Safety and Efficacy of Methylene Blue Combined With Artesunate or Amodiaquine for Malaria Treatment in Children of Burkina Faso: a Pilot Study

What Was Tested

In this phase 2 trial, researchers set out to test Methylene blue (non-peptide stack partner).

The primary objective of this trial is to study the safety of the combination methylene blue (MB)-artesunate (AS) and MB-amodiaquine (AQ) in treating malaria among children compared to the safety of an AS-AQ regimen.

The registry classes the interventions as drug.

More on the Plan

Population: Children aged 6-10 years with uncomplicated malaria from Nouna town.

Sample size: N= 180 (n=60 for each group).

Endpoints: The primary endpoint is the number of adverse events (AE) after drug intake until day 28.

Secondary endpoints are the number of serious adverse events (SAE), adequate clinical and parasitological response (ACPR) rate on day 28, clinical and parasitological failure rates on day 3, 7, 14 and 28, changes in haematocrit until day 28, and fever and parasite clearance time.

Who Took Part

It was open to people of any sex aged from 6 years up to 10 years.

Examples of who could join: 6-10 year old children. Ability to swallow tablets. Uncomplicated malaria caused by P. falciparum. Asexual parasites ≥ 2000/µl and \< 200000/µl. Axillary temperature ≥ 37.5°C.

The full record lists 7 inclusion and 5 exclusion criteria; among the exclusions: complicated or severe malaria; treated in the same trial before; antimalarial treatment prior to inclusion (last three days), except children having been treated with chloroquine.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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.

Nothing was hidden in this open-label Methylene blue (non-peptide stack partner) study: the participants and staff both knew the treatment.

It started in 2006-09 with completion listed for 2006-11.

It ran at 1 site in Burkina Faso.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Incidence of observed and self-reported non-serious adverse events over the 28 days observation period (definition chapter 11).

It also tracked 8 secondary outcomes, for example Incidence of serious adverse events (definition: chapter 11) over the 28 days observation period, ACPR rate until D28, Early treatment failure (ETF) rate, Late clinical failure (LCF) rate at D14 and D28, Late parasitological failure (LPF) rate at D14 and D28 and Fever clearance time.

What This Means in Plain Language

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