Pharmacokinetic Evaluation of Artesunate in Infants Being Treated for Severe Malaria - Research Laboratory Addendum to the Observational Study Titled: Safety and Efficacy of Artesunate in Pregnant Women and Infants (< One Month of Age)

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: Newborn
Maximum Age: 1
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Hôpital Cochin Port Royal
RECRUITING
Paris
Contact Information
Primary
Bernadette Tock
btock@fasttrackresearch.com
2404018634
Time Frame
Start Date: 2024-10-06
Estimated Completion Date: 2030-02-28
Participants
Target number of participants: 15
Related Therapeutic Areas
Sponsors
Leads: Amivas Inc.

This content was sourced from clinicaltrials.gov