Evaluation of Novel Antimicrobial Hand Towels

Fever Clinical Trial

Official title:

Evaluation of Novel Antimicrobial Hand Towels

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02512614
• Other study ID #: CDC-NCEZID-6102
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: June 24, 2015
• Last updated: July 29, 2015
• Start date: March 2012
• Est. completion date: April 2013

Study information

• Verified date: July 2015
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 449
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Respiratory Infections
• Diarrheal Diseases
• Fever
• Infection
• Respiratory Tract Infections
• Skin Diseases, Infectious
• Skin Infection

Intervention

Other:
• Antimicrobial Hand Towel
Novel antimicrobial hand towel.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with diarrheal disease	The number of participants that experience 3 or more loose or watery stools	Within 48 hours of enrollment	No
Secondary	Number of participants with respiratory infections		Within 48 hours of enrollment	No
Secondary	Number of participants with a subjective fever		Within 48 hours of enrollment	No
Secondary	Number of participants with a skin infection		Within 48 hours of enrollment	No