Status:
COMPLETED
Efficacy and Safety of Dihydroartemisinin/Piperaquine (Artekin®) for the Treatment of Uncomplicated Malaria in Peru
Lead Sponsor:
Institute of Tropical Medicine, Belgium
Conditions:
Malaria
Eligibility:
All Genders
5-60 years
Phase:
PHASE3
Brief Summary
In Peru, Mefloquine plus Artesunate (MAS3), is the current first line treatment for P. falciparum malaria in the Amazonian Region, and has proved its efficacy against multi-resistant P. falciparum par...
Detailed Description
In Peru, Mefloquine plus Artesunate (MAS3), is the current first line treatment for P. falciparum malaria in the Amazonian Region, and has proved its efficacy against multi-resistant P. falciparum par...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Age: 5 - 60 years old
- Fever (axillary temperature equal or higher than 37,5 °C) or history of fever in the previous 24 hours
- Monoinfection with P. falciparum, with parasitic density between 1,000 and 200,000 par/µl
- Informed consent provided by patient or parent or legal tutor
- • Exclusion criteria:
- Mixed malaria infection
- Pregnancy or breastfeeding to child ≤ 6 months of age
- One or more danger signs or any sign of severe or complicated malaria
- A concomitant severe disease
- History of treatment with mefloquine in the last 60 days or chloroquine, primaquine or quinine within the 14 days before the present episode
- History of neuropsychiatric disease
- History of hypersensitivity reactions to artemisinins or mefloquine
- History of splenectomy
Exclusion
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2005
Estimated Enrollment :
522 Patients enrolled
Trial Details
Trial ID
NCT00373607
Start Date
July 1 2003
End Date
July 1 2005
Last Update
September 14 2010
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.