Study Stopped
Lack of ethical approval in Ethiopia
Methylene Blue Against Vivax Malaria in Ethiopia
BlueAL
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
1 other identifier
interventional
N/A
0 countries
N/A
Brief 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.
Trial Health
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Started Apr 2016
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 2, 2016
CompletedFirst Posted
Study publicly available on registry
March 2, 2016
CompletedStudy Start
First participant enrolled
April 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2018
CompletedMarch 25, 2020
March 1, 2020
1.5 years
February 2, 2016
March 23, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Study feasibility
Patient recruitment rates
180 days
Secondary Outcomes (3)
Incidence of P. vivax
180 days
Adverse events (AE) during total follow-up period
180 days
Study costs
180 days
Study Arms (3)
Artemeter-Lumefantrine (combination therapy)
OTHER33 patients (standard of care)
Artemeter-Lumefantrine and Primaquine (combination therapy)
ACTIVE COMPARATOR33 patients
Artemeter-Lumefantrine and MB (combination therapy)
EXPERIMENTAL33 patients
Interventions
AL first 3 days MB next 14 days
AL first 3 days
AL first 3 days PQ next 14 days
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Heidelberg Universitylead
- Ludwig-Maximilians - University of Munichcollaborator
- Jimma Universitycollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Olaf Müller, Prof. Dr.
Heidelberg University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr.
Study Record Dates
First Submitted
February 2, 2016
First Posted
March 2, 2016
Study Start
April 1, 2016
Primary Completion
October 1, 2017
Study Completion
January 1, 2018
Last Updated
March 25, 2020
Record last verified: 2020-03