Clinical Trial: Methylene Blue Against Vivax Malaria in Ethiopia

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Feasibility of Methylene Blue-based Combination Therapy in the Radical Treatment of Adult Patients With Plasmodium Vivax Malaria in Ethiopia: a Randomised Controlled Pilot

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.


Detailed Summary:

The specific aims are (1) to test the feasibility and costs of methods and procedures for later use of MB-based combination therapy on a large scale, (2) to assess the safety of MB-based combination therapy, (3) to estimate the efficacy of MB-based combination therapy against malaria relapse, (4) to study the community acceptance of MB-based combination therapy, and (5) to strengthen the local capacity for malaria research and control in Jimma/Ethiopia.

Study design:

The study is designed as a pilot trial in adult patients with uncomplicated P. vivax malaria in Jimma, Ethiopia. Patients will be randomised to three treatment groups:

  1. Arthemeter/Lumefantrine (AL)
  2. AL-PQ, and
  3. AL-MB. Follow-up will be over a period of 6 months.

Study population:

Adult patients with uncomplicated P. vivax malaria (age ≥18 years) in Jimma/Ethiopia (G6PD deficient subjects are excluded) will become enrolled in the outpatient departments of the study centres. The sample size will be 33 per study arm, a total of 99 patients.

Study treatments:

  • AL standard treatments twice daily (total of 80 mg/dose A plus 480 mg/dose L) over first three study days
  • PQ 15 mg once daily for 14 days
  • MB 780 mg once daily for 14 days Treatments will be 100% directly observed.

Study outcomes:

Outcome parameters
Sponsor: Heidelberg University

Current Primary Outcome: Study feasibility [ Time Frame: 180 days ]

Patient recruitment rates


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Incidence of P. vivax [ Time Frame: 180 days ]
    Passive and active surveillance
  • Adverse events (AE) during total follow-up period [ Time Frame: 180 days ]
    Passive and active surveillance
  • Study costs [ Time Frame: 180 days ]
    Costs per patient


Original Secondary Outcome: Same as current

Information By: Heidelberg University

Dates:
Date Received: February 2, 2016
Date Started: April 2016
Date Completion: January 2018
Last Updated: March 3, 2016
Last Verified: February 2016