Hand washing and surgical mask | Experimental | Intervention 2: hand washing education and material AND paper surgical face masks Receives: Device: Hand washing and surgical mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Secondary influenza infection in household members
To determine the secondary attack rate (SAR) in households with a child with laboratory-confirmed influenza infection.
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2010 (estimated)
- Study start9 Apr 2008
- Primary completion12 Nov 2012
- Study completionNov 2013
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,920 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- Ministry of Health, Thailand, Armed Forces Research Institute of Medical Sciences, Thailand
- Responsible party
- Sponsor
- Investigators
- Sonja J Olsen, PhD, Principal investigator, Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01251679
- Sponsor's protocol ID
- CDC-NCIRD-5288
- Acronym
- HITS
- Status last verified
- Sep 2024
- First submitted
- 1 Dec 2010
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Simmerman JM, Suntarattiwong P, Levy J, Gibbons RV, Cruz C, Shaman J, Jarman RG, Chotpitayasunondh T. Influenza virus contamination of common household surfaces during the 2009 influenza A (H1N1) pandemic in Bangkok, Thailand: implications for contact transmission. Clin Infect Dis. 2010 Nov 1;51(9):1053-61. doi: 10.1086/656581.
PubMed 20879867Suntarattiwong P, Jarman RG, Levy J, Baggett HC, Gibbons RV, Chotpitayasunondh T, Simmerman JM. Clinical performance of a rapid influenza test and comparison of nasal versus throat swabs to detect 2009 pandemic influenza A (H1N1) infection in Thai children. Pediatr Infect Dis J. 2010 Apr;29(4):366-7. doi: 10.1097/INF.0b013e3181c6f05c.
PubMed 19949356
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Assess Effectiveness of Nonpharmaceutical Interventions (Handwashing, Face Mask Use) to Prevent Influenza Transmission in Households
- ClinicalTrials.gov ID
- NCT01251679
- Acronym / sponsor ID
- HITS / CDC-NCIRD-5288
- Conditions
- Influenza
- Keywords
- handwashing, masks, infectious disease transmission
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,920 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- Ministry of Health, Thailand, Armed Forces Research Institute of Medical Sciences, Thailand
- Study start
- 9 Apr 2008 (actual)
- Primary completion
- 12 Nov 2012 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 2 Dec 2010 (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.
The purpose of this study is to determine whether nonpharmaceutical interventions (i.e., handwashing and masks) reduce secondary transmission of influenza in households.
Detailed description
HITS is a multi-year project that will prospectively identify laboratory-confirmed influenza infected children. Secondary influenza infection will then be examined among members of the child's household and effectiveness of non-pharmaceutical interventions to decrease secondary infection will be assessed. The pediatric influenza-infected index case will be identified by rapid influenza testing and their household will then be enrolled and randomized to one of three study arms: control, hand washing (Intervention 1), and hand washing and mask use (Intervention 2). Following enrollment, at days 0, 3 and 7, all household participants will be tested: the index case will be assessed for influenza viral shedding and household members will be assessed for secondary influenza infection. This study is being conducted at Queen Sirikit Institute for Child Health in Bangkok.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Control: nutrition, physical activity and smoking cessation education |
| Hand washing | Experimental | Behavioral: Hand washingIntervention 1: hand washing education and material |
| Hand washing and surgical mask | Experimental | Device: Hand washing and surgical maskIntervention 2: hand washing education and material AND paper surgical face masks |
Who may qualify
- Ages
- 1 month to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Child, 1 month through 15 years of age
- Resident of Bangkok Metropolitan Area
- Outpatient of Queen Sirikit National Institute of Child Health Children's
- Hospital seen during HITS' active study period
- Positive influenza rapid test result from patient presenting with influenza-like illness
Key exclusion criteria (6 listed)
- Illness onset 48 hours or more before presentation and influenza testing at Queen Sirikit National Institute of Child Health Children's Hospital
- Treatment with influenza antiviral medications since it may decrease secondary attack rate
- Children who are at high risk for severe influenza disease (e.g., chronic lung disease, renal disease, chemotherapy for cancer, long-term aspirin therapy)
- A history of influenza-like illness in another household member that precedes the index case by 7 days or less will lead to exclusion of the household because the source of influenza infection for secondary cases is uncertain.
- Receipt of influenza vaccine by any household member during the preceding 12 months.
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 washinghand washing education and material | Behavioural | Hand washing |
| Hand washing and surgical maskhand washing education and material and paper surgical face masks | Device | Hand washing and surgical mask |
Primary outcome
Secondary influenza infection in household members
Time frame: 21 days
To determine the secondary attack rate (SAR) in households with a child with laboratory-confirmed influenza infection.
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 19 Sep 2024.
- Results publication: PubMed 20879867Simmerman JM, Suntarattiwong P, Levy J, Gibbons RV, Cruz C, Shaman J, Jarman RG, Chotpitayasunondh T. Influenza virus contamination of common household surfaces during the 2009 influenza A (H1N1) pandemic in Bangkok, Thailand: implications for contact transmission. Clin Infect Dis. 2010 Nov 1;51(9):1053-61. doi: 10.1086/656581.
- Results publication: PubMed 19949356Suntarattiwong P, Jarman RG, Levy J, Baggett HC, Gibbons RV, Chotpitayasunondh T, Simmerman JM. Clinical performance of a rapid influenza test and comparison of nasal versus throat swabs to detect 2009 pandemic influenza A (H1N1) infection in Thai children. Pediatr Infect Dis J. 2010 Apr;29(4):366-7. doi: 10.1097/INF.0b013e3181c6f05c.
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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.
Sonja J Olsen, PhD principal investigator
Centers for Disease Control and Prevention
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 washing and Hand washing and surgical mask in people with Influenza, run by Centers for Disease Control and Prevention at 1 site in Thailand.
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 6 inclusion and 6 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 19 Sep 2024. 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 Thailand. 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 in household members (time frame: 21 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 NCT01251679, 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 19 Sep 2024.