Efficacy and Safety of Artesunate-amodiaquine-methylene for Malaria Treatment in Children
NCT ID: NCT01407887
Last Updated: 2012-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
180 participants
INTERVENTIONAL
2011-08-31
2011-12-31
Brief Summary
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Design: Mono-centre, two arms, open randomized controlled study in children with uncomplicated falciparum malaria in Burkina Faso.
Phase: Phase II.
Objectives: The primary objective of this trial is to study the efficacy and safety of the triple therapy artesunate (AS) - amodiaquine (AQ) - methylene blue (MB) given over three days in young children with uncomplicated falciparum malaria in Burkina Faso compared to the local standard three days artemisinin-based combination therapy (ACT) AS-AQ regimen.
Population: Children aged 6-59 months with uncomplicated falciparum malaria from Nouna Hospital in north-western Burkina Faso.
Sample size: 180 patients (90 per study arm).
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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artesunate, amodiaquine methylene blue
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)
artesunate (AS) - amodiaquine (AQ) - methylene blue (MB)
The group AS-AQ-MB will receive once daily a fixed dose AS-AQ formulation combined with once daily MB over a three days period.
artesunate amodiaquine
The control group will receive once daily a fixed dose AS-AQ over three days.
No interventions assigned to this group
Interventions
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artesunate (AS) - amodiaquine (AQ) - methylene blue (MB)
The group AS-AQ-MB will receive once daily a fixed dose AS-AQ formulation combined with once daily MB over a three days period.
Eligibility Criteria
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Inclusion Criteria
* 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
* Burkinabe nationality
* Permanent residence in the study area with no intention of leaving during the surveillance period
* Informed consent
Exclusion Criteria
* Vomiting (3 or more within 24 hours before the visit)
* Any apparent significant disease, including severe malnutrition
* A history of a previous, significant adverse reaction to either 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)
* Simultaneous participation in another investigational study
* Treatment with other investigational drugs
6 Months
59 Months
ALL
No
Sponsors
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Heidelberg University
OTHER
Responsible Party
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Institut of Public Health, University of Heidelberg
Principal Investigators
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Olaf Müller, Prof Dr
Role: PRINCIPAL_INVESTIGATOR
Institut of Public health, University of heidelberg
Locations
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Nouna Health District
Nouna, Mouhoun, Burkina Faso
Countries
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References
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Coulibaly B, Pritsch M, Bountogo M, Meissner PE, Nebie E, Klose C, Kieser M, Berens-Riha N, Wieser A, Sirima SB, Breitkreutz J, Schirmer RH, Sie A, Mockenhaupt FP, Drakeley C, Bousema T, Muller O. Efficacy and safety of triple combination therapy with artesunate-amodiaquine-methylene blue for falciparum malaria in children: a randomized controlled trial in Burkina Faso. J Infect Dis. 2015 Mar 1;211(5):689-97. doi: 10.1093/infdis/jiu540. Epub 2014 Sep 28.
Other Identifiers
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SFB544A8
Identifier Type: -
Identifier Source: org_study_id