Evaluation of Artesunate in Infants Being Treated for Severe Malaria

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-06

Study Completion Date

2030-02-28

Brief Summary

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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.

Detailed Description

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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. Parents of infants under 2 years of age who provided consent to participate in the ARTEMUM study will be asked to provide consent for their child to this laboratory study providing the infant was eligible for the ARTEMUM study. During the first 48 hours after the start of IV artesunate treatment, a maximum of 4 samples of blood will be collected when other standard of care samples are being collected. With regard to blood collected for standard of care, it is recognized that samples between 0.25 and 5 hours post doses will be the most useful for pharmacokinetic (PK) analysis due to the 30-to-45-minute half-life of DHA. Plasma will be isolated and frozen until submission to the central laboratory for artesunate and DHA plasma concentrations. In addition, a standard of care blood sample will be collected approximately one month post treatment for clinical laboratory tests. The recommendation by the World Health Organization (WHO) is followed in France not only for safety (anemia) but also for relapse. Clinical laboratory test results and other data to be included in the analysis will be abstracted from the case report forms (CRFs) from the ARTEMUM study.

Conditions

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Malaria

Keywords

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Artesunate Infant

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Artesunate for Injection

Eligibility Criteria

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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

Minimum Eligible Age

1 Minute

Maximum Eligible Age

23 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bryan Smith, MD

Role: PRINCIPAL_INVESTIGATOR

Amivas Inc.

Locations

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Hôpital Cochin Port Royal

Paris, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Bernadette Tock

Role: CONTACT

Phone: 2404018634

Email: [email protected]

Facility Contacts

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Caroline Charlier-Woerther

Role: primary

Other Identifiers

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IVAS-PEDS-PK-1

Identifier Type: -

Identifier Source: org_study_id