Status:
COMPLETED
Effectiveness of the Association Artesunate and Mefloquine in the Treatment of Malaria by Plasmodium Falciparum
Lead Sponsor:
Oswaldo Cruz Foundation
Collaborating Sponsors:
Pan American Health Organization
Ministry of Health, Brazil
Conditions:
Falciparum Malaria
Eligibility:
All Genders
6-70 years
Phase:
PHASE2
PHASE3
Brief 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 municipal...
Detailed Description
* Objectives: To evaluate the efficacy of the fixed combination of artesunate + mefloquine in the treatment of uncomplicated malaria caused by Plasmodium falciparum, in the county (municipality) of Cr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
163 Patients enrolled
Trial Details
Trial ID
NCT01144702
Start Date
November 1 2010
End Date
July 1 2014
Last Update
May 19 2015
Active Locations (2)
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1
Oswaldo Cruz Foundation
Rio de Janeiro, Rio de Janeiro, Brazil, 21045-900
2
Institute of Biomedical Sciences, University of Sao Paulo
São Paulo, São Paulo, Brazil, 05508-900