Methylene Blue Against Falciparum Malaria in Burkina Faso

• Status: Completed
• Trial end date: 2017-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Safety of artesunate-amodiaquine combined with methylene blue or primaquine for falciparum malaria treatment in African children: A randomised controlled trial

Elimination has become the goal of malaria programmes in an increasing number of endemic countries and regions. As resistance against artemisinin compounds has recently started to emerge in South-East Asia, there is a clear need to develop alternative malaria drug combinations. Adding another anti-malarial with a short half-life such as methylene blue to standard ACT (artemisinin-based combination therapy) could be a strategy to prevent artemisinin resistance development. Moreover, adding a gametocytocidal drug to ACT reduces the probability of transmission of P. falciparum parasites including drug-resistant parasites.

Objectives: The primary objective of this trial is to investigate the safety of artesunate (AS) - amodiaquine (AQ) - methylene blue (MB) compared to AS - AQ - primaquine (PQ) in young children with uncomplicated falciparum malaria in Burkina Faso.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Heidelberg University
• Collaborator: Centre de Recherche en Sante de Nouna, Burkina Faso
• Treatments: Amodiaquine; Artesunate; Methylene Blue; Phenothiazine; Primaquine

Criteria

Inclusion Criteria:

• Weight ≥ 6 kg

• Uncomplicated malaria caused by P. falciparum

• Asexual parasites ≥ 2 000/µl and ≤ 100 000/µl

• Axillary temperature ≥ 37.5°C or a history of fever during the last 24 hours

• Burkinabe nationality

• Permanent residence in the study area with no intention of leaving during the surveillance period

• Written informed consent of parents or care takers

Exclusion Criteria:

• Severe malaria

• Mixed malaria infection

• Vomiting (>2 times within 24 hours before the visit)

• Any apparent significant disease, including severe malnutrition

• A history of a previous, significant adverse reaction or known allergy to one or more of the study drugs

• Anaemia (haemoglobin < 7 g/dl)

• Treated in the same trial before

• All modern antimalarial treatment prior to inclusion (last seven days)

• Therapy with serotonin reuptake inhibitors (e.g. citalopram, escitalopram, fluoxetine, Paroxetine, Sertraline)

• Simultaneous participation in another investigational study

• Patients with known HIV/AIDS disease

• Therapy with drugs known to inhibit the liver enzymes cytochrome 2A6 (e.g. methoxsalen, pilocarpine, tranylcypromine) and/or cytochrome 2C8 (e.g. trimethoprim, ketoconazole, ritonavir, saquinavir, lopinavir, gemfibrozil, montelukast)