Status:
COMPLETED
Assessment of the Therapeutic Efficacy and Tolerability of the Artesunate/Amodiaquina Combination and Artemether/Lumefantrine Combination, Treatment of Uncomplicated P. Falciparum Malaria in the Department of Chocó (Colombia)
Lead Sponsor:
Universidad Nacional de Colombia
Collaborating Sponsors:
Sanofi Pasteur, a Sanofi Company
Conditions:
P. Falciparum Malaria
Eligibility:
All Genders
18-100 years
Phase:
PHASE4
Brief Summary
Background: Malaria by P falciparum is a public health problem in more than 100 municipalities of Colombia. The country is using the artemether+lumefantrine (AM+L) fixed combination for uncomplicated ...
Detailed Description
Design: An open-labeled, randomized and controlled clinical trial with follow-up in days 1, 2, 3, 4, 7, 14, 21 and 28 was carried out in adult patients with uncomplicated P. falciparum malaria. This t...
Eligibility Criteria
Inclusion
- Age \> 18 years
- fever (axillary temperature \>37.5º C) or history of fever during the prior 48 hours in absence of another obvious cause (such as pneumonia, otitis media)
- a non-mixed P. falciparum infection with 250 and 100,000 asexual parasites/µl to be determined by a thick film or thick film and blood smear microscopic test
Exclusion
- Not being able to drink
- vomiting (more than twice within the prior 24 hours)
- recent history of seizures (1 or more in the previous 24 hours)
- alteration of the consciousness level
- not being able to seat or stand up, signs of serious malaria (World Health Organization criteria)
- other chronic or severe diseases (i.e., cardiac, renal and hepatic diseases, HIV/AIDS, severe malnutrition)
- history of hypersensibility to any of the study drugs or drugs used as alternative treatment (i.e. mefloquine, artesunate, quinine or tetracycline/clindamycin)
- suspicion of pregnancy or pregnancy (based on a urine pregnancy test).
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT04877626
Start Date
September 1 2008
End Date
December 1 2009
Last Update
May 7 2021
Active Locations (1)
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1
San Rafael Hospital in Quibdó Chocó
Quibdó, Departamento del Chocó, Colombia, 57