NCT02512614

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
449

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2012

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

June 24, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 31, 2015

Completed
Last Updated

July 31, 2015

Status Verified

July 1, 2015

Enrollment Period

1.1 years

First QC Date

June 24, 2015

Last Update Submit

July 29, 2015

Conditions

Diarrheal DiseasesAcute Respiratory InfectionsFeverSkin Infection

Outcome Measures

Primary Outcomes (1)

  • Number of participants with diarrheal disease

    The number of participants that experience 3 or more loose or watery stools

    Within 48 hours of enrollment

Secondary Outcomes (3)

  • Number of participants with respiratory infections

    Within 48 hours of enrollment

  • Number of participants with a subjective fever

    Within 48 hours of enrollment

  • Number of participants with a skin infection

    Within 48 hours of enrollment

Study Arms (2)

Comparison

NO INTERVENTION

Hand hygiene education.

Intervention

EXPERIMENTAL

Hand hygiene education and 4 antimicrobial hand towels

Other: Antimicrobial Hand Towel

Interventions

Antimicrobial Hand TowelOTHER

Novel antimicrobial hand towel.

Intervention

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Mother of a child \<2 years old

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

FeverCellulitis

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsSkin Diseases, InfectiousInfectionsSuppurationConnective Tissue DiseasesSkin and Connective Tissue DiseasesInflammationPathologic Processes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2015

First Posted

July 31, 2015

Study Start

March 1, 2012

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

July 31, 2015

Record last verified: 2015-07