Publication: In vivo assessment of drug efficacy against Plasmodium falciparum malaria: Duration of follow-up
Issued Date
2004-11-01
Resource Type
ISSN
00664804
Other identifier(s)
2-s2.0-7244219957
Rights
Mahidol University
Rights Holder(s)
SCOPUS
Bibliographic Citation
Antimicrobial Agents and Chemotherapy. Vol.48, No.11 (2004), 4271-4280
Suggested Citation
Kasia Stepniewska, Walter R.J. Taylor, Mayfong Mayxay, Ric Price, Frank Smithuis, Jean Paul Guthmann, Karen Barnes, Hla Yin Myint, Martin Adjuik, Piero Olliaro, Sasithon Pukrittayakamee, Sornchai Looareesuwan, Tran Tinh Hien, Jeremy Farrar, François Nosten, Nicholas P.J. Day, Nicholas J. White In vivo assessment of drug efficacy against Plasmodium falciparum malaria: Duration of follow-up. Antimicrobial Agents and Chemotherapy. Vol.48, No.11 (2004), 4271-4280. doi:10.1128/AAC.48.11.4271-4280.2004 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/21508
Research Projects
Organizational Units
Authors
Journal Issue
Thesis
Title
In vivo assessment of drug efficacy against Plasmodium falciparum malaria: Duration of follow-up
Other Contributor(s)
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 O 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 (r2= 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.