Status:
WITHDRAWN
Spatial Repellent Products for the Control of Vector Borne Diseases - Malaria - Kenya
Lead Sponsor:
University of Notre Dame
Collaborating Sponsors:
Centers for Disease Control and Prevention
Kenya Medical Research Institute
Conditions:
Malaria
Eligibility:
All Genders
6-59 years
Phase:
NA
Brief Summary
The primary objective of the study is to demonstrate and quantify the protective efficacy (PE) of spatial repellent products in reducing the incidence of malaria infection in human cohorts. The null h...
Detailed Description
The primary epidemiological endpoint will be the incidence density of first time malaria infections among human cohorts during the follow-up period as detected by polymerase chain reaction assay (PCR)...
Eligibility Criteria
Inclusion
- Children aged 6-59 months
- glucose-6-phosphate dehydrogenase (G6PD) normal (qualitative screen) in sites where P. vivax or P. ovale known prevalence rates represent major burden) and whose treatment with primaquine is implemented within national guidelines
- Hb \> 5mg/dl
- Temperature ≤38.0°C) and no moderate or severe acute illness/infection on the day of inclusion
- Sleeps in cluster \>90% of nights during any given month
- No plans for extended travel (\<1month) outside of home during study
- Not participating in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure during the trial
- Provision of assent/informed consent form signed by the subject and by the parent(s) or another legally acceptable representative
Exclusion
- children \< 6 months or \> 5 years
- G6PD deficiency (qualitative screen) in sites where P. vivax or P. ovale known prevalence rates represent major burden and whose treatment with primaquine is implemented within national guidelines
- Severe anemia
- Febrile illness (temperature ≥38.0°C) or moderate or severe acute illness/infection on the day of inclusion
- Sleeps in cluster \<90% of nights during any given month
- Plans for extended travel (\>1month) outside of home during study
- Participating or planned participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure during the trial
- No provision of assent/informed consent form signed by the subject and by the parent(s) or another legally acceptable representative
Key Trial Info
Start Date :
June 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02294201
Start Date
June 1 2016
End Date
July 1 2016
Last Update
October 6 2016
Active Locations (1)
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1
Kemri-Crc
Kisumu, Kenya