Status:
COMPLETED
Efficacy and Safety of Artesunate-amodiaquine-methylene for Malaria Treatment in Children
Lead Sponsor:
Heidelberg University
Conditions:
Uncomplicated Falciparum Malaria
Eligibility:
All Genders
6-59 years
Phase:
PHASE2
Brief Summary
Title: Efficacy and safety of artesunate-amodiaquine combined with methylene blue for falciparum malaria treatment in African children: randomised controlled trial. Design: Mono-centre, two arms, ope...
Eligibility Criteria
Inclusion
- 6-59 months old children (male and female)
- 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
- Severe malaria (WHO 2000)
- 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
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT01407887
Start Date
August 1 2011
End Date
December 1 2011
Last Update
December 5 2012
Active Locations (1)
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1
Nouna Health District
Nouna, Mouhoun, Burkina Faso, P.O. Box 34