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

• Status: Completed
• Trial end date: 2006-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this trial is to study the safety of the combination methylene blue (MB)-artesunate (AS) and MB-amodiaquine (AQ) in treating malaria among children compared to the safety of an AS-AQ regimen. The secondary objective is to investigate the efficacy of MB-AS and MB-AQ.

• Phase: Phase 2

Details

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

Criteria

Inclusion criteria:

• 6-10 year old children

• Ability to swallow tablets

• Uncomplicated malaria caused by P. falciparum

• Asexual parasites ≥ 2000/µl and < 200000/µl

• Axillary temperature ≥ 37.5°C

• Burkinabe nationality

• Informed consent

Exclusion Criteria:

• Complicated or severe malaria

• Any apparent significant disease

• Anaemia (haematocrit < 21%)

• Treated in the same trial before

• Antimalarial treatment prior to inclusion (last three days), except children having been treated with chloroquine