Status:
COMPLETED
Spatial Repellents for Vector Control
Lead Sponsor:
University of Notre Dame
Collaborating Sponsors:
S.C. Johnson & Son, Inc.
fhiClinical
Conditions:
Malaria
Eligibility:
All Genders
6-10 years
Phase:
NA
Brief Summary
The primary objective of the study is to demonstrate and quantify the protective efficacy of a single Spatial Repellent (SR) product, in reducing malaria infection in a human cohort. The study design ...
Detailed Description
Children ≥ 6 months to \< 10 years of age will be enrolled in a single cohort across 60 clusters (30 clusters per treatment arm). The cohort will be followed for 6 months for baseline covariate measur...
Eligibility Criteria
Inclusion
- Children ≥ 6 months to \< 10 years of age
- Children with Hb \> 7 g/dL and no signs of known chronic disease or other other serious illness
- Sleeps in cluster ≥ 90% of nights during any given month
- Not participating in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure during the trial
- Provision of informed consent (and/or assent) form (ICF) signed by the parent(s) or guardian
Exclusion
- Children \< 6 months or ≥ 10 years
- Childrend with Hb \<= 7 g/dL with signs of known chronic disease or other serious illness, or Hb \<6 g/dL with signs of clinical decompensation
- Sleeps in cluster \<90% of nights during any given month
- Participating or planned participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure during the trial
- No provision of ICF (and/or assent) signed by the parent(s) or guardian
Key Trial Info
Start Date :
July 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 2 2024
Estimated Enrollment :
1911 Patients enrolled
Trial Details
Trial ID
NCT04795648
Start Date
July 8 2021
End Date
March 2 2024
Last Update
April 2 2024
Active Locations (2)
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1
Catholic Relief Services
Bamako, Mali
2
Malaria Research and Training Center (MRTC), University of Bamako, Mali
Bamako, Mali