Evaluation of Novel Antimicrobial Hand Towels

Phase 2

Completed

• Conditions: Fever; Diarrheal Diseases; Acute Respiratory Infections; Skin Infection
• Interventions: Other: Antimicrobial Hand Towel

• Registration Number: NCT02512614
• Lead Sponsor: Centers for Disease Control and Prevention

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.

Study Timeline

• Study Start: 2012-03
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Study First Submitted: 2015-06-24
• Status Verified: 2015-07
• Study First Submitted QC: 2015-07-29
• Last Update Submitted: 2015-07-29
• Study First Posted: 2015-07-31
• Last Update Posted: 2015-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 449

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Antimicrobial Hand Towel	Hand hygiene education and 4 antimicrobial hand towels

Primary Outcome Measures

Name	Time	Method
Number of participants with diarrheal disease	Within 48 hours of enrollment	The number of participants that experience 3 or more loose or watery stools

Secondary Outcome Measures

Name	Time	Method
Number of participants with a subjective fever	Within 48 hours of enrollment
Number of participants with respiratory infections	Within 48 hours of enrollment
Number of participants with a skin infection	Within 48 hours of enrollment