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Journal Article > Research

In vivo assessment of drug efficacy against Plasmodium falciparum malaria: duration of follow-up

Stepniewska K, Taylor WRJ, Mayxay M, Price RN, Smithuis FM, Guthmann JP, Barnes KI, Myint HY, Adjuik M, Olliaro PL, Pukrittayakamee S, Looareesuwan S, Hien TT, Farrar J, Nosten F, Day NPJ, White NJ
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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.
Subject Area
malaria
DOI
10.1128/AAC.48.11.4271-4280.2004
Published Date
01-Nov-2004
PubMed ID
15504852
Languages
English
Journal
Antimicrobial Agents and Chemotherapy
Volume / Issue / Pages
Volume 48, Issue 11
Issue Date
01-Nov-2004
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