Trial of Ceramic Water Filters to Reduce Cryptosporidium Infection in Kenya
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Cryptosporidium Cryptosporidiosis Waterborne Disease Diarrheal Disease |
Other: Ceramic water filter |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Pilot Intervention Trial of Ceramic Water Filters to Reduce the Burden of Cryptosporidium in Household Drinking Water in Rural Kenya. |
- Longitudinal diarrhea prevalence [ Time Frame: 6 months ] [ Designated as safety issue: No ]The primary outcome measure is the longitudinal prevalence of diarrheal disease.
| Estimated Enrollment: | 240 |
| Study Start Date: | February 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Intervention Arm
Households with a child 4-10 months old will receive a Cera Maji ceramic water filter for treatment of drinking water.
|
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
|
|
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.
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 4 Months to 10 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
-
Contacts and Locations| Contact: Ciara O'Reilly, PhD | 4046391953 | bwf1@cdc.gov |
| Contact: Eric Mintz, MD, MPH | 4046393461 | edm1@cdc.gov |
| Kenya | |
| Not yet recruiting | |
| Kisumu, Kenya | |
| Principal Investigator: Richard Omore, MPH | |
| Sub-Investigator: Benjamin Ochieng, MSc | |
| Sub-Investigator: Peter Jaron | |
| Principal Investigator: | Eric Mintz, MD, MPH | Centers for Disease Control and Prevention |
More Information
No publications provided
| Responsible Party: | Centers for Disease Control and Prevention |
| ClinicalTrials.gov Identifier: | NCT01695304 History of Changes |
| Other Study ID Numbers: | CDC-NCEZID-6369, CDCEID10A.1 |
| Study First Received: | September 26, 2012 |
| Last Updated: | April 18, 2013 |
| Health Authority: | United States: Institutional Review Board United States: Centers for Disease Control and Prevention United States: Federal Government Kenya: Kenya Medical Research Institute Scientific Steering Committee and Ethical Review Committee |
Keywords provided by Centers for Disease Control and Prevention:
|
Cryptosporidiosis Waterborne disease Diarrheal disease Ceramic water filters |
infants young children drinking water Kenya |
Additional relevant MeSH terms:
|
Cryptosporidiosis Diarrhea Intestinal Diseases, Parasitic Parasitic Diseases Protozoan Infections, Animal Parasitic Diseases, Animal Coccidiosis |
Protozoan Infections Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases Signs and Symptoms, Digestive Signs and Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013