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Methylene Blue Against Vivax Malaria in Ethiopia

NCT02696928 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2020-03-25

No results posted yet for this study

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.

Conditions

  • Vivax Malaria

Interventions

DRUG

Artemeter-Lumefantrine and MB (combination therapy)

AL first 3 days MB next 14 days

DRUG

Artemeter-Lumefantrine (combination therapy)

AL first 3 days

DRUG

Artemeter-Lumefantrine and Primaquine (combination therapy)

AL first 3 days PQ next 14 days

Sponsors & Collaborators

  • Ludwig-Maximilians - University of Munich

    collaborator OTHER

  • Jimma University

    collaborator OTHER

  • Heidelberg University

    lead OTHER

Principal Investigators

  • Olaf Müller, Prof. Dr. · Heidelberg University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2017-10-31
Completion
2018-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02696928 on ClinicalTrials.gov