Trial of Ceramic Water Filters to Reduce Cryptosporidium Infection in Kenya

NCT01695304 | Completed Results

• 3 other identifiers: CDC-NCEZID-6369CDCEID10A.12439
• Study Type: interventional
• Target: 227
• Locations: 1 country
• Sites: 1

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.

Conditions

Cryptosporidium; Diarrhea; Cryptosporidiosis; Communicable Diseases; Diarrheal Disease

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Longitudinal Diarrhea Prevalence

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

  6 months

• Health Facility Visits for Diarrheal Disease

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

  6 months

Study Arms (2)

Intervention Arm

EXPERIMENTAL

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

Control Arm

NO INTERVENTION

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.

Interventions

Ceramic water filter OTHER

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.

Also known as: Cera Maji ceramic water filter

Intervention Arm

Eligibility Criteria

• Age: 4 Months - 10 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

Sponsors & Collaborators

• Centers for Disease Control and Prevention: lead
• Kenya Medical Research Institute: collaborator

Study Sites (1)

Kemri/Cdc

Kisumu, Kenya

Location

MeSH Terms

Conditions

Diarrhea; Cryptosporidiosis; Communicable Diseases; Waterborne Diseases

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Intestinal Diseases, Parasitic; Parasitic Diseases; Infections; Protozoan Infections, Animal; Parasitic Diseases, Animal; Coccidiosis; Protozoan Infections; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Animal Diseases; Disease Attributes; Pathologic Processes

Results Point of Contact

• Title: Ciara O'Reilly, PhD
• Organization: Centers for Disease Control and Prevention

bwf1@cdc.gov

404-639-1953

Study Officials

• Eric Mintz, MD, MPH

  Centers for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2012
• First Posted: September 27, 2012
• Study Start: January 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: June 1, 2014
• Last Updated: March 22, 2017
• Results First Posted: March 22, 2017

Record last verified: 2015-09

Data Sharing

• IPD Sharing: Will share

Locations

KE (1)