Status:
RECRUITING
Evaluation of Artesunate in Infants Being Treated for Severe Malaria
Lead Sponsor:
Amivas Inc.
Conditions:
Malaria
Eligibility:
All Genders
1-23 years
Brief 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 (A...
Detailed Description
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 (A...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Hemoglobin \< 7.0 g/dL at the time when additional blood sample for PK assessment will be drawn as part of standard of care
Key Trial Info
Start Date :
October 6 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 28 2030
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06555809
Start Date
October 6 2024
End Date
February 28 2030
Last Update
December 10 2024
Active Locations (1)
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1
Hôpital Cochin Port Royal
Paris, France, 75014