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Evaluation of Artesunate in Infants Being Treated for Severe Malaria

NCT06555809 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 15

Last updated 2024-12-10

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Artesunate Injection

Additional blood sample will be collected when other standard of care blood specimens are collected during the 2-day period after the start of intravenous artesunate treatment.

Sponsors & Collaborators

  • Amivas Inc.

    lead INDUSTRY

Principal Investigators

  • Bryan Smith, MD · Amivas Inc.

Eligibility

Min Age
1 Minute
Max Age
23 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-06
Primary Completion
2029-08-31
Completion
2030-02-28
FDA Drug
Yes

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06555809 on ClinicalTrials.gov