Clinical trial NCT01251679: Household Influenza Transmission Study
Official title: Study to Assess Effectiveness of Nonpharmaceutical Interventions (Handwashing, Face Mask Use) to Prevent Influenza Transmission in Households
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Influenza
Keywords: handwashing
masks
infectious disease transmission
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
Collaborators: name: Ministry of Health, Thailand
name: Armed Forces Research Institute of Medical Sciences, Thailand
First posted: 2010-12-02
Enrollment: 2920
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Secondary influenza infection in household members
timeFrame: 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: Ratchathewi
country: Thailand
facility: Queen Sirikit National Institute of Child Health
state: Bangkok
Study officials:
affiliation: Centers for Disease Control and Prevention
name: Sonja J Olsen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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 children. Pediatr Infect Dis J. 2010 Apr;29(4):366-7. doi: 10.1097/INF.0b013e3181c6f05c.