Feasibility of methylene blue-based combination therapy in the radical treatment of adult
patients with Plasmodium vivax malaria in Ethiopia: a randomised controlled pilot trial
Study rationale:
Elimination has become the goal of malaria programmes in an increasing number of endemic
countries and regions. Primaquine (PQ) is the only registered drug for radical cure of
Plasmodium vivax malaria. Prolonged PQ-based combination therapy carries safety concerns and
resistance to chloroquine (CQ) and PQ is emerging. Methylene blue (MB) has recently been
shown to be safe and effective in the treatment of Plasmodium falciparum malaria in West
Africa. As there is evidence for MB probably being effective against the hypnozoites of
Plasmodium vivax, MB-based drug regimens could be an alternative to PQ-based combination
therapy in Plasmodium vivax malaria.
Study objectives:
The main objective of this trial is to study the feasibility of MB-based combination therapy
in patients with uncomplicated P. vivax malaria in an endemic area of Ethiopia.
Phase:
Phase 2
Details
Lead Sponsor:
Heidelberg University
Collaborators:
Jimma University Ludwig-Maximilians - University of Munich