Evaluating Artesunate Treatment in Infants with Severe Malaria
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)
Amivas Inc. · NCT06555809
This study is testing how safe and effective artesunate treatment is for infants under 2 years old with severe malaria by collecting blood samples during their first two days of treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 15 (estimated) |
| Ages | 1 Minute to 23 Months |
| Sex | All |
| Sponsor | Amivas Inc. (industry) |
| Locations | 1 site (Paris) |
| Trial ID | NCT06555809 on ClinicalTrials.gov |
What this trial studies
This observational study is an addendum to the ARTEMUM study, focusing on infants under 2 years old receiving intravenous artesunate for severe malaria. Parents who consented to the ARTEMUM study will allow additional blood samples to be collected during the first 48 hours of treatment for pharmacokinetic analysis. Up to four blood samples will be taken to measure plasma concentrations of artesunate and dihydroartemisinin, along with standard care samples collected one month post-treatment. The study aims to gather data on the safety and efficacy of artesunate in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates are infants under 2 years of age diagnosed with malaria and whose parents have consented to participate in the ARTEMUM study.
Not a fit: Patients with hemoglobin levels below 7.0 g/dL at the time of blood sample collection will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of artesunate's pharmacokinetics in infants, leading to improved treatment protocols for severe malaria.
How similar studies have performed: While this study builds on existing research, it focuses specifically on infants, which may provide novel insights into artesunate treatment in this age group.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Paris
- Hôpital Cochin Port Royal — Paris, France (RECRUITING)
Study contacts
- Principal investigator: Bryan Smith, MD — Amivas Inc.
- Study coordinator: Bernadette Tock
- Email: btock@fasttrackresearch.com
- Phone: 2404018634
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Malaria, Artesunate, Infant