Evaluating Artesunate Treatment in Infants with Severe Malaria

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.