Methylene Blue Against Falciparum Malaria in Burkina Faso

What Was Tested

The trial (phase 2) is built around Methylene blue (non-peptide stack partner).

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.

It had two arms (groups): AS-AQ-MB (experimental) and AS-AQ-PQ (active comparator).

The registry classes the interventions as drug.

More on the Plan

The overall goal of the underlying research project is to develop a MB-based first-line drug combination regimen against uncomplicated falciparum malaria in SSA.

The primary objective of this study is: To study the safety of the triple combination AS-AQ-MB compared to AS-AQ-PQ in the treatment of uncomplicated falciparum malaria in young African children.

Patients will be randomised to two treatment groups (arms): 1.

Sample size: 100 patients (50 per study arm).

Who Took Part

Enrollment: 100 actual participants took part.

It was open to people of any sex aged from 6 months up to 59 months.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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. Permanent residence in the study area with no intention of leaving during the surveillance period.

The full record lists 7 inclusion and 12 exclusion criteria; among the exclusions: severe malaria; mixed malaria infection; vomiting (\>2 times within 24 hours before the visit).

How the Study Was Run

Design: randomized, parallel-group and open-label.

The participants were allocated by chance, so the Methylene blue (non-peptide stack partner) group and the comparison group should start out alike.

The Methylene blue (non-peptide stack partner) group and the comparison group ran side by side rather than switching.

Everyone knew when Methylene blue (non-peptide stack partner) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2016-10 with completion listed for 2016-12.

It ran at 1 site in Burkina Faso.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in Haemoglobin Compared to the Baseline (time frame: 7 days).

It also tracked 4 secondary outcomes, for example Gametocyte Prevalence, Adverse Events (AE), Mothers/Caretakers Questionnaire on Acceptance and Gametocyte Density.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Methylene blue (non-peptide stack partner) in 100 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Methylene blue (non-peptide stack partner) compound page, all human trials.