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Trial of Ceramic Water Filters to Reduce Cryptosporidium Infection in Kenya

This study has been completed.
Sponsor:
Collaborator:
Kenya Medical Research Institute
Information provided by (Responsible Party):
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT01695304
First received: September 26, 2012
Last updated: February 1, 2017
Last verified: September 2015
September 26, 2012
February 1, 2017
January 2013
August 2013   (Final data collection date for primary outcome measure)
  • Longitudinal Diarrhea Prevalence [ Time Frame: 6 months ]
    The primary outcome measure is the longitudinal prevalence of diarrheal disease.
  • Health Facility Visits for Diarrheal Disease [ Time Frame: 6 months ]
    incidence rate of health facility visits for diarrheal disease per 100 person-week of observation
Longitudinal Diarrhea Prevalence [ Time Frame: 6 months ]
The primary outcome measure is the longitudinal prevalence of diarrheal disease.
Complete list of historical versions of study NCT01695304 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Trial of Ceramic Water Filters to Reduce Cryptosporidium Infection in Kenya
Pilot Intervention Trial of Ceramic Water Filters to Reduce the Burden of Cryptosporidium in Household Drinking Water in Rural Kenya.
The aim of the study is to examine the efficacy of ceramic water filters to reduce the burden of waterborne diarrheal illness among infants in selected villages in Kenya. In Kenya very young children are given drinking water or water is used in reconstitution of their food. We hypothesize that ceramic water filters will remove Cryptosporidium from drinking water reducing infection in infants.
Diarrhea is a major cause of illness among children in Africa. Cryptosporidium is a protozoan waterborne diarrheal pathogen resistant to chlorine. Ceramic filters are effective at improving drinking water quality, including removal of protozoa. In a recent preliminary analysis of >22,000 children <5 years enrolled in the Global Enterics Multi-Center Study (GEMS) case-control study of moderate-to-severe diarrhea, Cryptosporidium was identified as a leading cause of diarrhea in infants across all four participating African sites. This pilot is the first Cryptosporidium specific intervention trial of household ceramic water filters to reduce the burden of cryptosporidiosis acquired through drinking water in rural Kenya.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Masking Description:
This is an intervention trial of ceramic water filters, and as such cannot be masked. The intervention participants received the CWFs during the trial and the control group after the trial was over.
Primary Purpose: Prevention
  • Cryptosporidium; Diarrhea
  • Cryptosporidiosis
  • Communicable Diseases
  • Diarrheal Disease
Other: Ceramic water filter
In total, 120 households with a child 4-10 months old will receive a Cera Maji ceramic water filter for treatment of drinking water at initial entry into the study (intervention group), and 120 households with a child 4-10 months old at initial entry into the study will not receive a ceramic water filter (control group). The study duration will be 6 months. All households in the control group will receive a Cera Maji ceramic water filter when the study ends.
Other Name: Cera Maji ceramic water filter
  • Experimental: Intervention Arm
    Households with a child 4-10 months old will receive a Cera Maji ceramic water filter for treatment of drinking water.
    Intervention: Other: Ceramic water filter
  • No Intervention: Control Arm
    Households with a child 4-10 months old at initial entry into the study will not receive a ceramic water filter (control group). The study duration will be 6 months. All households in the control group will receive a Cera Maji ceramic water filter when the study ends.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
227
June 2014
August 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

Children 4-10 months old living in selected villages in the Asembo Health and Demographic Surveillance System (HDSS) study area in Kenya whose primary caretakers consent on their behalf to be visited weekly for 6 months to carry out weekly illness surveillance, and have a follow up home visit one year after initial enrollment into the trial. The household in which the child resides must be a consenting participant in the HDSS. As the children included in the trial are infants, the child's primary caretaker will be invited to participate and be administered questionnaires. Random selection will be at the compound level. Only one household per compound will be eligible for selection.

Exclusion Criteria:

Children 4-10 months old whose households are not active consenting participants in the HDSS will not be eligible for inclusion. Only the subset of children 4-10 months old who are randomly selected in the sample will be eligible for participation.

Sexes Eligible for Study: All
4 Months to 10 Months   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Kenya
 
 
NCT01695304
CDC-NCEZID-6369
CDCEID10A.1 ( Other Identifier: Centers for Disease Control and Prevention )
2439 ( Other Identifier: Kenya Medical Research Institute )
No
Not Provided
Yes
No PII will be shared with any researcher. It is possible that researchers may request access to the clean de-identified data once closed out for all aspects of the work.
Centers for Disease Control and Prevention
Centers for Disease Control and Prevention
Kenya Medical Research Institute
Principal Investigator: Eric Mintz, MD, MPH Centers for Disease Control and Prevention
Centers for Disease Control and Prevention
September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP