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Stopping Upper Respiratory Infections and Flu in the Family: The Stuffy Trial

Study acronym: STUFFY
StatusCompleted
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Amendment history

  1. Minor

    Interventions: Hand hygiene and educational material (Behavioral), Mask, alcohol and hand sanitizer (Device) to Education (Behavioral), Face Masks (Device), Hand Sanitizer (Device)

    Eligibility criteria expanded, about 68 words; Study arms: 0 to 3

    Show what changed: Eligibility criteria
    Inclusion Criteria: Households which includewith at least three persons, atmembers At least one of whom is a preschool or elementary school-aged child, livingin the household Residence in Northern Manhattan, Ability haveto speak English or Spanish Access to a telephone, Willingness speakto Spanishparticipate in regular symptom reporting and home visits Not routinely using alcohol-based hand sanitizer at baseline Exclusion Criteria: Households with fewer than three members No preschool or elementary school-aged child in the household Inability to communicate in English or Spanish No access to a [...]

    Study Status, Study Design, Arms and Interventions, Outcome Measures, Eligibilityv4

  2. Minor

    Study Identification, Study Status, Sponsor/Collaborators

    Re-verified, no change to tracked fields

    v3

  3. Minor

    Trial status: Recruiting to Completed

    Enrollment target: 2025 to 2788; Primary completion date: Jun 2008; Completion date: Sep 2008 to Jun 2008; and 1 more

    Show all 5 changes in this update
    • Minor Trial status: Recruiting to Completed
    • Minor Enrollment target: 2025 to 2788
    • Minor Primary completion date: Jun 2008
    • Minor Completion date: Sep 2008 to Jun 2008
    • Minor Site details revised

    Study Status, Sponsor/Collaborators, Study Design, Contacts/Locationsv2

  4. Minor

    Study First Submitted

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Colds and flu cause much loss of work and school. The purpose of this study is to try to reduce the transmission of colds and flu among household members with one of three interventions: some educational material, educational material and use of alcohol hand sanitizers, and educational material and use of alcohol hand sanitizers as well as face masks when somebody has symptoms of the flu. We will recruit 450 households in Northern Manhattan and each household will be randomly assigned to one of these three groups. We will then follow these households for 15 months to see how often they get cold and flu symptoms. We will also look at antibiotic use practices for symptoms of colds and influenza ; household member knowledge of prevention and treatment strategies for pandemic influenza and viral URIs; and rates of influenza vaccination among household members. When someone in the study has serious flu symptoms such as a high fever and cough or sore throat, we will also obtain a nasal culture (by swabbing the nose) to see if there is flu virus present.
Trial Details
NCT Number NCT00448981
Lead Sponsor Centers for Disease Control and Prevention
Conditions Respiratory Tract Infections, Common Cold
Enrollment 2,788 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov