Oral Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria Clinical Trial
Official title:
A Phase IIa Proof of Concept Study to Explore the Efficacy, Tolerability and Safety of Fosmidomycin Sodium When Administered With Piperaquine Tetraphosphate to Adults and Older Children With Acute Uncomplicated Plasmodium Falciparum Malaria
The objective of this study is to explore the role of fosmidomycin and piperaquine as
non-artemisinin-based combination therapy for acute uncomplicated Plasmodium falciparum when
administered over three days.
Together, fosmidomycin and piperaquine fulfil the WHO criteria for combination therapy by
meeting the three key parameters of having different modes of action and different
biochemical targets while exhibiting independent blood schizonticidal activity. Like the
artemisinins, fosmidomycin is fast-acting, has an excellent safety record and is active
against existing drug-resistant parasites. Piperaquine has a long half life protecting
fosmidomycin as a much shorter lived molecule against selection of resistant parasites and
will provide post-treatment prophylaxis.
n/a
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment