Evaluation of Novel Antimicrobial Hand Towels

July 29, 2015 updated by: Centers for Disease Control and Prevention
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

449

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Comparison
Hand hygiene education.
Experimental: Intervention
Hand hygiene education and 4 antimicrobial hand towels
Other: Antimicrobial Hand Towel
Novel antimicrobial hand towel.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with diarrheal disease
Time Frame: Within 48 hours of enrollment
The number of participants that experience 3 or more loose or watery stools
Within 48 hours of enrollment

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of participants with respiratory infections
Time Frame: Within 48 hours of enrollment
Within 48 hours of enrollment
Number of participants with a subjective fever
Time Frame: Within 48 hours of enrollment
Within 48 hours of enrollment
Number of participants with a skin infection
Time Frame: Within 48 hours of enrollment
Within 48 hours of enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centers for Disease Control and Prevention

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

June 24, 2015

First Submitted That Met QC Criteria

July 29, 2015

First Posted (Estimate)

July 31, 2015

Study Record Updates

Last Update Posted (Estimate)

July 31, 2015

Last Update Submitted That Met QC Criteria

July 29, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDC-NCEZID-6102

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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