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dc.contributor.authorStepniewska, K
dc.contributor.authorTaylor, W R J
dc.contributor.authorMayxay, M
dc.contributor.authorPrice, R
dc.contributor.authorSmithuis, F
dc.contributor.authorGuthmann, J P
dc.contributor.authorBarnes, K
dc.contributor.authorMyint, H Y
dc.contributor.authorAdjuik, M
dc.contributor.authorOlliaro, P
dc.contributor.authorPukrittayakamee, S
dc.contributor.authorLooareesuwan, S
dc.contributor.authorHien, T T
dc.contributor.authorFarrar, J
dc.contributor.authorNosten, F
dc.contributor.authorDay, N P J
dc.contributor.authorWhite, N J
dc.date.accessioned2009-03-18T09:07:44Z
dc.date.available2009-03-18T09:07:44Z
dc.date.issued2004-11
dc.identifier.citationIn vivo assessment of drug efficacy against Plasmodium falciparum malaria: duration of follow-up. 2004, 48 (11):4271-80 Antimicrob. Agents Chemother.en
dc.identifier.issn0066-4804
dc.identifier.pmid15504852
dc.identifier.doi10.1128/AAC.48.11.4271-4280.2004
dc.identifier.urihttp://hdl.handle.net/10144/56122
dc.description.abstractTo 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.
dc.description.sponsorshipEpicentreen
dc.language.isoenen
dc.rightsPublished by American Society for Microbiology Archived on this site with permission and copyright by the American Society for Microbiologyen
dc.subject.meshAlgorithmsen
dc.subject.meshAnimalsen
dc.subject.meshAntimalarialsen
dc.subject.meshDrug Resistanceen
dc.subject.meshEndpoint Determinationen
dc.subject.meshFollow-Up Studiesen
dc.subject.meshGenotypeen
dc.subject.meshHumansen
dc.subject.meshMalaria, Falciparumen
dc.subject.meshPlasmodium falciparumen
dc.subject.meshPredictive Value of Testsen
dc.subject.meshRandomized Controlled Trials as Topicen
dc.subject.meshRecurrenceen
dc.subject.meshRetrospective Studiesen
dc.subject.meshReverse Transcriptase Polymerase Chain Reactionen
dc.subject.meshTime Factorsen
dc.subject.meshTreatment Failureen
dc.titleIn vivo assessment of drug efficacy against Plasmodium falciparum malaria: duration of follow-up.en
dc.typeArticleen
dc.contributor.departmentFaculty of Tropical Medicine, Mahidol University, 420/6 Rajvithi Rd., Bangkok 10400, Thailand.en
dc.identifier.journalAntimicrobial Agents and Chemotherapyen
refterms.dateFOA2019-03-04T12:31:31Z
html.description.abstractTo 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.


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