Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:11 AM
Study NCT ID:
NCT00699920
Status:
COMPLETED
Last Update Posted:
2010-06-29
First Post:
2008-06-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cohort Study in Uganda Comparing Artesunate + Amiodaquine (Coarsucam) Versus Artemether + Lumenfantrine (Coartem) in the Treatment of Repeated Uncomplicated Plasmodium Falciparum Malaria Attacks
Sponsor:
Sanofi
Organization:
Study Overview
Official Title:
A Randomised Study to Compare a Fixed Dose Combination of Artesunate Plus Amiodaquine (Coarsucam) Versus a Fixed Dose Combination of Artemether Plus Lumefantrine (Coartem) in the Treatment of Repeated Uncomplicated Plasmodium Falciparum Malaria Attacks Occurring During the 2 Years of Follow-up, in Children in Uganda.
Status:
COMPLETED
Status Verified Date:
2010-06
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:
SMART-CURE
Brief Summary:
Primary objective is to demonstrate the non-inferiority of PCR (Polymerase Chain Reaction) adjusted adequate clinical and parasitological response at Day 28 of Coarsucam versus Coartem, based on the first malaria attack of each patient.
Secondary objectives:
For the first attack:
To compare the 2 groups of treatment in terms of:
* Day 42 efficacy
* Parasitological and fever clearance
* Clinical and Biological tolerability
* Evolution of gametocyte carriage
For attack 2nd and following:
To compare the 2 groups of treatment in terms of:
* Day 28 and Day 42 clinical and parasitological effectiveness
* Clinical and Biological tolerability
* Proportion of patients without fever at Day 3
* Proportion of patients without parasites at Day 3
* Evolution of gametocyte carriage
* Compliance
During the total follow up of the cohort:
To compare the 2 groups of treatment in terms of:
* Treatment incidence density
* Impact of repeated treatment on clinical and biological tolerability
* Impact on anaemia
* Impact on Hackett score.
Secondary objectives:
For the first attack:
To compare the 2 groups of treatment in terms of:
* Day 42 efficacy
* Parasitological and fever clearance
* Clinical and Biological tolerability
* Evolution of gametocyte carriage
For attack 2nd and following:
To compare the 2 groups of treatment in terms of:
* Day 28 and Day 42 clinical and parasitological effectiveness
* Clinical and Biological tolerability
* Proportion of patients without fever at Day 3
* Proportion of patients without parasites at Day 3
* Evolution of gametocyte carriage
* Compliance
During the total follow up of the cohort:
To compare the 2 groups of treatment in terms of:
* Treatment incidence density
* Impact of repeated treatment on clinical and biological tolerability
* Impact on anaemia
* Impact on Hackett score.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: