- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00545935
Safety and Efficacy of Methylene Blue Combined With Amodiaquine or Artesunate for Malaria Treatment in Children of Burkina Faso
February 2, 2009 updated by: Heidelberg University
Safety and Efficacy of Methylene Blue Combined With Amodiaquine or Artesunate for Malaria Treatment in Children of Burkina Faso: RCT in the Frame of the A8 Project of SFB 544
The purpose of the study is to investigate the safety and efficacy profile of a new paediatric MB formulation combined with AQ or AS and compared to AS-AQ in young African children with uncomplicated falciparum malaria.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment
186
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Nouna, Burkina Faso
- Centre de recherche en Santé de nouna
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 months to 4 years (Child)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 0.5-5 year (6-59 months) old children
- uncomplicated malaria caused by P. falciparum
- asexual parasites ≥ 2000/µ and ≤ 200000/µ
- axillary temperature ≥ 37.5 Celsius or a history of fever during last 24 hours
- Burkinabe nationality
- informed consent
Exclusion Criteria:
- complicated or severe malaria
- any apparent significant disease
- anaemia (haematocrit < 21%)
- treated in the same trial before
- modern antimalarial treatment prior to inclusion (last three days), except children having been treated with chloroquine
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1-Methylenblue-Amodiaquine
|
For 3 days twice daily 10 mg/kg MB accompanied by once daily 10 mg/kg AQ
|
Active Comparator: 2-Methylenblue-Artesunate
|
3 days once daily 4 mg/kg AS accompanied by twice daily 10 mg/kg MB given over 7 days
|
Active Comparator: 3-Artesunate-Amodiaquine
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For 3 days once daily 10 mg/kg AQ accompanied by 4mg/kg AS.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of observed and self-reported non-serious adverse events over the 28 days observation period
Time Frame: 28 days
|
28 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of serious adverse events (SAE) and the adequate clinical and parasitological response rate (ACPR)
Time Frame: 28 days
|
28 days
|
Early treatment failure (ETF) rate
Time Frame: 28 days
|
28 days
|
Late clinical failure (LCF) rate at D14 and D28
Time Frame: 28 days
|
28 days
|
Late parasitological failure (LPF) rate at D14 and D28
Time Frame: 28 days
|
28 days
|
Fever clearance time
Time Frame: 28 days
|
28 days
|
Parasite clearance time
Time Frame: 28 days
|
28 days
|
Change in haematocrit after 2,14 and 28 days compared to baseline
Time Frame: 28 days
|
28 days
|
MB whole blood concentrations on D3,5 or 7 compared to concentrations after the first dose
Time Frame: 28 days
|
28 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Olaf Mueller, Prof., Heidelberg University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2007
Study Completion
October 1, 2007
Study Registration Dates
First Submitted
October 16, 2007
First Submitted That Met QC Criteria
October 16, 2007
First Posted (Estimate)
October 17, 2007
Study Record Updates
Last Update Posted (Estimate)
February 3, 2009
Last Update Submitted That Met QC Criteria
February 2, 2009
Last Verified
February 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MB-2007b
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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