Evaluation of Artesunate in Infants Being Treated for Severe Malaria
ConditionMalaria
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-23
SponsorAmivas Inc.
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Hemoglobin < 7.0 g/dL at the time when additional blood sample for PK assessment will be drawn as part of standard of care
Trial population
Infants \< 2 years of age with malaria (positive blood by PCR or thin or thick smear or RDT treated with at least 1 dose of intravenous artesunate with hemoglobin (Hb) levels ≥ 7.0 g/dL.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Artesunate Injection
DrugAdditional 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Change in concentration of artesunate in blood plasma samples
Change in concentration of artesunate in blood plasma samples collected as part of standard of care
Time frame
Approximately at 5 minutes, 30 minutes, 90 minutes, and 4 hours after artesunate intravenous injection2
Change in concentration of dihydroartemisinin in blood plasma samples
Change in concentration of dihydroartemisinin in blood plasma samples collected as part of standard of care
Time frame
Approximately at 5 minutes, 30 minutes, 90 minutes, and 4 hours after artesunate intravenous injectionSecondary outcomes
1
Safety, as measured by the number of participants with adverse events
Safety, as measured by the number of participants with adverse events
Time frame
During standard of care treatment with intravenous artesunate2
Tolerability, as measured by the number of doses of artesunate administered to each participant
Tolerability of artesunate treatment, as measured by the number of doses of artesunate administered to each participant
Time frame
During standard of care treatment with intravenous artesunateSponsors and contacts
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Source ClinicalTrials.gov