Phase 2
N=100
Methylene Blue Against Falciparum Malaria in Burkina Faso
Malaria, Falciparum
Bottom Line
View on ClinicalTrials.gov: NCT02851108 ↗Enrolled (actual)
100
Serious AEs
2.0%
Results posted
Mar 2020
Primary outcome: Primary: Change in Haemoglobin Compared to the Baseline — 0.18; 0.54 g/dl
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Methylene Blue (Drug); Primaquine (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Heidelberg University
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Haemoglobin Compared to the Baseline |
0.18; 0.54 | — |
| SECONDARY Gametocyte Prevalence |
— | — |
| SECONDARY Adverse Events (AE) |
— | — |
| SECONDARY Mothers/Caretakers Questionnaire on Acceptance |
— | — |
| SECONDARY Gametocyte Density |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- Weight ≥ 6 kg
- Uncomplicated malaria caused by P. falciparum
- Asexual parasites ≥ 2 000/µl and ≤ 100 000/µl
- Axillary temperature ≥ 37.5°C or a history of fever during the last 24 hours
- Burkinabe nationality
- Permanent residence in the study area with no intention of leaving during the surveillance period
- Written informed consent of parents or care takers
Exclusion Criteria
- Severe malaria
- Mixed malaria infection
- Vomiting (>2 times within 24 hours before the visit)
- Any apparent significant disease, including severe malnutrition
- A history of a previous, significant adverse reaction or known allergy to one or more of the study drugs
- Anaemia (haemoglobin < 7 g/dl)
- Treated in the same trial before
- All modern antimalarial treatment prior to inclusion (last seven days)
- Therapy with serotonin reuptake inhibitors (e.g. citalopram, escitalopram, fluoxetine, Paroxetine, Sertraline)
- Simultaneous participation in another investigational study
- Patients with known HIV/AIDS disease
- Therapy with drugs known to inhibit the liver enzymes cytochrome 2A6 (e.g. methoxsalen, pilocarpine, tranylcypromine) and/or cytochrome 2C8 (e.g. trimethoprim, ketoconazole, ritonavir, saquinavir, lopinavir, gemfibrozil, montelukast)
Data sourced from ClinicalTrials.gov (NCT02851108). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.