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Evaluation of Novel Antimicrobial Hand Towels

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ClinicalTrials.gov Identifier: NCT02512614
Recruitment Status : Completed
First Posted : July 31, 2015
Last Update Posted : July 31, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Diarrheal Diseases Acute Respiratory Infections Fever Skin Infection Other: Antimicrobial Hand Towel Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 449 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation of Novel Antimicrobial Hand Towels
Study Start Date : March 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Number of participants with respiratory infections [ Time Frame: Within 48 hours of enrollment ]
  2. Number of participants with a subjective fever [ Time Frame: Within 48 hours of enrollment ]
  3. Number of participants with a skin infection [ Time Frame: Within 48 hours of enrollment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

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Responsible Party: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT02512614     History of Changes
Other Study ID Numbers: CDC-NCEZID-6102
First Posted: July 31, 2015    Key Record Dates
Last Update Posted: July 31, 2015
Last Verified: July 2015
Additional relevant MeSH terms:
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Anti-Bacterial Agents
Anti-Infective Agents
Infection
Communicable Diseases
Respiratory Tract Infections
Cellulitis
Skin Diseases, Infectious
Respiratory Tract Diseases
Suppuration
Connective Tissue Diseases
Inflammation
Pathologic Processes
Skin Diseases