Safety and Efficacy of Methylene Blue Combined With Artesunate or Amodiaquine for Malaria Treatment in Children of Burkina Faso: a Pilot Study
1 other identifier
interventional
N/A
1 country
1
Brief Summary
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 secondary objective is to investigate the efficacy of MB-AS and MB-AQ.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Sep 2006
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 19, 2006
CompletedFirst Posted
Study publicly available on registry
July 20, 2006
CompletedStudy Start
First participant enrolled
September 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2006
CompletedOctober 24, 2006
September 1, 2006
July 19, 2006
October 23, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of observed and self-reported non-serious adverse events over the 28 days observation period (definition chapter 11)
Secondary Outcomes (8)
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
- +3 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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
- Burkinabe nationality
- Informed consent
You may not qualify if:
- Complicated or severe malaria
- Any apparent significant disease
- Anaemia (haematocrit \< 21%)
- Treated in the same trial before
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nouna District Hospital
Nouna, Burkina Faso
Related Publications (2)
Coulibaly B, Zoungrana A, Mockenhaupt FP, Schirmer RH, Klose C, Mansmann U, Meissner PE, Muller O. Strong gametocytocidal effect of methylene blue-based combination therapy against falciparum malaria: a randomised controlled trial. PLoS One. 2009;4(5):e5318. doi: 10.1371/journal.pone.0005318. Epub 2009 May 5.
PMID: 19415120DERIVEDZoungrana A, Coulibaly B, Sie A, Walter-Sack I, Mockenhaupt FP, Kouyate B, Schirmer RH, Klose C, Mansmann U, Meissner P, Muller O. Safety and efficacy of methylene blue combined with artesunate or amodiaquine for uncomplicated falciparum malaria: a randomized controlled trial from Burkina Faso. PLoS One. 2008 Feb 20;3(2):e1630. doi: 10.1371/journal.pone.0001630.
PMID: 18286187DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Olaf Mueller, MD, MPH
Heidelberg University
- PRINCIPAL INVESTIGATOR
Peter Meissner, MD, MSc Trop Paed
Heidelberg University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 19, 2006
First Posted
July 20, 2006
Study Start
September 1, 2006
Study Completion
November 1, 2006
Last Updated
October 24, 2006
Record last verified: 2006-09