Phase 2 Efficacy Study of Primaquine and Methylene Blue

What Was Tested

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

The primary outcome measure will be the proportion of mosquitoes infected pre and post-treatment, assessed through membrane feeding and measured by oocyst prevalence in mosquitoes dissected on day 7 post feed.

It had four arms (groups): SP-AQ only (active comparator), SP-AQ plus PQ (experimental), DP only (active comparator) and DP plus MB (experimental).

Participants in this arm will be treated with dihydroartemisinin-piperaquine (DP), which will be administered once a day for three days.

The registry classes the interventions as drug.

More on the Plan

Protocol will be shared on request.

Who Took Part

80 actual participants took part.

It was open to men only aged from 5 years up to 50 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Glucose-6-phosphate dehydrogenase (G6PD) normal defined by CareStart™ G6PD rapid diagnostic test (RDT) or the OSMMR2000 G6PD semi-qualitative test. Presence of P. falciparum gametocytes on thick blood film at a density \>30 gametocytes/µL (i.e. ≥2 gametocytes recorded in the thick film against 500 white blood cells). No allergies to study drugs. Individuals weighing \<80 kg. No evidence of severe or chronic disease.

The full record lists 9 inclusion and 8 exclusion criteria; among the exclusions: age \< 5 years or \> 50 years; female gender; previous reaction to study drugs/known allergy to study drugs.

How the Study Was Run

It was run as a randomized, parallel-group and single-blind study.

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.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Only one side, usually the participants, was kept unaware of whether Methylene blue (non-peptide stack partner) was given.

Those kept unaware of assignments: outcomes assessor.

It started in 2016-07 with completion listed for 2017-01.

It ran at 1 site in Mali.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Mosquito infectivity assessed through membrane feeding assays (time frame: 7 day).

It also tracked 16 secondary outcomes, for example Gametocyte prevalence, density, and sex ratio measured microscopically and by molecular methods, Asexual parasite prevalence and density, Safety measurements including hemoglobin and signs of hemolysis, Peak plasma concentration (Cmax) of primaquine, Area under the concentration curve (AUC) of primaquine and Elimination half life (t1/2) of primaquine.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Methylene blue (non-peptide stack partner) in 80 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.