Project to Investigate Ways to Reduce the Spread of Influenza in Schools and Households With Children

NCT00446628 | Completed DMC

• 2 other identifiers: CDC-NCPDCID-CC-0612047CDC-U01 CI000435-01
• Study Type: interventional
• Target: 3,360
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to understand the spread of influenza (flu) in schools and households with elementary (K-5) school children, and develop ways to reduce the flu using non-pharmaceutical means.

Conditions

Influenza

Keywords

Non-pharmaceutical; influenza; pandemic

Study Arms (2)

intervention

EXPERIMENTAL

Five elementary school received intervention consistin of training in hand and respiratory hygiene, and access to hand sanitizer

Behavioral: behaviors reducing spread of influenza

control

NO INTERVENTION

Five elementary school received no training or hand sanitizer.

Interventions

behaviors reducing spread of influenza BEHAVIORAL

Non-pharmaceutical interventions for flu prevention

intervention

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Students in grades K-8 with a current influenza-like illness (ILI) during flu season.ILI defined as an oral or aural temperature \> 100 °F AND either new onset cough or sore throat.Flu season is defined as December, 2006 through March/April, 2007.
• Parental consent and student assent.
• Shares living space with K-8 child who has current influenza infection.
• Parental consent and child assent in the case of minors.
• Individual consent if over the age of 18.
• Will continue in the study even if student with confirmed influenza withdraws from the study.

You may not qualify if:

• The participant has a medical or mental health condition which in the judgment of the investigator is a barrier to safe participation.
• The participant is unable to tolerate a swab or capillary finger stick.
• There is a delay in notification or testing such that symptoms have resolved.
• The participant has a medical or mental health condition which in the judgment of the investigator is a barrier to safe participation.
• The participant is younger than 6 months.
• The participant is unable to tolerate a swab or capillary finger stick.

Sponsors & Collaborators

• Kiren Mitruka: lead

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Donald S Burke, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Sam Stebbins, MD, MPH

  University of Pittsburgh School of Public Health

  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 INVESTIGATOR
• PI Title: Medical officer

Study Record Dates

• First Submitted: March 12, 2007
• First Posted: March 13, 2007
• Study Start: January 1, 2007
• Primary Completion: May 1, 2009
• Study Completion: September 1, 2009
• Last Updated: January 27, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)