Status:
COMPLETED
Spatial Repellents for the Prevention of Malaria in Kenya
Lead Sponsor:
University of Notre Dame
Collaborating Sponsors:
S.C. Johnson & Son, Inc.
Kenya Medical Research Institute
Conditions:
Malaria
Eligibility:
All Genders
6-10 years
Phase:
NA
Brief Summary
Spatial repellents are chemical-based devices that when placed in a room, make that room non-conducive for mosquitoes. These tools can be used to help in the fight against vector borne diseases such a...
Detailed Description
Spatial repellents (SRs) have been widely used for the prevention of mosquito bites but their protective efficacy (PE) in reducing mosquito-borne diseases has never been evaluated in Africa. To addres...
Eligibility Criteria
Inclusion
- Children aged 6 months to \<10 years
- Hb \> 5mg/dl
- 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 informed consent form signed by the parent(s) or guardian
- Children not on regular malaria prophylaxis° such as Proguanil
- Willingness to take AL and no history of hypersensitivity to AL
Exclusion
- Children \< 6 months or ≥ 10 years
- Hb ≤ 5 mg/dL, or Hb \< 6mg/dL with signs of clinical decompensation
- 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 informed consent form signed by the parent(s) or guardian
- Children on regular malaria prophylaxis° such as Proguanil
- Unwillingness or refusal to take AL and history of AL hypersensitivity
- Other malaria prophylaxis medicines: Mefloquine, Atavaquone/Proguanil (Malarone), Doxycycline, Tafenoquine, Sulfadoxine-Pyrimethamine (Fansidar), Amodiaquine and Co-trimoxazole (Septrin)
Key Trial Info
Start Date :
March 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 9 2023
Estimated Enrollment :
5984 Patients enrolled
Trial Details
Trial ID
NCT04766879
Start Date
March 2 2021
End Date
December 9 2023
Last Update
April 15 2024
Active Locations (2)
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1
Centers for Disease Control and Prevention
Busia, Busia County, Kenya
2
Kenya Medical Research Institute (KEMRI)
Busia, Busia County, Kenya