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

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2

Details

• Lead Sponsor: Heidelberg University
• Treatments: Amodiaquine; Artemisinins; Artesunate; Methylene Blue

Criteria

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