Methylene Blue Against Vivax Malaria in Ethiopia

• Status: Withdrawn
• Trial end date: 2018-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Heidelberg University
• Collaborators: Jimma University; Ludwig-Maximilians - University of Munich
• Treatments: Lumefantrine; Methylene Blue; Primaquine

Criteria

Inclusion Criteria:

• Age ≥18 years

• Uncomplicated P. vivax monoinfection (asexual parasite count >250/µl)

• Axillary temperature ≥ 37.5°C or history of fever during last 48 hours

• Ability to tolerate oral drug therapy

• Written informed consent of patient

• Permanent residence in the study area

Exclusion Criteria:

• Therapy with an antimalarial (e.g. CQ, amodiaquine, pyrimethamine-sulfadoxine, quinine, any ACT) or an antibiotic which is effective against malaria parasites (e.g. doxycyclin, clindamycin, CoTrim) during last three weeks

• Mixed malaria infection

• Clinical danger signals (e.g. unable to stand or to sit, unable to drink, repeated vomiting, convulsions) or signs and symptoms of severe malaria (according to WHO definition)

• Known other serious illnesses (e.g. cardiac, renal, hepatic, pulmonary disease, severe malnutrition, severe infectious diseases)

• G6PD deficiency (<60% activity, WHO classification 1-3)

• Patients with known allergy to one or more of the study drugs

• Hemoglobin value <7 g/dL

• Pregnancy or breastfeeding