Trial of Ceramic Water Filters to Reduce Cryptosporidium Infection in Kenya

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2013 by Centers for Disease Control and Prevention
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: April 18, 2013
Last verified: April 2013

September 26, 2012
April 18, 2013
February 2013
August 2013   (final data collection date for primary outcome measure)
Longitudinal diarrhea prevalence [ Time Frame: 6 months ] [ Designated as safety issue: No ]
The primary outcome measure is the longitudinal prevalence of diarrheal disease.
Same as current
Complete list of historical versions of study NCT01695304 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Cryptosporidium
  • Cryptosporidiosis
  • Waterborne Disease
  • 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.
 
Not yet recruiting
240
Not Provided
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.

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Both
4 Months to 10 Months
Yes
Contact: Ciara O'Reilly, PhD 4046391953 bwf1@cdc.gov
Contact: Eric Mintz, MD, MPH 4046393461 edm1@cdc.gov
Kenya
 
NCT01695304
CDC-NCEZID-6369, CDCEID10A.1
No
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
April 2013

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