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

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.

Inclusion Criteria:

• 0.5-5 year (6-59 months) old children
• uncomplicated malaria caused by P. falciparum
• asexual parasites ≥ 2000/µ and ≤ 200000/µ
• axillary temperature ≥ 37.5 Celsius or a history of fever during last 24 hours
• Burkinabe nationality
• informed consent

Exclusion Criteria:

• complicated or severe malaria
• any apparent significant disease
• anaemia (haematocrit < 21%)
• treated in the same trial before
• modern antimalarial treatment prior to inclusion (last three days), except children having been treated with chloroquine