NCT00545935

Safety and Efficacy of Methylene Blue Combined With Amodiaquine or Artesunate for Malaria Treatment in Children of Burkina Faso

Safety and Efficacy of Methylene Blue Combined With Amodiaquine or Artesunate for Malaria Treatment in Children of Burkina Faso: RCT in the Frame of the A8 Project of SFB 544

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 186 (planned)
• Sponsor: Heidelberg University · Academic / Other
• Sex: All
• Age: 6 Months – 59 Months
• Healthy volunteers: —

Summary

The purpose of the study is to investigate the safety and efficacy profile of a new paediatric MB formulation combined with AQ or AS and compared to AS-AQ in young African children with uncomplicated falciparum malaria.

Conditions

• Malaria

Interventions

Type	Name	Description
DRUG	Methylenblue-Amodiaquine (MB-AQ)	For 3 days twice daily 10 mg/kg MB accompanied by once daily 10 mg/kg AQ
DRUG	Methylenblue-Artesunate (MB-AS)	3 days once daily 4 mg/kg AS accompanied by twice daily 10 mg/kg MB given over 7 days
DRUG	Artesunate-Amodiaquine (AS-AQ)	For 3 days once daily 10 mg/kg AQ accompanied by 4mg/kg AS.

Timeline

• Start date: 2007-07-01
• Completion: 2007-10-01
• First posted: 2007-10-17
• Last updated: 2009-02-03

Locations

1 site across 1 country: Burkina Faso