Household Influenza Transmission Study

Influenza Clinical Trial

— HITS  

Official title:

Study to Assess Effectiveness of Nonpharmaceutical Interventions (Handwashing, Face Mask Use) to Prevent Influenza Transmission in Households

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01251679
• Other study ID #: CDC-NCIRD-5288
• Status: Completed
• Phase: N/A
• Start date: April 9, 2008
• Est. completion date: November 2013

Study information

• Verified date: September 2012
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2920
• Est. completion date: November 2013
• Est. primary completion date: November 12, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 15 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Behavioral:
• Hand washing
hand washing education and material

Device:
• Hand washing and surgical mask
hand washing education and material and paper surgical face masks

Locations

Country	Name	City	State
Thailand	Queen Sirikit National Institute of Child Health	Ratchathewi	Bangkok

Sponsors (3)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention	Armed Forces Research Institute of Medical Sciences, Thailand, Ministry of Health, Thailand

Country where clinical trial is conducted

Thailand, 

References & Publications (2)

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 tra — View Citation

Suntarattiwong 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 childre — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Secondary influenza infection in household members		21 days