Efficacy and Safety of Artesunate-amodiaquine-methylene for Malaria Treatment in Children
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|ClinicalTrials.gov Identifier: NCT01407887|
Recruitment Status : Completed
First Posted : August 2, 2011
Last Update Posted : December 5, 2012
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).
|Condition or disease||Intervention/treatment||Phase|
|Uncomplicated Falciparum Malaria||Drug: artesunate (AS) - amodiaquine (AQ) - methylene blue (MB)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy and Safety of Artesunate-amodiaquine Combined With Methylene Blue for Falciparum Malaria Treatment in African Children|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||August 2011|
|Actual Study Completion Date :||December 2011|
Active Comparator: artesunate, amodiaquine methylene blue
two arms, open randomized controlled study in children with uncomplicated falciparum malaria in Burkina Faso. Intervention: artesunate (AS) - amodiaquine (AQ) - methylene blue (MB) control: artesunate (AS) - amodiaquine (AQ)
Drug: artesunate (AS) - amodiaquine (AQ) - methylene blue (MB)
The group AS-AQ-MB will receive once daily a fixed dose AS-AQ formulation combined with once daily MB over a three days period.
No Intervention: artesunate amodiaquine
The control group will receive once daily a fixed dose AS-AQ over three days.
- P. falciparum gametocyte prevalence [ Time Frame: day 14 of follow-up ]P. falciparum gametocyte prevalence on day 14 of follow-up (PCR determination)
- P. falciparum gametocyte prevalence and density [ Time Frame: day 1, 2, 3, 7, and 28 of follow-up ]P. falciparum gametocyte prevalence and density on day 1, 2, 3, 7, and 28 of follow-up (PCR determination) P. falciparum gametocyte prevalence and density on day 1, 2, 3, 7, and 28 of follow-up (microscopic determination)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01407887
|Nouna Health District|
|Nouna, Mouhoun, Burkina Faso, P.O. Box 34|
|Principal Investigator:||Olaf Müller, Prof Dr||Institut of Public health, University of heidelberg|