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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Oswaldo Cruz Foundation
Sponsor:
Collaborators:
Pan American Health Organization
Ministry of Health, Brazil
University of Sao Paulo
Information provided by (Responsible Party):
Oswaldo Cruz Foundation
ClinicalTrials.gov Identifier:
NCT01144702
First received: June 14, 2010
Last updated: March 9, 2013
Last verified: March 2013
  Purpose

The purpose of this study is to evaluate whether the fixed combination of artesunate+mefloquine has been effective in the treatment of uncomplicated malaria caused by Plasmodium falciparum at the Juruá Valley, Brazil, where it has been used.


Condition Intervention Phase
Falciparum Malaria
Drug: artesunate & mefloquine combination
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effectiveness of the Association Artesunate and Mefloquine in the Treatment of Uncomplicated Malaria by Plasmodium Falciparum, Juruá Valley, State of Acre, Brazil, 2009.

Resource links provided by NLM:


Further study details as provided by Oswaldo Cruz Foundation:

Primary Outcome Measures:
  • treatment failure [ Time Frame: 42 days ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Description of adverse events [ Time Frame: 42 days ] [ Designated as safety issue: Yes ]
    Any sign or symptom that is not present in the clinical evaluation of D0 and focusing on subsequent evaluations, will be defined as adverse effects of the treatment. For this, a list of signs and symptoms should be questioned participants at all follow-up visits and adverse effects identified will be properly recorded. Depending on the intensity, these adverse effects should be treated according to medical advice. The subject of the study with more severe adverse effects will be referenced to a secondary or tertiary health care for the Juruá Hospital.


Estimated Enrollment: 100
Study Start Date: December 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: artesunate & mefloquine combination
ASMQ 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.
Drug: artesunate & mefloquine combination
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.
Other Name: ASMQ

Detailed Description:
  • Objectives: To evaluate the efficacy of the fixed combination of artesunate + mefloquine in the treatment of uncomplicated malaria caused by Plasmodium falciparum, the municipalities of the Cruzeiro do Sul, Mâncio Lima and Rodrigues Alves, who make up the Juruá Valley, State of Acre (AC), Brazil, in 2009.
  • Selection Criteria : Persons aged between 6 months and 70 years, the demand outpatient malaria from Juruá Regional Hospital, Cruzeiro do Sul with a confirmed diagnosis of mono-infection by Plasmodium falciparum (F or F + Fg) and parasitemia of + a + + +.
  • Intervention: Treatment with the fixed combination of artesunate + mefloquine in accordance with the scheme recommend the Ministry of Health, respecting the weight groups and age.
  • Main Outcomes: The proportion of study subjects that are experiencing treatment failure during the following 28 days will be used to estimate the effectiveness of antimalarials drugs in this study. Description of adverse events.
  • Methods: A therapeutic trial of a single "arm" for prospective evaluation of clinical and parasitological responses of individuals with uncomplicated malaria by P. falciparum treated with the combination artesunate + mefloquine for three days and monitored clinically and biochemically for 42 days.
  • Potential risks to participants: The action proposed does not add risks beyond those inherent to the treatment and course of illness, since the fixed combination artesunate + mefloquine is the first line treatment of uncomplicated malaria caused by Plasmodium falciparum in the Valley Juruá since 2006 and is recognized by the Ministry of Health as an alternative to the combination of artemether + lumefantrine first line in Brazil. If necessary, the study subjects will be admitted to the General Hospital Juruá seat of outpatient malaria. Medical and laboratory will be guaranteed free of charge to all study subjects and for all health problems that may present during the follow-up.
  • What the study adds to knowledge in public health? : This is study offers a crucial knowledge to guide the development of policies to antimalarial drugs in endemic areas.
  Eligibility

Ages Eligible for Study:   6 Months to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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/uL and 100.000/uL;
  • 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 IC.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01144702

Contacts
Contact: Simone L Andrade, PhD +55-21-25621302 sladeia@ioc.fiocruz.br
Contact: Marcelo U Ferreira, PhD +55-11-30917746 muferrei@usp.br

Locations
Brazil
Oswaldo Cruz Foundation Recruiting
Rio de Janeiro, Brazil, 21045-900
Contact: Simone L Andrade, PhD    +55-21-25621302    sladeia@ioc.fiocruz.br   
Contact: Marcelo U Ferreira, PhD    +55-11-30917746    muferrei@usp.br   
Principal Investigator: Simone L Andrade, PhD         
Sub-Investigator: Marcelo U Ferreira, PhD         
Sub-Investigator: Rita de Cássia S Lima, physician         
Institute of Biomedical Sciences, University of Sao Paulo Recruiting
São Paulo, Brazil, 05508-900
Contact: Marcelo U Ferreira, PhD    +55-11-30917746    muferrei@usp.br   
Contact: Simone L Andrade, PhD    +55-21-25621302    sladeia@ioc.fiocruz.br   
Principal Investigator: Simone L Andrade, PhD         
Sub-Investigator: Marcelo U Ferreira, PhD         
Sub-Investigator: Rita de Cássia S Lima, Physician         
Sub-Investigator: Gladson NP de Melo, nurse         
Sponsors and Collaborators
Oswaldo Cruz Foundation
Pan American Health Organization
Ministry of Health, Brazil
University of Sao Paulo
Investigators
Study Director: Simone L Andrade, PhD Oswaldo Cruz Institute, Oswaldo Cruz Foundation
  More Information

No publications provided

Responsible Party: Oswaldo Cruz Foundation
ClinicalTrials.gov Identifier: NCT01144702     History of Changes
Other Study ID Numbers: 001/ASMQ/JURUA/2009
Study First Received: June 14, 2010
Last Updated: March 9, 2013
Health Authority: Brazil: Ministry of Health

Keywords provided by Oswaldo Cruz Foundation:
malaria
Plasmodium falciparum
association artesunate and mefloquine
effectiveness
Juruá Valley

Additional relevant MeSH terms:
Malaria
Malaria, Falciparum
Parasitic Diseases
Protozoan Infections
Artesunate
Mefloquine
Amebicides
Anti-Infective Agents
Antimalarials
Antiparasitic Agents
Antiprotozoal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014