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.

Study Overview

• Status: Completed
• Conditions: Malaria
• Intervention / Treatment: Drug: Methylenblue-Amodiaquine (MB-AQ); Drug: Methylenblue-Artesunate (MB-AS); Drug: Artesunate-Amodiaquine (AS-AQ)

• Study Type: Interventional
• Enrollment: 186
• Phase: Phase 2

Contacts and Locations

Study Locations

• Burkina Faso
  • Nouna, Burkina Faso
    • Centre de Recherche en Sante de Nouna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 4 years (Child)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1-Methylenblue-Amodiaquine	Drug: Methylenblue-Amodiaquine (MB-AQ); For 3 days twice daily 10 mg/kg MB accompanied by once daily 10 mg/kg AQ
Active Comparator: 2-Methylenblue-Artesunate	Drug: Methylenblue-Artesunate (MB-AS); 3 days once daily 4 mg/kg AS accompanied by twice daily 10 mg/kg MB given over 7 days
Active Comparator: 3-Artesunate-Amodiaquine	Drug: Artesunate-Amodiaquine (AS-AQ); For 3 days once daily 10 mg/kg AQ accompanied by 4mg/kg AS.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of observed and self-reported non-serious adverse events over the 28 days observation period	28 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of serious adverse events (SAE) and the adequate clinical and parasitological response rate (ACPR)	28 days
Early treatment failure (ETF) rate	28 days
Late clinical failure (LCF) rate at D14 and D28	28 days
Late parasitological failure (LPF) rate at D14 and D28	28 days
Fever clearance time	28 days
Parasite clearance time	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

Collaborators and Investigators

• Sponsor: Heidelberg University
• Investigators: Principal Investigator: Olaf Mueller, Prof., Heidelberg University

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Study Completion: October 1, 2007

Study Registration Dates

• First Submitted: October 16, 2007
• First Submitted That Met QC Criteria: October 16, 2007
• First Posted (Estimate): October 17, 2007

Study Record Updates

• Last Update Posted (Estimate): February 3, 2009
• Last Update Submitted That Met QC Criteria: February 2, 2009
• Last Verified: February 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Vector Borne Diseases; Parasitic Diseases; Protozoan Infections; Malaria; Anti-Infective Agents; Antiviral Agents; Antineoplastic Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Anthelmintics; Schistosomicides; Antiplatyhelmintic Agents; Artesunate; Amodiaquine
• Other Study ID Numbers: MB-2007b