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ISRCTN
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ISRCTN12741594
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ClinicalTrials.gov identifier
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Public title
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Is there any evidence of antimalarial resistance to artemisinin derivatives in southern Laos?
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Scientific title
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Clinical investigation of in-vivo susceptibility of Plasmodium falciparum to artesunate in Xepon Inter-District Hospital, Savannakhet Province, Laos
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Acronym
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Anredaud
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Serial number at source
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N/A
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Study hypothesis
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The parasite clearance times (PCT) and the efficacy after 2 mg/kg and 4 mg/kg oral artesunate, followed by 3-days artemether-lumefantrine, are not prolonged.
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Lay summary
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Ethics approval
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1. Oxford Tropical Research Ethics Committee (UK) approved on the 8th June 2009 (ref: OXTREC 29-09)
2. Lao PDR National Ethics Committee for Health Research (NECHR) approved on the 18th May 2009 (Ref: 246/NECHR)
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Study design
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Open randomised controlled trial
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Countries of recruitment
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Laos
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Disease/condition/study domain
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Plasmodium falciparum malaria, antimalarial drugs
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Participants - inclusion criteria
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1. Male and female, aged greater than 10 years
2. Female patients between ages of 10 and 12 years old, provided they have not reached menarche, and those who have passed through the menopause
3. Mono-infection with P. falciparum as detected by microscopy
4. Parasitaemia of 10,000 - 175,000/µl asexual forms
5. Presence of axillary or tympanic temperature greater than or equal to 37.5°C or oral or rectal temperature of greater than or equal to 38°C or history of fever during the past 24 hours
6. Ability to swallow oral medication
7. Ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule
8. Informed consent from the patient or from a parent or guardian in the case of children
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Participants - exclusion criteria
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1. Presence of general danger signs or severe falciparum malaria according to the definitions of the World Health Organization (WHO, 2000)
2. Mixed or mono-infection with another Plasmodium species detected by microscopy
3. Presence of severe malnutrition (defined as a child whose growth standard is below -3 z-score, has symmetrical oedema involving at least the feet or has a mid-upper arm circumference less than 110 mm)
4. Presence of febrile conditions due to diseases other than malaria or other known underlying chronic or severe diseases
5. Regular medication, which may interfere with antimalarial pharmacokinetics
6. Received antimalarial drugs in the previous 48 hours
7. History of hypersensitivity reactions or contraindications to any of the medicine(s) used
8. Female patients of child-bearing age, defined as those who menstruate or are aged over 12 years and have not reached the menopause
9. Breastfeeding
10. Splenectomy
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Anticipated start date
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01/06/2010
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Anticipated end date
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01/10/2010
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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40
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Interventions
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Treatment arm 1: oral artesunate 2 mg/kg/day for 3 days followed by oral artemether-lumefantrine (20/120 mg): 1 dose twice daily for three days. Dosing by body weight will be: 1 tablet if less than 15 kg, 2 tablets if 15 - 24 kg, 3 tablets if 25 - 34 kg, and 4 tablets if greater than 35 kg.
Treatment arm 2: oral artesunate 4 mg/kg/day for 3 days followed by oral artemether-lumefantrine (20/120 mg): 1 dose twice daily for three days. Dosing by body weight will be: 1 tablet if less than 15 kg, 2 tablets if 15 - 24 kg, 3 tablets if 25 - 34 kg, and 4 tablets if greater than 35 kg.
The duration of follow-up for both arms is 42 days.
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Primary outcome measure(s)
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Number of patients with PCT greater than 72 hours. If six or more patients per treatment group (n = 20) have PCTs greater than 72 hours the trial will be stopped.
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Secondary outcome measure(s)
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To assess the efficacy of artesunate 2 mg/kg/day and 4 mg/kg/day followed by 3-days artemether-lumefantrine in the treatment of uncomplicated P. falciparum malaria after 42-days follow up. Assessed on the basis of an assessment of the parasitological and clinical outcome of antimalarial treatment according to the latest WHO guidelines.
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Sources of funding
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World Health Organization (WHO) (Switzerland)
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Trial website
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Publications
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Contact name
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Dr
Mayfong
Mayxay
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Address
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Microbiology Laboratory
Mahosot Hospital
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City/town
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Vientiane Captial
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Zip/Postcode
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100
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Country
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Laos
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Sponsor
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University of Oxford (UK)
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Address
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Churchill Hospital
CCVTM
Headington
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City/town
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Oxford
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Zip/Postcode
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OX3 7LJ
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Country
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United Kingdom
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Sponsor website:
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http://www.jr2.ox.ac.uk/ndm/Tropical_Medicine
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Date applied
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21/05/2010
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Last edited
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24/06/2010
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Date ISRCTN assigned
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24/06/2010
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