Methylene Blue Against Falciparum Malaria in Burkina Faso
Condition: Malaria, Falciparum
MeSH terms: Malaria; Malaria, Falciparum
Intervention: Methylene Blue; Primaquine
Intervention description: 50 patients will receive methylene blue; 50 patients will receive primaquine
Intervention MeSH terms: Primaquine; Phenothiazine; Methylene Blue
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 6 Months
Maximum age: 59 Months
Healthy volunteers: No
Keywords: falciparum malaria; sub saharan; africa; elimination disorder

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.
    

Eligibility 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)