Trial of Ceramic Water Filters to Reduce Cryptosporidium Infection in Kenya

Cryptosporidiosis Clinical Trial

Official title:

Pilot Intervention Trial of Ceramic Water Filters to Reduce the Burden of Cryptosporidium in Household Drinking Water in Rural Kenya.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01695304
• Other study ID #: CDC-NCEZID-6369
• Secondary ID: CDCEID10A.1
• Status: Not yet recruiting
• Phase: N/A
• First received: September 26, 2012
• Last updated: April 18, 2013
• Start date: February 2013

Study information

• Verified date: April 2013
• Source: Centers for Disease Control and Prevention
• Contact: Ciara O'Reilly, PhD
• Phone: 4046391953
• Email: bwf1[@]cdc.gov
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Centers for Disease Control and PreventionUnited States: Federal GovernmentKenya: Kenya Medical Research Institute Scientific Steering Committee and Ethical Review Committee
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 4 Months to 10 Months

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cryptosporidiosis
• Cryptosporidium
• Diarrheal Disease
• Waterborne Disease

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention	Kenya Medical Research Institute

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Longitudinal diarrhea prevalence	The primary outcome measure is the longitudinal prevalence of diarrheal disease.	6 months	No