Ignite Creation Date:
2024-05-06 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 2:31 PM
Study NCT ID:
NCT05343312
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-12-08
First Post:
2022-04-18
Brief Title:
In Vivo Efficacy of Artemether-Lumefantrine Amodiaquine-Artesunate Dihydroartemisinin-Piperaquine and Pironaridine-Artesunate in Mozambique
Sponsor:
Centro de Investigacao em Saude de Manhica
Organization:
Centro de Investigacao em Saude de Manhica
Study Overview
Official Title:
Monitoring the Therapeutic Efficacy of the Combinations Artemether-Lumefantrine Amodiaquine-Artesunate Dihydroartemisinin-Piperaquine and Pironaridine-Artesunate in the Treatment of Uncomplicated Plasmodium Falciparum Malaria in Children Under 5 Years of Age in Five Sentinel Sites in Mozambique
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MEFI_IV
Brief Summary:
This is a classical in vivo clinical trial following World Health organizations recommendations ran as a multisite study within Mozambique trying to assess the efficacy and safety in 5 sites of the four oral ACTS artemether-lumefantrine AL Amodiaquine-Artesunate AQ-AS Dihydroartemisinin-Piperaquine DHP and Pironaridine-Artesunate for the treatment of uncomplicated malaria in children aged5 years
Detailed Description:
Eligible patients were consecutively assigned to the cohort and treated with AL cohort 1 AQ-AS cohort 2 DHP cohort 3 and PA cohort 4 AL Coartem will be administered twice daily for three days six doses in total with dosage determined according to body weight one tablet 20mg artemether and 120mg lumefantrine for children 5 to 15kg two tablets per dose for those 15 to 25kg and three tablets per dose for those 25 to 35kg AQ-AS Winthrop will be administered once daily according to body weight one 25mg artesunate and 675mg amodiaquine tablet in children 9kg one 50mg artesunate and 135mg amodiaquine tablet in children 9-179kg and one 100mg artesunate and 270mg amodiaquine tablet in children 18-35kg DHP will be administered once daily according to body weight half tablet 40mg dihydroartemisinin e 320 mg piperaquine for children 5 to 10Kg one tablet for per dose for those 10 20Kg and 2 tablets for 20 or more Kg PA granules 60mg pirinaridine 20mg artesunate will administered once daily according to body weight 1 granule per dose for children 5 to 8Kg two for children 8 15Kg three for those 15 20Kg PA 180mg pyrinaridine60 mg artesunate one tablet for children 20 24Kg and two tablets for those 24 45Kg All treatments will be directly observed for a minimum of 30 minutes Vomiting occurring within the first 30 minutes implied the repetition of the full dose of treatment For those patients living far away from the health facilities and for which direct observation of the evening doses of AL was challenging admission was offered for the first three days of the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None