Ignite Creation Date:
2024-05-05 @ 11:44 PM
Last Modification Date:
2024-10-26 @ 10:39 AM
Study NCT ID:
NCT01407887
Status:
COMPLETED
Last Update Posted:
2012-12-05
First Post:
2011-08-01
Brief Title:
Efficacy and Safety of Artesunate-amodiaquine-methylene for Malaria Treatment in Children
Sponsor:
Heidelberg University
Organization:
Heidelberg University
Study Overview
Official Title:
Efficacy and Safety of Artesunate-amodiaquine Combined With Methylene Blue for Falciparum Malaria Treatment in African Children
Status:
COMPLETED
Status Verified Date:
2011-06
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:
None
Brief Summary:
Title Efficacy and safety of artesunate-amodiaquine combined with methylene blue for falciparum malaria treatment in African children randomised controlled trial
Design Mono-centre two arms open randomized controlled study in children with uncomplicated falciparum malaria in Burkina Faso
Phase Phase II
Objectives The primary objective of this trial is to study the efficacy and safety of the triple therapy artesunate AS - amodiaquine AQ - methylene blue MB given over three days in young children with uncomplicated falciparum malaria in Burkina Faso compared to the local standard three days artemisinin-based combination therapy ACT AS-AQ regimen
Population Children aged 6-59 months with uncomplicated falciparum malaria from Nouna Hospital in north-western Burkina Faso
Sample size 180 patients 90 per study arm
Design Mono-centre two arms open randomized controlled study in children with uncomplicated falciparum malaria in Burkina Faso
Phase Phase II
Objectives The primary objective of this trial is to study the efficacy and safety of the triple therapy artesunate AS - amodiaquine AQ - methylene blue MB given over three days in young children with uncomplicated falciparum malaria in Burkina Faso compared to the local standard three days artemisinin-based combination therapy ACT AS-AQ regimen
Population Children aged 6-59 months with uncomplicated falciparum malaria from Nouna Hospital in north-western Burkina Faso
Sample size 180 patients 90 per study arm
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