Status:
COMPLETED
Safety and Efficacy of Methylene Blue Combined With Artesunate or Amodiaquine for Malaria Treatment in Children of Burkina Faso: a Pilot Study
Lead Sponsor:
Heidelberg University
Conditions:
Malaria
Eligibility:
All Genders
6-10 years
Phase:
PHASE2
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 a...
Detailed Description
Objectives: The primary objective of this trial is to study the safety of the combination methylene blue (MB)-artesunate (AS) and MB-amodiaquine (AQ) given over three days in 6-10 year old children wi...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 6-10 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
- Exclusion Criteria:
- Complicated or severe malaria
- Any apparent significant disease
- Anaemia (haematocrit \< 21%)
- Treated in the same trial before
- Antimalarial treatment prior to inclusion (last three days), except children having been treated with chloroquine
Exclusion
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
End Date :
November 1 2006
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00354380
Start Date
September 1 2006
End Date
November 1 2006
Last Update
October 24 2006
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Nouna District Hospital
Nouna, Burkina Faso