Communicable Diseases, Cryptosporidiosis, Cryptosporidium; Diarrhea, Diarrheal Disease
Conditions
Keywords
Cryptosporidiosis, Waterborne disease, Diarrheal disease, Ceramic water filters, infants, young children, drinking water, Kenya
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.
Interventions
OTHERCeramic 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.
Sponsors
Kenya Medical Research Institute
Centers for Disease Control and Prevention
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
4 Months to 10 Months
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. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Longitudinal Diarrhea Prevalence | 6 months | The primary outcome measure is the longitudinal prevalence of diarrheal disease. |
| Health Facility Visits for Diarrheal Disease | 6 months | incidence rate of health facility visits for diarrheal disease per 100 person-week of observation |
Countries
Kenya
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Arm 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. | 120 |
| 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. | 120 |
| Total | 240 |
Baseline characteristics
| Characteristic | Intervention Arm | Control Arm | Total |
|---|---|---|---|
| Age, Continuous | 7 months | 8 months | 7.5 months |
| Race/Ethnicity, Customized Luo ethnic group | 120 participants | 120 participants | 240 participants |
| Region of Enrollment Kenya | 120 participants | 120 participants | 240 participants |
| Sex: Female, Male Female | 66 Participants | 62 Participants | 128 Participants |
| Sex: Female, Male Male | 54 Participants | 58 Participants | 112 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 120 | 3 / 120 |
| other Total, other adverse events | 0 / 120 | 0 / 120 |
| serious Total, serious adverse events | 0 / 120 | 0 / 120 |
Outcome results
Primary
Health Facility Visits for Diarrheal Disease
incidence rate of health facility visits for diarrheal disease per 100 person-week of observation
Time frame: 6 months
Population: incidence rate of health facility visits for diarrheal disease per 100 person-week of observation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Arm | Health Facility Visits for Diarrheal Disease | 1.2 incidence rate per 100 person-weeks |
| Control Arm | Health Facility Visits for Diarrheal Disease | 2.2 incidence rate per 100 person-weeks |
Primary
Longitudinal Diarrhea Prevalence
The primary outcome measure is the longitudinal prevalence of diarrheal disease.
Time frame: 6 months
Population: Incidence rate per 100 person-weeks of observation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Arm | Longitudinal Diarrhea Prevalence | 7.6 Incidence rate per 100 person-weeks |
| Control Arm | Longitudinal Diarrhea Prevalence | 8.9 Incidence rate per 100 person-weeks |