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Trial of Ceramic Water Filters to Reduce Cryptosporidium Infection in Kenya

Primary Purpose

Cryptosporidium; Diarrhea, Cryptosporidiosis, Communicable Diseases

Status

Completed

Phase

Not Applicable

Locations

Kenya

Study Type

Interventional

Intervention

Ceramic water filter

About this trial

This is an interventional prevention trial for Cryptosporidium; Diarrhea focused on measuring Cryptosporidiosis, Waterborne disease, Diarrheal disease, Ceramic water filters, infants, young children, drinking water, Kenya

Eligibility Criteria

4 Months - 10 Months (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Kemri/Cdc

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Arm

Control Arm

Arm Description

Households with a child 4-10 months old will receive a Cera Maji ceramic water filter for treatment of drinking water.

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.

Outcomes

Primary Outcome Measures

Longitudinal Diarrhea Prevalence

The primary outcome measure is the longitudinal prevalence of diarrheal disease.

Health Facility Visits for Diarrheal Disease

incidence rate of health facility visits for diarrheal disease per 100 person-week of observation

Secondary Outcome Measures

Full Information

NCT ID

NCT01695304

First Posted

September 26, 2012

Last Updated

February 1, 2017

Sponsor

Centers for Disease Control and Prevention

Collaborators

Kenya Medical Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT01695304

Brief Title

Trial of Ceramic Water Filters to Reduce Cryptosporidium Infection in Kenya

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2015

Overall Recruitment Status

Completed

Study Start Date

January 2013 (undefined)

Primary Completion Date

August 2013 (Actual)

Study Completion Date

June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centers for Disease Control and Prevention

Collaborators

Kenya Medical Research Institute

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cryptosporidium; Diarrhea, Cryptosporidiosis, Communicable Diseases, Diarrheal Disease

Keywords

Cryptosporidiosis, Waterborne disease, Diarrheal disease, Ceramic water filters, infants, young children, drinking water, Kenya

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

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.

Allocation

Randomized

Enrollment

227 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention Arm

Arm Type

Experimental

Arm Description

Households with a child 4-10 months old will receive a Cera Maji ceramic water filter for treatment of drinking water.

Arm Title

Control Arm

Arm Type

No Intervention

Arm Description

Intervention Type

Other

Intervention Name(s)

Ceramic water filter

Other Intervention Name(s)

Cera Maji ceramic water filter

Intervention Description

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.

Primary Outcome Measure Information:

Title

Longitudinal Diarrhea Prevalence

Description

The primary outcome measure is the longitudinal prevalence of diarrheal disease.

Time Frame

6 months

Title

Health Facility Visits for Diarrheal Disease

Description

incidence rate of health facility visits for diarrheal disease per 100 person-week of observation

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

4 Months

Maximum Age & Unit of Time

10 Months

Accepts Healthy Volunteers

Eligibility Criteria

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. -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eric Mintz, MD, MPH

Organizational Affiliation

Centers for Disease Control and Prevention

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kemri/Cdc

City

Kisumu

Country

Kenya

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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.

Learn more about this trial

Trial of Ceramic Water Filters to Reduce Cryptosporidium Infection in Kenya

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