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

Condition(s) targeted: Falciparum Malaria

Intervention: fixed combination of artesunate + mefloquine (ASMQ) (Drug)

Phase: Phase 2/Phase 3

Status: Recruiting

Sponsored by: Oswaldo Cruz Foundation

Official(s) and/or principal investigator(s):
Simone L Andrade, PhD, Study Director, Affiliation: Oswaldo Cruz Institute, Oswaldo Cruz Foundation

Overall contact:
Simone L Andrade, PhD, Phone: +55-21-25621302, Email: sladeia@ioc.fiocruz.br

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.

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.

Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: treatment failure

Secondary outcome: Description of adverse events

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.

Minimum age: 6 Months. Maximum age: 70 Years. Gender(s): Both.

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.

Simone L Andrade, PhD, Phone: +55-21-25621302, Email: sladeia@ioc.fiocruz.br

Oswaldo Cruz Foundation, Rio de Janeiro 21045-900, Brazil; Recruiting
Simone L Andrade, PhD, Phone: +55-21-25621302, Email: sladeia@ioc.fiocruz.br
Marcelo U Ferreira, PhD, Phone: +55-11-30917746, Email: muferrei@usp.br
Simone L Andrade, PhD, Principal Investigator
Marcelo U Ferreira, PhD, Sub-Investigator
Rita de Cássia S Lima, physician, Sub-Investigator

Institute of Biomedical Sciences, University of Sao Paulo, São Paulo 05508-900, Brazil; Recruiting
Marcelo U Ferreira, PhD, Phone: +55-11-30917746, Email: muferrei@usp.br
Simone L Andrade, PhD, Phone: +55-21-25621302, Email: sladeia@ioc.fiocruz.br
Simone L Andrade, PhD, Principal Investigator
Marcelo U Ferreira, PhD, Sub-Investigator
Rita de Cássia S Lima, Physician, Sub-Investigator

Starting date: December 2010
Last updated: July 21, 2011