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ISRCTN
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ISRCTN15314870
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ClinicalTrials.gov identifier
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Public title
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Levamisole hydrochloride as adjunctive therapy in falciparum malaria
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Scientific title
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Acronym
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N/A
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Serial number at source
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077166
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Study hypothesis
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Cytoadherence of parasitised erythrocytes to microvascular endothelium is the pathological hallmark of falciparum malaria. In vitro studies show that levamisole, a specific alkaline-phosphatase inhibitor, decreases adhesion of parasitised erythrocytes to CD36. This pilot study aims to examine whether this happens in vivo.
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Lay summary
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Ethics approval
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Oxford Tropical Research Ethics Committee gave approval on the 1st June 2006 (ref: 007-06)
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Study design
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Randomised controlled trial
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Countries of recruitment
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Thailand
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Disease/condition/study domain
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Falciparum malaria
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Participants - inclusion criteria
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1. The patient or attending relative is able and willing to give informed consent - the proposed consent form and information sheets are attached and will be translated into Burmese
2. Uncomplicated falciparum malaria
3. Patients aged 16 to 65 years old, either sex
4. No contraindications to levamisole, quinine or doxycycline therapy, like documented allergies to any of the drugs
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Participants - exclusion criteria
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1. Patient or relatives unable or unwilling to give informed consent
2. Previous antimalarial treatment within one week of admission
3. Pregnancy
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Anticipated start date
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01/10/2003
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Anticipated end date
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01/10/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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40 (as of 01/10/2006 21 patients were recruited)
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Interventions
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Patients admitted to Mae Sot Hospital with uncomplicated falciparum malaria will be randomised to either adjunctive treatment with a single dose of 150 mg oral levamisole hydrochloride, or no adjunctive treatment. Antimalarial treatment will be oral quinine and doxycycline.
Peripheral blood parasitaemia and parasite stages will be assessed frequently. If sequestration of parasitised erythrocytes is reduced, an initial increase in peripheral blood parasitaemia and appearance of more mature parasites in the peripheral blood can be expected.
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Primary outcome measure(s)
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Sequential assessment of peripheral blood parasitaemia and parasite stages.
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Secondary outcome measure(s)
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No secondary outcome measures
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Sources of funding
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The Wellcome Trust (UK) (grant ref: 077166)
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Trial website
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Publications
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Contact name
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Prof
Nicholas J
White
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Address
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Wellcome Unit
Faculty of Tropical Medicine
420/6 Rajvithi Road
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City/town
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Bangkok
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Zip/Postcode
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10400
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Country
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Thailand
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Tel
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+66 (0)2 3549172
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Fax
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+66 (0)2 3549169
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Email
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nickw@tropmedres.ac
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Sponsor
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University of Oxford (UK)
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Address
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CCVTM
Churchill Hospital
Old Road
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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Tel
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+44 (0)1865 857433
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Fax
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+44 (0)1865 857407
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Email
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ccvtm@clinical-medicine.oxford.ac.uk
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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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12/09/2005
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Last edited
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04/02/2009
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Date ISRCTN assigned
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14/10/2005
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