Evaluation of Artesunate in Infants Being Treated for Severe Malaria

NCT06555809 | Recruiting FDA Drug

• 1 other identifier: IVAS-PEDS-PK-1
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

Malaria

Keywords

Artesunate; Infant

Outcome Measures

Primary Outcomes (2)

• 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

  Approximately at 5 minutes, 30 minutes, 90 minutes, and 4 hours after artesunate intravenous injection

• 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

  Approximately at 5 minutes, 30 minutes, 90 minutes, and 4 hours after artesunate intravenous injection

Secondary Outcomes (2)

• Safety, as measured by the number of participants with adverse events

  During standard of care treatment with intravenous artesunate

• Tolerability, as measured by the number of doses of artesunate administered to each participant

  During standard of care treatment with intravenous artesunate

Interventions

Artesunate Injection DRUG

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.

Also known as: Artesunate for Injection

Eligibility Criteria

• Age: 1 Minute - 23 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• Hemoglobin \< 7.0 g/dL at the time when additional blood sample for PK assessment will be drawn as part of standard of care

Sponsors & Collaborators

• Amivas Inc.: lead

Study Sites (1)

Hôpital Cochin Port Royal

Paris, 75014, France

RECRUITING

MeSH Terms

Conditions

Malaria

Interventions

Artesunate; Injections

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Artemisinins; Reactive Oxygen Species; Free Radicals; Inorganic Chemicals; Organic Chemicals; Sesquiterpenes; Terpenes; Hydrocarbons; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Bryan Smith, MD

  Amivas Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bernadette Tock

CONTACT

2404018634; btock@fasttrackresearch.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2024
• First Posted: August 15, 2024
• Study Start: October 6, 2024
• Primary Completion (Estimated): August 31, 2029
• Study Completion (Estimated): February 28, 2030
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)