Methylene Blue Against Falciparum Malaria in Burkina Faso
Condition: Malaria, Falciparum
MeSH terms: Malaria; Malaria, Falciparum
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      The overall goal of the underlying research project is to develop a MB-based first-line drug
      combination regimen against uncomplicated falciparum malaria in SSA.

      The primary objective of this study is: To study the safety of the triple combination
      AS-AQ-MB compared to AS-AQ-PQ in the treatment of uncomplicated falciparum malaria in young
      African children. The secondary objective of this study is: To study the efficacy of this
      MB-based triple combination in comparison with standard ACT-PQ in the treatment of
      uncomplicated falciparum malaria in young African children.

      It is a mono-center, open randomised controlled non-inferiority study in children with
      uncomplicated falciparum malaria in Burkina Faso. Patients will be randomised to two
      treatment groups (arms):

        1. AS-AQ-MB

        2. AS-AQ-PQ

      Study population: Children aged 6-59 months with uncomplicated falciparum malaria from Nouna
      Hospital in north-western Burkina Faso.

      Sample size: 100 patients (50 per study arm).

      Treatment: The group AS-AQ-MB will receive once daily a fixed dose AS-AQ formulation combined
      with once daily MB (15 mg/kg) over a three days period. The control group will receive once
      daily a fixed dose AS-AQ over three days combined with a single dose of PQ on day 2 (0.25
      mg/kg).

      Endpoints: Primary endpoint is the haemoglobin value on day 7 compared to baseline. Secondary
      endpoints are adverse events (AE), adequate clinical and parasitological response (ACPR) rate
      (PCR-corrected for recrudescences), as well as gametocyte prevalence and density.
    

Intervention name(s): Methylene Blue; Primaquine
Intervention type(s): Drug; Drug
Intervention description(s): 50 patients will receive methylene blue; 50 patients will receive primaquine
Other intervention name(s): 3,7-bis(Dimethylamino)-phenothiazine-5-ium chloride; (±)-N4-(6-Methoxychinolin-8-yl)pentan-1,4-diamine
Intervention MeSH terms: Primaquine; Phenothiazine; Methylene Blue
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: falciparum malaria; sub saharan; africa; elimination disorder