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Methylene Blue Against Falciparum Malaria in Burkina Faso

NCT02851108 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-03-25

Study results available
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Summary

Safety of artesunate-amodiaquine combined with methylene blue or primaquine for falciparum malaria treatment in African children: A randomised controlled trial

Elimination has become the goal of malaria programmes in an increasing number of endemic countries and regions. As resistance against artemisinin compounds has recently started to emerge in South-East Asia, there is a clear need to develop alternative malaria drug combinations. Adding another anti-malarial with a short half-life such as methylene blue to standard ACT (artemisinin-based combination therapy) could be a strategy to prevent artemisinin resistance development. Moreover, adding a gametocytocidal drug to ACT reduces the probability of transmission of P. falciparum parasites including drug-resistant parasites.

Objectives: The primary objective of this trial is to investigate the safety of artesunate (AS) - amodiaquine (AQ) - methylene blue (MB) compared to AS - AQ - primaquine (PQ) in young children with uncomplicated falciparum malaria in Burkina Faso.

Conditions

  • Malaria, Falciparum

Interventions

DRUG

Methylene Blue

50 patients will receive methylene blue

DRUG

Primaquine

50 patients will receive primaquine

Sponsors & Collaborators

  • Centre de Recherche en Sante de Nouna, Burkina Faso

    collaborator OTHER_GOV

  • 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
6 Months
Max Age
59 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2016-12-31
Completion
2017-02-28

Countries

  • Burkina Faso

Study Locations

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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 NCT02851108 on ClinicalTrials.gov