Trial Outcomes & Findings for Trial of Ceramic Water Filters to Reduce Cryptosporidium Infection in Kenya (NCT NCT01695304)
NCT ID: NCT01695304
Last Updated: 2017-03-22
Results Overview
The primary outcome measure is the longitudinal prevalence of diarrheal disease.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
227 participants
Primary outcome timeframe
6 months
Results posted on
2017-03-22
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
120
|
120
|
|
Overall Study
COMPLETED
|
120
|
120
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial of Ceramic Water Filters to Reduce Cryptosporidium Infection in Kenya
Baseline characteristics by cohort
| Measure |
Intervention Arm
n=120 Participants
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.
|
Control Arm
n=120 Participants
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
n=240 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
7 months
n=5 Participants
|
8 months
n=7 Participants
|
7.5 months
n=5 Participants
|
|
Sex: Female, Male
Female
|
66 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Luo ethnic group
|
120 participants
n=5 Participants
|
120 participants
n=7 Participants
|
240 participants
n=5 Participants
|
|
Region of Enrollment
Kenya
|
120 participants
n=5 Participants
|
120 participants
n=7 Participants
|
240 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Incidence rate per 100 person-weeks of observation
The primary outcome measure is the longitudinal prevalence of diarrheal disease.
Outcome measures
| Measure |
Intervention Arm
n=115 Participants
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.
|
Control Arm
n=112 Participants
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.
|
|---|---|---|
|
Longitudinal Diarrhea Prevalence
|
7.6 Incidence rate per 100 person-weeks
|
8.9 Incidence rate per 100 person-weeks
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: incidence rate of health facility visits for diarrheal disease per 100 person-week of observation
incidence rate of health facility visits for diarrheal disease per 100 person-week of observation
Outcome measures
| Measure |
Intervention Arm
n=115 Participants
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.
|
Control Arm
n=112 Participants
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.
|
|---|---|---|
|
Health Facility Visits for Diarrheal Disease
|
1.2 incidence rate per 100 person-weeks
|
2.2 incidence rate per 100 person-weeks
|
Adverse Events
Intervention Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Control Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Ciara O'Reilly, PhD
Centers for Disease Control and Prevention
Phone: 404-639-1953
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place