Evaluation of Artesunate in Infants Being Treated for Severe Malaria
Recruiting now
Conditions studied: Malaria
In brief
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.
Key facts
- Study ID
- NCT06555809
- Run by
- Amivas Inc.
- People needed
- 15
- Starts
- 2024-10-06
- Expected to finish
- 2030-02-28
- Last updated by the study team
- 2024-12-10
Who can join
Age: any, up to 2. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Parental consent provided to the ARTEMUM Study
- Parental consent provided to participate in this PK Laboratory Study
- Infants < 2 years of age with malaria (positive blood by polymerase chain reaction (PCR) or thin or thick smear or rapid diagnostic test (RDT), or any combination of those) treated by at least 1 dose of intravenous artesunate
You may not qualify if…
- Hemoglobin < 7.0 g/dL at the time when additional blood sample for PK assessment will be drawn as part of standard of care
Where it is running
- Hôpital Cochin Port Royal — Paris, France (enrolling)
Full record on ClinicalTrials.gov
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