Malaria, Falciparum Clinical Trial
Official title:
Safety of Artesunate-amodiaquine Combined With Methylene Blue or Primaquine for Falciparum Malaria Treatment in African Children: A Randomised Controlled Trial
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.
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.
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