Trial of Ceramic Water Filters to Reduce Cryptosporidium Infection in Kenya

• Sponsor: Centers for Disease Control and Prevention (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT01695304
• Collaborator: Kenya Medical Research Institute (Other)
• Enrollment: 227
• Location: 1
• Arms: 2
• Duration (Months): 17
• Patients Per Site Per Month: 13.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cryptosporidium; Diarrhea; Cryptosporidiosis; Communicable Diseases; Diarrheal Disease	Other: Ceramic water filter	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 227 participants
• Allocation: Randomized
• Intervention 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.
• 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.
• Study Start Date: Jan 1, 2013
• Actual Primary Completion Date: Aug 1, 2013
• Actual Study Completion Date: Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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.

Outcome Measures

Primary Outcome Measures

1. Longitudinal Diarrhea Prevalence [6 months]

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

2. Health Facility Visits for Diarrheal Disease [6 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Months to 10 Months
• Sexes Eligible for Study: All
• 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.

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Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kemri/Cdc	Kisumu		Kenya

Sponsors and Collaborators

• Centers for Disease Control and Prevention
• Kenya Medical Research Institute

Investigators

• Principal Investigator: Eric Mintz, MD, MPH, Centers for Disease Control and Prevention

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centers for Disease Control and Prevention
• ClinicalTrials.gov Identifier: NCT01695304
• Other Study ID Numbers: CDC-NCEZID-6369; CDCEID10A.1; 2439
• First Posted: Sep 27, 2012
• Last Update Posted: Mar 22, 2017
• Last Verified: Sep 1, 2015

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• 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; Communicable Diseases; Infections; Diarrhea

Study Results

Participant Flow

Arm/Group Title	Intervention Arm	Control Arm
Arm/Group Description	Households with a child 4-10 months old will receive a Cera Maji ceramic water filter for treatment of drinking water. 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.	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.
Period Title: Overall Study
STARTED	120	120
COMPLETED	120	120
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Intervention Arm	Control Arm	Total
Arm/Group Description	Households with a child 4-10 months old will receive a Cera Maji ceramic water filter for treatment of drinking water. 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.	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.	Total of all reporting groups
Overall Participants	120	120	240
Age (months) [Median (Full Range) ]
Median (Full Range) [months]	7	8	7.5
Sex: Female, Male (Count of Participants)
Female	66 55%	62 51.7%	128 53.3%
Male	54 45%	58 48.3%	112 46.7%
Race/Ethnicity, Customized (participants) [Number]
Luo ethnic group	120 100%	120 100%	240 100%
Region of Enrollment (participants) [Number]
Kenya	120 100%	120 100%	240 100%

Outcome Measures

1. Primary Outcome

Title	Longitudinal Diarrhea Prevalence
Description	The primary outcome measure is the longitudinal prevalence of diarrheal disease.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Incidence rate per 100 person-weeks of observation

Arm/Group Title	Intervention Arm	Control Arm
Arm/Group Description	Households with a child 4-10 months old will receive a Cera Maji ceramic water filter for treatment of drinking water. 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.	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.
Measure Participants	115	112
Number [Incidence rate per 100 person-weeks]	7.6	8.9

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Intervention Group	Control Group
Arm/Group Description	Intervention group who received ceramic water filters	Control Group who did not receive ceramic water filters (until after the trial ended)
Measure Participants	115	112
Number [incidence rate per 100 person-weeks]	1.2	2.2

Adverse Events

Time Frame	6 months
Arm/Group Title	Intervention Arm		Control Arm
Arm/Group Description	Households with a child 4-10 months old will receive a Cera Maji ceramic water filter for treatment of drinking water. 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.		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.
All Cause Mortality
	Intervention Arm		Control Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/120 (1.7%)		3/120 (2.5%)
Serious Adverse Events
	Intervention Arm		Control Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/120 (0%)		0/120 (0%)
Other (Not Including Serious) Adverse Events
	Intervention Arm		Control Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/120 (0%)		0/120 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.