Actively Recruiting
Evaluation of Artesunate in Infants Being Treated for Severe Malaria
Led by Amivas Inc. · Updated on 2024-12-10
15
Participants Needed
1
Research Sites
281 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is essentially a laboratory study that is an addendum to an ongoing prospective Phase 4 multicenter observational study titled: "Safety and Efficacy of Artesunate in Pregnant Women and Infants (ARTEMUM)" being conducted in France. Infants, the parents of whom provided consent to have data collected from their child as part of the ARTEMUM study, will have an additional blood sample collected when other standard of care blood specimens are collected during the 2-day period after the start of intravenous (IV) artesunate treatment. A maximum of 4 samples will be taken and plasma will be isolated and stored frozen until analysis for plasma artesunate and dihydroartemisinin (DHA) concentrations. Red blood cells will also be frozen for further analysis (for example Kelch-13 mutations). In addition, a standard of care blood sample will be collected approximately one month post treatment for clinical laboratory tests.
CONDITIONS
Official Title
Evaluation of Artesunate in Infants Being Treated for Severe Malaria
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Parental consent provided to the ARTEMUM Study
- Parental consent provided to participate in this PK Laboratory Study
- Infants younger than 2 years of age with malaria confirmed by PCR, thin or thick smear, or rapid diagnostic test
- Treated with at least one dose of intravenous artesunate
You will not qualify if you...
- Hemoglobin less than 7.0 g/dL at the time of additional blood sample collection for pharmacokinetic assessment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Hôpital Cochin Port Royal
Paris, France, 75014
Actively Recruiting
Research Team
B
Bernadette Tock
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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