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

Phase 2

Completed

• Conditions: Malaria
• Interventions: Drug: Artesunate-Amodiaquine (AS-AQ); Drug: Methylenblue-Amodiaquine (MB-AQ); Drug: Methylenblue-Artesunate (MB-AS)

• Registration Number: NCT00545935
• Lead Sponsor: Heidelberg University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07
• Study Completion: 2007-10
• Study First Submitted: 2007-10-16
• Study First Submitted QC: 2007-10-16
• Study First Posted: 2007-10-17
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-02
• Last Update Posted: 2009-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 186

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3-Artesunate-Amodiaquine	Artesunate-Amodiaquine (AS-AQ)	-
1-Methylenblue-Amodiaquine	Methylenblue-Amodiaquine (MB-AQ)	-
2-Methylenblue-Artesunate	Methylenblue-Artesunate (MB-AS)	-

Primary Outcome Measures

Name	Time	Method
Incidence of observed and self-reported non-serious adverse events over the 28 days observation period	28 days

Secondary Outcome Measures

Name	Time	Method
Fever clearance time	28 days
Parasite clearance time	28 days
Early treatment failure (ETF) rate	28 days
Change in haematocrit after 2,14 and 28 days compared to baseline	28 days
MB whole blood concentrations on D3,5 or 7 compared to concentrations after the first dose	28 days
Late clinical failure (LCF) rate at D14 and D28	28 days
Late parasitological failure (LPF) rate at D14 and D28	28 days
Incidence of serious adverse events (SAE) and the adequate clinical and parasitological response rate (ACPR)	28 days

Trial Locations

Locations (1)

Centre de Recherche en Sante de Nouna; 🇧🇫 Nouna, Burkina Faso