Effectiveness of the Association Artesunate and Mefloquine in the Treatment of Malaria by Plasmodium Falciparum

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study was to evaluate the effectiveness of the fixed combination of artesunate+mefloquine in the treatment of uncomplicated malaria caused by Plasmodium falciparum in the municipality of Cruzeiro do Sul, Juruá Valley, Brazil, where it was being used as specific first-line drug.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oswaldo Cruz Foundation
• Collaborators: Ministry of Health, Brazil; Pan American Health Organization; University of Sao Paulo
• Treatments: Artemisinins; Artesunate; Mefloquine

Criteria

Inclusion Criteria:

• Be aged between 6 months and 70 years old;

• Be with mono-infection confirmed laboratorial by P.falciparum;

• Having parasite count between 250/µl and 100000/µl;

• If female, not pregnant, confirmed by specific test;

• Being feverish or report having had fever (axillary temperature >37.5°C or 99,5°F) in last 48 hours;

• Be able to receive oral medication;

• Demonstrate interest and facility to meet the schedule of visits and monitoring for 42 days;

• Agree to participate in the study by signature (or parents) of Consent Term;

• Do not show evidence of severe malnutrition: underweight 60% of the weight-standard, below-average height for age indicating malnutrition in the past and weight-height below the average indicating dietary current deficiencies (WHO, 2006);

• Do not show danger signals to severe malaria. Note: We will be careful to include individuals who have used quinine or quinidine recently (three days before), because the risk of toxicity due to interaction with mefloquine.

Exclusion Criteria:

• Present after inclusion, danger signs/symptoms for severe malaria as recommended by the WHO;

• Present after inclusion, laboratory evidence of mixed infection with another species of Plasmodium;

• Having a diagnosis of other acute infectious disease that courses with fever, such as acute respiratory infection, common viruses of childhood diarrhea, etc;

• Having a diagnosis of chronic co morbidities or severe disease such as cirrhosis, chronic renal failure or heart failure;

• Have a history of hypersensitivity to the components of the combination ASMQ.