Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06555809
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-13
Brief Title:
Evaluation of Artesunate in Infants Being Treated for Severe Malaria
Sponsor:
None
Organization:
None
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 025 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None