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    Apr 11, 2021
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    In vivo assessment of drug efficacy against Plasmodium falciparum malaria: duration of follow-up.

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    Authors
    Stepniewska, K
    Taylor, W R J
    Mayxay, M
    Price, R
    Smithuis, F
    Guthmann, J P
    Barnes, K
    Myint, H Y
    Adjuik, M
    Olliaro, P
    Pukrittayakamee, S
    Looareesuwan, S
    Hien, T T
    Farrar, J
    Nosten, F
    Day, N P J
    White, N J
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    Affiliation
    Faculty of Tropical Medicine, Mahidol University, 420/6 Rajvithi Rd., Bangkok 10400, Thailand.
    Issue Date
    2004-11
    
    Metadata
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    Journal
    Antimicrobial Agents and Chemotherapy
    Abstract
    To determine the optimum duration of follow-up for the assessment of drug efficacy against Plasmodium falciparum malaria, 96 trial arms from randomized controlled trials (RCTs) with follow-up of 28 days or longer that were conducted between 1990 and 2003 were analyzed. These trials enrolled 13,772 patients, and participating patients comprised 23% of all patients enrolled in RCTs over the past 40 years; 61 (64%) trial arms were conducted in areas where the rate of malaria transmission was low, and 58 (50%) trial arms were supported by parasite genotyping to distinguish true recrudescences from reinfections. The median overall failure rate reported was 10% (range, 0 to 47%). The widely used day 14 assessment had a sensitivity of between 0 and 37% in identifying treatment failures and had no predictive value. Assessment at day 28 had a sensitivity of 66% overall (28 to 100% in individual trials) but could be used to predict the true failure rate if either parasite genotyping was performed (r(2) = 0.94) or if the entomological inoculation rate was known. In the assessment of drug efficacy against falciparum malaria, 28 days should be the minimum period of follow-up.
    URI
    http://hdl.handle.net/10144/56122
    DOI
    10.1128/AAC.48.11.4271-4280.2004
    PubMed ID
    15504852
    Type
    Article
    Language
    en
    ISSN
    0066-4804
    Sponsors
    Epicentre
    ae974a485f413a2113503eed53cd6c53
    10.1128/AAC.48.11.4271-4280.2004
    Scopus Count
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    Malaria

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