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Falciparum MalariaPhase 2/3NCT01144702

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

A Phase 2/3 study testing artesunate & mefloquine combination in people with Falciparum Malaria, run by Oswaldo Cruz Foundation at 2 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 months to 70 years
Conditions the study is for
Falciparum Malaria
What is being tested?
artesunate & mefloquine combination
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
163 participants
Where
2 sitesBrazil
Study dates
Nov 2010to Jul 2014
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 months to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

Brazil2 sites

  • Oswaldo Cruz Foundation

    Rio de Janeiro, Rio de Janeiro, 21045-900

  • Institute of Biomedical Sciences, University of Sao Paulo

    São Paulo, São Paulo, 05508-900

Other trials in Brazil

About this study

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.

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.

Read the 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 Cruzeiro do Sul, Juruá Valley, State of Acre (AC), Brazil, where it was being used as specific first-line drug.
  • Selection Criteria : Persons aged between 6 months and 70 years with history of fever in the last 48 hours that had a confirmed diagnosis of mono-infection by Plasmodium falciparum (F or F+Fg) with parasitemia of 250 to 100000 parasites/μl and absence of signs of severe malaria, malnutrition or another severe disease. Pregnant women were not included.
  • Intervention: Three days of supervised treatment with the fixed combination of artesunate+mefloquine (ASMQ-Farmanguinhos/Fiocruz) in accordance with the scheme recommended by the Ministry of Health, respecting four age and weight groups based on the target dose of each drug (artesunate -4 mg/kg/dose and 12 mg/kg of total dose, mefloquine- 8 mg/kg/dose and 24 mg/kg of total dose). Patients in the range of 5 to <18 kg (6 months to 5 years old) received the combination in pediatric presentation (ASMQ 25 + 50mg) and subjects with 18 kg or more (6 years or more years old) received the presentation ASMQ 100 + 200mg.
  • Main Outcomes: The proportion of subjects who had experienced treatment failure during the following 42 days is used to estimate the effectiveness of the antimalarial combination in this study. Adverse events and speed of resolution of the clinical and infectious status are described. The phenotype of multidrug resistance (MDR) was investigated in the population of P. falciparum present in the subjects of the study.
  • Methods: A therapeutic trial of a single "arm" for prospective evaluation of clinical and parasitological response of at least 100 individuals with uncomplicated malaria by P. falciparum treated with artesunate+mefloquine combination for three days and monitored for 42 days. The follow-up was done with assessments in the first four days and then once a week until the day 42. During the visits, subjects were submitted to an interview, clinical examination, temperature measurement and collection of venous (D0, D3 and D42) or capillar (all visits) blood samples for hemogram (D0, D3 and D42) and parasitological exam (all visits). The parasitological evaluation was done by microscopy (immediately with review later) and real time PCR (qPCR) in order to confirm the infecting specie of Plasmodium, to detect gametocytes and to measure the parasitemia (parasites/μl). ). The blood samples of D0 (before the treatment) was used to evaluate the phenotype of multidrug resistance (MDR) in the population of P. falciparum.
  • 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 was being used as the first line treatment of uncomplicated malaria caused by Plasmodium falciparum in the Valley Juruá since 2006 and still is recognized by the Ministry of Health as an alternative to the combination of artemether + lumefantrine in Brazil. If necessary, the study subjects could be admitted to the General Hospital Juruá seat of outpatient malaria. Medical and laboratory support was guaranteed free of charge to all study subjects and for all health problems that have been present during the follow-up.
  • What the study adds to knowledge in public health? : This study offers a crucial knowledge to guide the development of policies to antimalarial drugs in endemic areas.
Being tested
artesunate & mefloquine combination
Keywords
malaria, Plasmodium falciparum, artesunate and mefloquine combination (ASMQ), treatment, Juruá Valley, Brazil, multidrug resistance 1 gene of Plasmodium falciparum -Pfmdr1
Medical subject headings
Malaria, Falciparum, Malaria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • artesunate & mefloquine combinationDrug

    Also called ASMQ

    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.

Study groups in NCT01144702
Study groupRoleWhat they receive
artesunate & mefloquine combinationExperimentalASMQ 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.
Receives: Drug: artesunate & mefloquine combination

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 42 days

Secondary outcomes (1)

  1. Description of adverse events

    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.

    Measured: 42 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2010 (estimated)
  2. Study startNov 2010
  3. Primary completionApr 2013
  4. Study completionJul 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
163 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01144702
Sponsor's protocol ID
001/ASMQ/JURUA/2009
Status last verified
May 2015
First submitted
14 Jun 2010
Last updated
19 May 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 27068396

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing artesunate & mefloquine combination in people with Falciparum Malaria, run by Oswaldo Cruz Foundation at 2 sites in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

treatment failure (time frame: 42 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01144702, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2015.

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