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Evaluation of Novel Antimicrobial Hand Towels

Primary Purpose

Diarrheal Diseases, Acute Respiratory Infections, Fever

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Antimicrobial Hand Towel
Sponsored by
Centers for Disease Control and Prevention
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diarrheal Diseases

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Mother of a child <2 years old

Exclusion Criteria:

  • Inaccessible enumeration area in the rainy season
  • Multiple eligible children in a single compound
  • Moved between census and round 1

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Comparison

    Intervention

    Arm Description

    Hand hygiene education.

    Hand hygiene education and 4 antimicrobial hand towels

    Outcomes

    Primary Outcome Measures

    Number of participants with diarrheal disease
    The number of participants that experience 3 or more loose or watery stools

    Secondary Outcome Measures

    Number of participants with respiratory infections
    Number of participants with a subjective fever
    Number of participants with a skin infection

    Full Information

    First Posted
    June 24, 2015
    Last Updated
    July 29, 2015
    Sponsor
    Centers for Disease Control and Prevention
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02512614
    Brief Title
    Evaluation of Novel Antimicrobial Hand Towels
    Official Title
    Evaluation of Novel Antimicrobial Hand Towels
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2012 (undefined)
    Primary Completion Date
    April 2013 (Actual)
    Study Completion Date
    April 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Centers for Disease Control and Prevention

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    In March 2012, the investigators initiated a prospective, cluster-randomized, controlled field trial in Kisumu County, located in an area in western Kenya which has the highest under-five mortality rate in Kenya with 149 childhood deaths per 1,000 live births 9. The study was designed to evaluate the effectiveness of an antimicrobial hand towel (hereafter referred to as towel) in preventing diarrheal diseases, acute respiratory infections, self-reported fever, and skin infections in children <2 years old.
    Detailed Description
    In March 2012, the investigators initiated a prospective, cluster-randomized, controlled field trial in Kisumu County, located in an area in western Kenya which has the highest under-five mortality rate in Kenya with 149 childhood deaths per 1,000 live births 9. The study was designed to evaluate the effectiveness of an antimicrobial hand towel (hereafter referred to as towel) in preventing diarrheal diseases, acute respiratory infections (ARIs), self-reported fever, and skin infections in children <2 years old.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diarrheal Diseases, Acute Respiratory Infections, Fever, Skin Infection

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    449 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Comparison
    Arm Type
    No Intervention
    Arm Description
    Hand hygiene education.
    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    Hand hygiene education and 4 antimicrobial hand towels
    Intervention Type
    Other
    Intervention Name(s)
    Antimicrobial Hand Towel
    Intervention Description
    Novel antimicrobial hand towel.
    Primary Outcome Measure Information:
    Title
    Number of participants with diarrheal disease
    Description
    The number of participants that experience 3 or more loose or watery stools
    Time Frame
    Within 48 hours of enrollment
    Secondary Outcome Measure Information:
    Title
    Number of participants with respiratory infections
    Time Frame
    Within 48 hours of enrollment
    Title
    Number of participants with a subjective fever
    Time Frame
    Within 48 hours of enrollment
    Title
    Number of participants with a skin infection
    Time Frame
    Within 48 hours of enrollment

    10. Eligibility

    Sex
    Female
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Mother of a child <2 years old Exclusion Criteria: Inaccessible enumeration area in the rainy season Multiple eligible children in a single compound Moved between census and round 1

    12. IPD Sharing Statement

    Learn more about this trial

    Evaluation of Novel Antimicrobial Hand Towels

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