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)

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

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 P falciparum malaria but it is ideal to have different types of formulations with similar efficacy that may be used in diverse circumstances. One alternative of treatment is using preparations containing artesunate and amodiaquine (AS+AQ) in fixed combination, which can be given in a simpler dosing regimen. In order to assess the efficacy of that combination in an area with suspected risk of resistance to amodiaquine an open controlled clinical trial was carried out in Colombia. Methods: The study was done in Choco, a high endemic area for malaria by P falciparum, from August 2008 and September 2009. Patients diagnosed with uncomplicated malaria (n=210) malaria were randomized in two arms, one receiving AS+AQ and the other AM+L. The main clinical results was parasitological cure, i.e. a negative blood smears, that was assessed, for both groups, at days 1, 2, 3, 7, 14, 21 and 28 after the onset of treatment. Results: There were no losses at follow up. The mean age of the enrolled study subjects was of 37.5 years without differences between study arms. Both therapies were very well tolerated in general. The efficacy for AS+AQ was 100%, and 99% for AM+L (p>0.1). In average, patients in the AS+AQ arm became negative for P falciparum parasites and gametocytes earlier than those at the AM+L arm. Blood smears became negative after one day of treatment with AS+AQ and after two days of treatment with AM+L. Gametocytes disappeared after 2 days of treatment in the AS+AQ arm compared to 4 days in the AM+L arm. Conclusions: In this study, the efficacy of the AS+AQ combination was similar to that of the AM+L. This finding do not support the hypothesis that there is a level of resistance to amodiaquine that prevents its use combined with artemisinin derived.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universidad Nacional de Colombia
• Collaborator: Sanofi Pasteur, a Sanofi Company
• Treatments: Artesunate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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).