NCT06555809 Evaluation of Artesunate in Infants Being Treated for Severe Malaria
| NCT ID | NCT06555809 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Amivas Inc. |
| Condition | Malaria |
| Study Type | OBSERVATIONAL |
| Enrollment | 15 participants |
| Start Date | 2024-10-06 |
| Primary Completion | 2029-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 15 participants in total. It began in 2024-10-06 with a primary completion date of 2029-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 (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 Criteria
Inclusion Criteria: * 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 Criteria: * Hemoglobin \< 7.0 g/dL at the time when additional blood sample for PK assessment will be drawn as part of standard of care
Contact & Investigator
Bryan Smith, MD
PRINCIPAL INVESTIGATOR
Amivas Inc.
Frequently Asked Questions
Who can join the NCT06555809 clinical trial?
This trial is open to participants of all sexes, aged 1 Minute or older, up to 23 Months, studying Malaria. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06555809 currently recruiting?
Yes, NCT06555809 is actively recruiting participants. Contact the research team at btock@fasttrackresearch.com for enrollment information.
Where is the NCT06555809 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT06555809 clinical trial?
NCT06555809 is sponsored by Amivas Inc.. The principal investigator is Bryan Smith, MD at Amivas Inc.. The trial plans to enroll 15 participants.