NCT01407887

Efficacy and Safety of Artesunate-amodiaquine-methylene for Malaria Treatment in Children

Efficacy and Safety of Artesunate-amodiaquine Combined With Methylene Blue for Falciparum Malaria Treatment in African Children

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Heidelberg University · Academic / Other
• Sex: All
• Age: 6 Months – 59 Months
• Healthy volunteers: Not accepted

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).

Conditions

• Uncomplicated Falciparum Malaria

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2011-08-01
• Primary completion: 2011-08-01
• Completion: 2011-12-01
• First posted: 2011-08-02
• Last updated: 2012-12-05

Locations

1 site across 1 country: Burkina Faso