Effectiveness of the Association Artesunate and Mefloquine in the Treatment of Malaria by Plasmodium Falciparum
1 other identifier
interventional
163
1 country
2
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 municipality of Cruzeiro do Sul, Juruá Valley, Brazil, where it was being used as specific first-line drug.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2010
Typical duration for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 14, 2010
CompletedFirst Posted
Study publicly available on registry
June 15, 2010
CompletedStudy Start
First participant enrolled
November 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedMay 19, 2015
May 1, 2015
2.4 years
June 14, 2010
May 15, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
treatment failure
The efficacy of the treatment will be based on clinical and parasitological evaluation of the participants, conducted in all follow-up visits during the 48 days. All individuals will be classified in: a) Early treatment failure b) Late Clinical Failure, Late Parasitological Failure and adequate clinical and parasitological response. As the parasitological cure is the endpoint of treatment of malaria, all individuals classified as treatment failure should be treated with the alternative scheme (quinine + doxycycline).
42 days
Secondary Outcomes (1)
Description of adverse events
42 days
Study Arms (1)
artesunate & mefloquine combination
EXPERIMENTALASMQ will be administered to individuals with uncomplicated malaria by P. falciparum according to the dose regimen for age and weight, standardized (Farmanguinhos, Ministry of Health). For patients in the range of 5 to \<18kg (6 months to 5 years old), will be offered treatment in the pediatric presentation of Artesunate+Mefloquine 25 +50 mg (5 to \<9 kg = 1 tablet once daily for 3 days, 9 to \<18 kg = 2 tablets once daily for 3 days). To study subject aged 18 or more kilos (six years or more years old) will be given the combination of Artesunate + Mefloquine presentation ASMQ 100 +200 mg (18 to 29 kg = 1 tablet once daily for 3 days, 30 kg or more = 2 tablets once daily for 3 days). Clinically and biochemically monitoring will be done for 42 days.
Interventions
A therapeutic trial of a single arm for prospective evaluation of responses of individuals with uncomplicated malaria by P. falciparum treated with combination artesunate + mefloquine for three days and monitored clinically and biochemically for 42 days.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oswaldo Cruz Foundationlead
- Pan American Health Organizationcollaborator
- Ministry of Health, Brazilcollaborator
- University of Sao Paulocollaborator
Study Sites (2)
Oswaldo Cruz Foundation
Rio de Janeiro, Rio de Janeiro, 21045-900, Brazil
Institute of Biomedical Sciences, University of Sao Paulo
São Paulo, São Paulo, 05508-900, Brazil
Related Publications (1)
Ladeia-Andrade S, de Melo GN, de Souza-Lima Rde C, Salla LC, Bastos MS, Rodrigues PT, Luz Fd, Ferreira MU. No Clinical or Molecular Evidence of Plasmodium falciparum Resistance to Artesunate-Mefloquine in Northwestern Brazil. Am J Trop Med Hyg. 2016 Jul 6;95(1):148-54. doi: 10.4269/ajtmh.16-0017. Epub 2016 Apr 11.
PMID: 27068396DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Simone L Andrade, PhD
Oswaldo Cruz Institute, Oswaldo Cruz Foundation
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 14, 2010
First Posted
June 15, 2010
Study Start
November 1, 2010
Primary Completion
April 1, 2013
Study Completion
July 1, 2014
Last Updated
May 19, 2015
Record last verified: 2015-05