NCT01251679

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,920

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 9, 2008

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

December 1, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 2, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 12, 2012

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

4.6 years

First QC Date

December 1, 2010

Last Update Submit

September 3, 2024

Conditions

Influenza

Keywords

handwashingmasksinfectious disease transmission

Outcome Measures

Primary Outcomes (1)

  • Secondary influenza infection in household members

    To determine the secondary attack rate (SAR) in households with a child with laboratory-confirmed influenza infection.

    21 days

Study Arms (3)

Control

NO INTERVENTION

Control: nutrition, physical activity and smoking cessation education

Hand washing

EXPERIMENTAL

Intervention 1: hand washing education and material

Behavioral: Hand washing

Hand washing and surgical mask

EXPERIMENTAL

Intervention 2: hand washing education and material AND paper surgical face masks

Device: Hand washing and surgical mask

Interventions

Hand washingBEHAVIORAL

hand washing education and material

Hand washing
Hand washing and surgical maskDEVICE

hand washing education and material and paper surgical face masks

Hand washing and surgical mask

Eligibility Criteria

Age1 Month - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • Receipt of influenza vaccine by any household member during the preceding 12 months.
  • Prior participation in HITS.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Sirikit National Institute of Child Health

Ratchathewi, Bangkok, 10400, Thailand

Location

Related 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 transmission. Clin Infect Dis. 2010 Nov 1;51(9):1053-61. doi: 10.1086/656581.

    PMID: 20879867RESULT

  • 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.

    PMID: 19949356RESULT

MeSH Terms

Conditions

Influenza, Human

Interventions

Hand Disinfection

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Hand HygieneHygienePublic HealthEnvironment and Public Health

Study Officials

  • Sonja J Olsen, PhD

    Centers for Disease Control and Prevention

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2010

First Posted

December 2, 2010

Study Start

April 9, 2008

Primary Completion

November 12, 2012

Study Completion

November 1, 2013

Last Updated

September 19, 2024

Record last verified: 2024-09

Locations

TH(1)