Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00336375
Status:
COMPLETED
Last Update Posted:
2007-11-01
First Post:
2006-06-12
Brief Title:
Treatment of Uncomplicated Childhood Malaria in Tanzania by ArtemetherLumefantrine - Efficacy and Genotyping
Sponsor:
Karolinska University Hospital
Organization:
Karolinska University Hospital
Study Overview
Official Title:
Treatment of Uncomplicated Childhood Malaria by an Artemisinin Derivative in Combination With Lumefantrine Efficacy Safety and Genotyping
Status:
COMPLETED
Status Verified Date:
2007-10
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:
None
Brief Summary:
The purpose of this explorative clinical trial is to study parasite population dynamics diversity and clearance kinetics of Plasmodium falciparum as well as determination of the molecular mechanisms associated with drug resistance during the early phase of artemether-lumefantrine treatment when the drug intake is either accompanied with or without intake of fatty food The hypothesis is that intake of fatty food together with artemether-lumefantrine will enhance parasite clearance and thereby decrease the risk of early selection of genetic markers related to drug resistance The study population is children aged 1-10 years with uncomplicated malaria in Bagamoyo District Tanzania Enrolled children will be randomly allocated to either intake of a fatty meal or not together with the study drug Artemether-lumefantrine will be given twice daily for 3 days in standard doses according to bodyweight Study participants will be admitted during the study period 3 daysto allow close supervision and detailed blood sampling
Detailed Description:
None
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