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

Heidelberg University

Status and phase: Completed; Phase 2

Conditions: Malaria

Treatments: Drug: Methylenblue-Amodiaquine (MB-AQ); Drug: Methylenblue-Artesunate (MB-AS); Drug: Artesunate-Amodiaquine (AS-AQ)

Study type: Interventional

Funder types: Other

Identifiers

NCT00545935

MB-2007b

Details and patient eligibility

About

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.

Sex: All

Ages: 6 to 59 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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186 participants in 3 patient groups

1-Methylenblue-Amodiaquine

Active Comparator group

Treatment:

Drug: Methylenblue-Amodiaquine (MB-AQ)

2-Methylenblue-Artesunate

Active Comparator group

Treatment:

Drug: Methylenblue-Artesunate (MB-AS)

3-Artesunate-Amodiaquine

Active Comparator group

Treatment:

Drug: Artesunate-Amodiaquine (AS-AQ)