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Methylene Blue Against Falciparum Malaria in Burkina Faso (BlueACTn)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02851108
Recruitment Status : Completed
First Posted : August 1, 2016
Results First Posted : March 25, 2020
Last Update Posted : March 25, 2020
Sponsor:
Collaborator:
Centre de Recherche en Sante de Nouna, Burkina Faso
Information provided by (Responsible Party):
Olaf Mueller, Heidelberg University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Malaria, Falciparum Drug: Methylene Blue Drug: Primaquine Phase 2

Detailed Description:

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. The secondary objective of this study is: To study the efficacy of this MB-based triple combination in comparison with standard ACT-PQ in the treatment of uncomplicated falciparum malaria in young African children.

It is a mono-center, open randomised controlled non-inferiority study in children with uncomplicated falciparum malaria in Burkina Faso. Patients will be randomised to two treatment groups (arms):

  1. AS-AQ-MB
  2. AS-AQ-PQ

Study population: Children aged 6-59 months with uncomplicated falciparum malaria from Nouna Hospital in north-western Burkina Faso.

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

Treatment: The group AS-AQ-MB will receive once daily a fixed dose AS-AQ formulation combined with once daily MB (15 mg/kg) over a three days period. The control group will receive once daily a fixed dose AS-AQ over three days combined with a single dose of PQ on day 2 (0.25 mg/kg).

Endpoints: Primary endpoint is the haemoglobin value on day 7 compared to baseline. Secondary endpoints are adverse events (AE), adequate clinical and parasitological response (ACPR) rate (PCR-corrected for recrudescences), as well as gametocyte prevalence and density.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety of Artesunate-amodiaquine Combined With Methylene Blue or Primaquine for Falciparum Malaria Treatment in African Children: A Randomised Controlled Trial
Actual Study Start Date : October 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arm Intervention/treatment
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.
Drug: Methylene Blue
50 patients will receive methylene blue
Other Name: 3,7-bis(Dimethylamino)-phenothiazine-5-ium chloride

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).
Drug: Primaquine
50 patients will receive primaquine
Other Name: (±)-N4-(6-Methoxychinolin-8-yl)pentan-1,4-diamine




Primary Outcome Measures :
  1. Change in Haemoglobin Compared to the Baseline [ Time Frame: 7 days ]
    Haemoglobin concentrations will be measured in the field using a HemoCue® (HemoCue® AB, Angelholm, Sweden)


Secondary Outcome Measures :
  1. Gametocyte Prevalence [ Time Frame: 28 days ]
    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 ]
    Reports of observed or self-reported adverse event

  3. Mothers/Caretakers Questionnaire on Acceptance [ Time Frame: 14 days ]
    Acceptance of the different treatment regimens by mothers/caretakers

  4. Gametocyte Density [ Time Frame: 28 days ]
    measured microscopically at baseline and on day 1, 2, 3, 7, 14, and 28 of follow-up



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02851108


Locations
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Burkina Faso
CRSN
Nouna, Burkina Faso
Sponsors and Collaborators
Heidelberg University
Centre de Recherche en Sante de Nouna, Burkina Faso
Investigators
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Principal Investigator: Olaf Müller, Prof. Dr. Heidelberg University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Olaf Mueller, Prof. Dr., Heidelberg University
ClinicalTrials.gov Identifier: NCT02851108    
Other Study ID Numbers: UniHD008
First Posted: August 1, 2016    Key Record Dates
Results First Posted: March 25, 2020
Last Update Posted: March 25, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Olaf Mueller, Heidelberg University:
falciparum malaria
sub saharan
africa
elimination disorder
Additional relevant MeSH terms:
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Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Primaquine
Phenothiazine
Methylene Blue
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action