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Harmonized AS/MQ Efficacy Study - Thailand

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ClinicalTrials.gov Identifier: NCT02052323
Recruitment Status : Completed
First Posted : February 3, 2014
Last Update Posted : January 25, 2016
Sponsor:
Collaborators:
Walter Reed Army Institute of Research (WRAIR)
Global Emerging Infections Surveillance and Response System
Information provided by (Responsible Party):
Armed Forces Research Institute of Medical Sciences, Thailand

Brief Summary:
The purposes of this study is to determine parasitological clearance rates by microscopy for the 72-hour period after first artesunate dose in subjects with uncomplicated P. falciparum malaria.

Condition or disease Intervention/treatment Phase
Malaria Drug: Artesunate/mefloquine (AS/MQ) Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study to Determine the Efficacy of Artesunate-mefloquine Combination Therapy for the Treatment of Uncomplicated P. Falciparum Malaria in Thailand
Study Start Date : October 2013
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arm Intervention/treatment
Experimental: artesunate/mefloquine (AS/MQ)
The antimalarial drug regimen being evaluated is: artesunate (AS) 4mg/kg by mouth once daily at 0, 24 and 48 hours; plus mefloquine (MQ) 15mg/kg by mouth once at 72 hours, and 10mg/kg once by mouth at 84-96 hours; plus primaquine (PQ) 0.5mg/kg single dose by mouth at 84-96 hours
Drug: Artesunate/mefloquine (AS/MQ)
  • artesunate (AS) 4mg/kg by mouth once daily at 0, 24 and 48 hours
  • mefloquine (MQ) 15mg/kg by mouth once at 72 hours, and 10mg/kg once by mouth at 84-96 hours
  • primaquine (PQ) 0.5mg/kg single dose by mouth at 84-96 hours
Other Name: Mequin




Primary Outcome Measures :
  1. Parasite clearance rate [ Time Frame: one year ]
    Parasite clearance rate as defined by the slope of the linear portion of the logarithm parasite clearance curve using microscopy to determine parasitemia


Secondary Outcome Measures :
  1. Number of patients with prolonged parasite clearance times, adequate drug levels and positive molecular markers of parasite resistance. [ Time Frame: one year ]
    • Parasite clearance rate during the first 72 hours after artesunate administration as defined by the slope of the linear portion of the logarithm parasite clearance curve using qPCR
    • Parasite reduction ratios at 24 and 48 hours assessed by microscopy and qPCR
    • Time for parasite count to fall to 50%, 90%, 99% and 100% of initial parasite density
    • Fever clearance time
    • 42-day PCR-adjusted treatment efficacy
    • Gametocyte carriage rates
    • Plasma levels of AS, DHA and MQ at selected time points
    • In vitro IC50, IC90, IC99 P. falciparum responses to a panel of antimalarial drugs, including dihydroartemisinin (DHA) and mefloquine
    • Parasite molecular markers of drug resistance as determined by GWAS, SNP analysis and other genotyping methodologies
    • A detailed characterization of drug-resistant malaria using integrated endpoints above, including clinical, in vitro and molecular


Other Outcome Measures:
  1. Numbers of patients with features suggestive of antimalarial drug resistance in Thailand with partner sites in Kenya and Peru. [ Time Frame: One year ]
    • Comparison of clinical and parasitological outcomes and in vitro and molecular features of parasites between harmonized sites in Kenya and Peru
    • Identification of host factors that correlate with slow parasite clearance and other clinical outcomes
    • Creation of a well-characterised catalog of malaria parasites for future research



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Ages Eligible for Study:   5 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Thai or non-Thai, otherwise healthy, male or female, aged from 5 years to 65 years inclusive
  • Acute uncomplicated P. falciparum malaria monoinfection, confirmed by positive blood smear
  • Asexual P. falciparum parasitaemia of 1,000 to 200,000 parasites/µL, confirmed on a thin or thick blood film
  • Fever defined as ≥ 38.0°C tympanic temperature (or equivalent) or a history of fever within the last 24 hours
  • Willingness to participate in the study as evidenced by written informed consent from the subject or parent/guardian (for children), and by assent (for children)

Exclusion criteria:

  • Severe malaria as defined by WHO criteria (reference WHO 2012)
  • Inability to eat or drink, inability to tolerate oral antimalarial medication, recent history of seizures (one or more in the previous 24 hours), altered level of consciousness, inability to sit or stand
  • Mixed species asexual stage malaria infection as determined by microscopy
  • Recent antimalarial treatment, defined as a clear history of any antimalarial medication taken within the previous 7 days; or a clear history of mefloquine within previous 4 weeks
  • History of splenectomy
  • Pregnancy or nursing mother
  • Known hypersensitivity to artesunate, mefloquine or primaquine
  • PI determines that it is in the best interests of the subject not to participate in the trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02052323


Locations
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Thailand
Kwai River Christian Hospital in Sangklaburi
Amphoe Sangkhlaburi, Kanchanaburi, Thailand, 71240
Sponsors and Collaborators
Armed Forces Research Institute of Medical Sciences, Thailand
Walter Reed Army Institute of Research (WRAIR)
Global Emerging Infections Surveillance and Response System
Investigators
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Principal Investigator: Krisada Jongsakul, MD Armed Forces Research Institute of Medical Sciences, Thailand

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Responsible Party: Armed Forces Research Institute of Medical Sciences, Thailand
ClinicalTrials.gov Identifier: NCT02052323     History of Changes
Other Study ID Numbers: WRAIR2017
First Posted: February 3, 2014    Key Record Dates
Last Update Posted: January 25, 2016
Last Verified: January 2016

Keywords provided by Armed Forces Research Institute of Medical Sciences, Thailand:
P.f Malaria, Artemisinin resistance, ACT treatment failure

Additional relevant MeSH terms:
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Malaria
Protozoan Infections
Parasitic Diseases
Artesunate
Mefloquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics