MalariaNCT06555809
Evaluation of Artesunate in Infants Being Treated for Severe Malaria
An observational study of Malaria, run by Amivas Inc. at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 minute to 23 months
- Conditions the study is for
- Malaria
- What is being tested?
- Artesunate Injection
- Type of treatment
- Injection or infusion
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 6 Oct 2024to 28 Feb 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 minute to 23 months
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Cochin Port Royal
Paris, 75014
Caroline Charlier-Woerther, 01 58 41 41 11, caroline.charlier@aphp.fr
About this study
Official title: Pharmacokinetic Evaluation of Artesunate in Infants Being Treated for Severe Malaria - Research Laboratory Addendum to the Observational Study Titled: Safety and Efficacy of Artesunate in Pregnant Women and Infants (< One Month of Age)
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.
Read the detailed description
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
- Malaria
- Being tested
- Artesunate Injection
- Keywords
- Artesunate, Infant
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artesunate InjectionDrug
Also called Artesunate for 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Safety, as measured by the number of participants with adverse events
Measured: During standard of care treatment with intravenous artesunate
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
Measured: During standard of care treatment with intravenous artesunate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start6 Oct 2024
- Primary completion31 Aug 2029 (estimated)
- Study completion28 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amivas Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bryan Smith, MD, Principal investigator, Amivas Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06555809
- Sponsor's protocol ID
- IVAS-PEDS-PK-1
- Status last verified
- Dec 2024
- First submitted
- 13 Aug 2024
- Last updated
- 10 Dec 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Evaluation of Artesunate in Infants Being Treated for Severe Malaria - Research Laboratory Addendum to the Observational Study Titled: Safety and Efficacy of Artesunate in Pregnant Women and Infants (< One Month of Age)
- ClinicalTrials.gov ID
- NCT06555809
- Acronym / sponsor ID
- IVAS-PEDS-PK-1
- Conditions
- Malaria
- Keywords
- Artesunate, Infant
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Amivas Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Oct 2024 (actual)
- Primary completion
- 31 Aug 2029 (estimated)
- Study completion
- 28 Feb 2030 (estimated)
- First posted
- 15 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 minute to 23 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Hemoglobin < 7.0 g/dL at the time when additional blood sample for PK assessment will be drawn as part of standard of care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Artesunate InjectionAlso: Artesunate for InjectionAdditional 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. | Drug | – |
Primary outcome
Change in concentration of artesunate in blood plasma samples
Time frame: Approximately at 5 minutes, 30 minutes, 90 minutes, and 4 hours after artesunate intravenous injection
Change in concentration of artesunate in blood plasma samples collected as part of standard of care
Change in concentration of dihydroartemisinin in blood plasma samples
Time frame: Approximately at 5 minutes, 30 minutes, 90 minutes, and 4 hours after artesunate intravenous injection
Change in concentration of dihydroartemisinin in blood plasma samples collected as part of standard of care
2 secondary outcomes
Safety, as measured by the number of participants with adverse events
Time frame: During standard of care treatment with intravenous artesunate
Tolerability, as measured by the number of doses of artesunate administered to each participant
Time frame: During standard of care treatment with intravenous artesunate
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bryan Smith, MD principal investigator
Amivas Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malaria, run by Amivas Inc. at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bernadette Tock (2404018634, btock@fasttrackresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in concentration of artesunate in blood plasma samples (time frame: Approximately at 5 minutes, 30 minutes, 90 minutes, and 4 hours after artesunate intravenous injection). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024.