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Trial · Interventional

CompletedPhase 2Results postedRegistry data

Methylene Blue Against Falciparum Malaria in Burkina Faso

Short name BlueACTn

NCTNCT02851108 (opens ClinicalTrials.gov in a new tab)Other idUniHD008
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
100 participants (actual)
Sponsor
Heidelberg University · Other
Design
Randomized · Open label (no masking)
Countries
1 country

Burkina Faso

Start
Oct 2016
Primary completion
Dec 2016
Completion
Feb 2017
First posted
1 Aug 2016 (estimated)
Last update posted
25 Mar 2020
Conditions
Malaria, Falciparum

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201620172018
  1. Ph 2

    BlueACTn

    NCT02851108

    Oct 2016 to Feb 2017

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Methylene BlueDrug
  • PrimaquineDrug

Arms2

  • Experimental

    AS-AQ-MB

    Once daily a fixed dose artesunate-amodiaquine formulation combined with once daily methylene blue (15 mg/kg) over a three days period.

  • Active comparator

    AS-AQ-PQ

    Once daily a fixed dose artesunate-amodiaquine over three days combined with a single dose of primaquine on day 2 (0.25 mg/kg).

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in Haemoglobin Compared to the Baseline

    Time frame · 7 days

    Registry description

    Haemoglobin concentrations will be measured in the field using a HemoCue® (HemoCue® AB, Angelholm, Sweden)

Secondary outcomes(4)

  1. Gametocyte Prevalence

    Time frame · 28 days

    Registry description

    measured microscopically at baseline and on day 1, 2, 3, 7, 14, and 28 of follow-up

  2. Adverse Events (AE)

    Time frame · 28 days

    Registry description

    Reports of observed or self-reported adverse event

  3. Mothers/Caretakers Questionnaire on Acceptance

    Time frame · 14 days

    Registry description

    Acceptance of the different treatment regimens by mothers/caretakers

  4. Gametocyte Density

    Time frame · 28 days

    Registry description

    measured microscopically at baseline and on day 1, 2, 3, 7, 14, and 28 of follow-up

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 7 days

Change in Haemoglobin Compared to the Baseline

GroupValue (g/dl)Spread
AS-AQ-MB0.181.42
AS-AQ-PQ0.540.94
Secondary and other outcome results(4)
Secondary outcome· 28 days

Gametocyte Prevalence

GroupValue
Secondary outcome· 28 days

Adverse Events (AE)

GroupValue
Secondary outcome· 14 days

Mothers/Caretakers Questionnaire on Acceptance

GroupValue
Secondary outcome· 28 days

Gametocyte Density

GroupValue

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
AS-AQ-MBOnce daily a fixed dose artesunate-amodiaquine formulation combined with once daily methylene blue (15 mg/kg) over a three days period. Methylene Blue: 50 patients will receive methylene blue–2 / 5033 / 50
AS-AQ-PQOnce daily a fixed dose artesunate-amodiaquine over three days combined with a single dose of primaquine on day 2 (0.25 mg/kg). Primaquine: 50 patients will receive primaquine–0 / 5028 / 50

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

More studies

1 study on this page

Indexing hint: Randomized controlled trial · 2019

Safety and efficacy of artesunate-amodiaquine combined with either methylene blue or primaquine in children with falciparum malaria in Burkina Faso: A randomized controlled trial.

Mendes Jorge et al. 2019PloS onecited by 12

PMID 31600221PMC6786573DOI 10.1371/journal.pone.0222993PUB-31600221

CC BY
Download PDF

Eligibility

Who could join, as posted.

Sex
All
Age
from 6 Months up to 59 Months
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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)

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