Evaluation of Novel Antimicrobial Hand Towels | NCT02512614

Studies
Evaluation of Novel Antimicrobial Hand Towels

NCT02512614

Sponsor

Centers for Disease Control and Prevention

Status

Completed

Last Update Posted

Jul 31, 2015Estimated

Enrollment

449Actual

Phase

Phase 2Phase 3

Conditions

Diarrheal Diseases
Acute Respiratory Infections
Fever
Skin Infection

Interventions

Antimicrobial Hand Towel

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2012

Primary Completion Date

Apr 2013Actual

Completion Date

Apr 2013Actual

First Submitted Date

Jun 24, 2015

First Submission Date that Met QC Criteria

Jul 29, 2015

First Posted Date

Jul 31, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 29, 2015

Last Update Posted Date

Jul 31, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

449Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Comparison	No Intervention	Hand hygiene education.
Intervention	Experimental	Hand hygiene education and 4 antimicrobial hand towels	Other: Antimicrobial Hand Towel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Antimicrobial Hand Towel	Other	Novel antimicrobial hand towel.	Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Number of participants with respiratory infections		Within 48 hours of enrollment
Number of participants with a subjective fever		Within 48 hours of enrollment

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005334	Fever
D002481	Cellulitis

Ancestor Terms

ID	Term
D001832	Body Temperature Changes
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D012874	Skin Diseases, Infectious

Browse Leaves

Not provided

Browse Branches

Not provided