Actively Recruiting
Pharmacokinetic Evaluation of Artesunate in Infants Being Treated for Severe Malaria Research Laboratory Addendum to the Observational Study: Safety and Efficacy of Artesunate in Pregnant Women and Infants
Led by Amivas Inc. · Updated on 2024-12-10
15
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research focuses on infants under 2 years old being treated for severe malaria. It is an add-on laboratory study to a larger ongoing observational study called ARTEMUM, which examines the safety and effectiveness of artesunate in pregnant women and infants. The study aims to measure the levels of artesunate and its active form, dihydroartemisinin (DHA), in the blood of infants receiving treatment, following World Health Organization recommendations for safety and relapse monitoring. Infants who are already part of the ARTEMUM study and receiving intravenous artesunate treatment will have up to four additional blood samples collected within the first 48 hours of treatment. These samples will be taken alongside standard care blood draws to measure artesunate and DHA concentrations. A further blood sample will be collected about one month after treatment for clinical laboratory tests. The collected plasma and red blood cells will be frozen for detailed analysis, including testing for specific mutations. Participants will be monitored during routine care, with blood samples timed to best capture drug levels shortly after dosing. Researchers will track changes in artesunate and DHA levels in plasma, as well as safety and tolerability by recording any adverse events and the number of doses given. Laboratory test results and clinical data will be gathered from the main ARTEMUM study forms. The total participation period includes initial treatment and follow-up approximately one month later.
CONDITIONS
Brief 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 under 2 years of age with malaria confirmed by PCR, blood smear, or rapid diagnostic test
- Treatment with at least one dose of intravenous artesunate
You will not qualify if you...
- Hemoglobin level less than 7.0 g/dL at the time of additional blood sample collection for pharmacokinetic assessment
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Consent is obtained from parents for participation in this study and the ARTEMUM study.
Duration - 2 days
Participants receive intravenous artesunate as part of standard care for severe malaria. Additional blood samples are collected alongside standard care samples for pharmacokinetic evaluation during the first 48 hours after treatment starts.
Up to 4 blood sample collections during the 2-day intravenous artesunate treatment period.
Duration - Approximately 1 month after treatment
Participants have a follow-up blood sample collected approximately one month after treatment to assess clinical laboratory tests for safety and relapse monitoring.
1 follow-up blood sample collection visit approximately one month post treatment.
Trial Site Locations
Total: 1 location
1
Hôpital Cochin Port Royal
Paris, France, 75014
Actively Recruiting
Research Team
B
Bernadette Tock
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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