Efficacy and Safety of Artesunate-amodiaquine-methylene for Malaria Treatment in Children

What Was Tested

This registered phase 2 trial tested Methylene blue (non-peptide stack partner).

Design: Mono-centre, two arms, open randomized controlled study in children with uncomplicated falciparum malaria in Burkina Faso.

It had two arms (groups): artesunate, amodiaquine methylene blue (active comparator) and artesunate amodiaquine (no intervention).

Two arms, open randomized controlled study in children with uncomplicated falciparum malaria in Burkina Faso. Intervention: artesunate (AS) - amodiaquine (AQ) - methylene blue (MB) control: artesunate (AS) - amodiaquine (AQ).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 180 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: 6-59 months old children (male and female). Weight ≥ 6kg. Uncomplicated malaria caused by P. falciparum. Asexual parasites ≥ 2 000/µl and ≤ 200 000/µl. Axillary temperature ≥ 37.5°C or a history of fever during last 24 hours.

The full record lists 8 inclusion and 9 exclusion criteria; among the exclusions: severe malaria (who 2000); vomiting (3 or more within 24 hours before the visit); treated in the same trial before.

How the Study Was Run

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

Because people in this Methylene blue (non-peptide stack partner) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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 2011-08 with completion listed for 2011-08.

It ran at 1 site in Burkina Faso.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: P. falciparum gametocyte prevalence (time frame: day 14 of follow-up).

It also tracked 1 secondary outcome, for example P. falciparum gametocyte prevalence and density.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Methylene blue (non-peptide stack partner) in 180 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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