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    Apr 19, 2021
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    Supervised versus unsupervised intake of six-dose artemether-lumefantrine for treatment of acute, uncomplicated Plasmodium falciparum malaria in Mbarara, Uganda: a randomised trial.

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    Authors
    Piola, P
    Fogg, C
    Bajunirwe, F
    Biraro, S
    Grandesso, F
    Ruzagira, E
    Babigumira, J
    Kigozi, I
    Kiguli, J
    Kyomuhendo, J
    Ferradini, L
    Taylor, W R J R J
    Checchi, F
    Guthmann, J P
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    Affiliation
    Epicentre, 8 rue Saint-Sabin, 75011 Paris, France. uganda@epicentre.msf.org
    Issue Date
    2005-04-23
    
    Metadata
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    Journal
    Lancet
    Abstract
    BACKGROUND: The six-dose regimen of artemether-lumefantrine is effective and is among combination therapies prioritised to replace antimalarials that no longer work in Africa. However, its effectiveness has not been assessed in the field, and could be compromised by poor adherence, incorrect timing of doses, and insufficient intake of fatty foods with every dose. Our aim, therefore, was to assess the effectiveness of artemether-lumefantrine prescribed under routine outpatient conditions, compared with its efficacy when given under supervision to inpatients with acute uncomplicated falciparum malaria. METHODS: We did a randomised trial to compare the efficacy, safety, and pharmacokinetics of artemether-lumefantrine when given in a supervised (all doses observed with fatty-food intake; n=313) or unsupervised (first dose supervised followed by outpatient treatment with nutritional advice; n=644) setting to patients of all ages (weight >10 kg) with acute, uncomplicated falciparum malaria in Mbarara, Uganda. Our primary endpoint was 28 day, PCR-adjusted, parasitological cure rate. Analysis was by intention to treat and evaluability analysis. FINDINGS: 38 patients were lost to follow-up and one withdrew consent. Day-28 cure rates were 97.7% (296 of 303) and 98.0% (603 of 615) in the supervised and unsupervised groups, respectively. We recorded 15 non-severe, drug-related adverse events, all of which resolved. INTERPRETATION: Artemether-lumefantrine has a high cure rate irrespective of whether given under supervision with food or under conditions of routine clinic practice. If used as first-line treatment, artemether-lumefantrine could make a substantial contribution to malaria control in Africa, though cost is an issue.
    Publisher
    Elsevier
    URI
    http://hdl.handle.net/10144/18247
    DOI
    10.1016/S0140-6736(05)66416-1
    PubMed ID
    15850630
    Additional Links
    http://www.thelancet.com
    Language
    en
    ISSN
    1474-547X
    ae974a485f413a2113503eed53cd6c53
    10.1016/S0140-6736(05)66416-1
    Scopus Count
    Collections
    Malaria

    entitlement

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