Misclassification of Drug Failure inPlasmodium falciparumClinical Trials in Southeast Asia | Zendy

Jonathan J. Juliano | Zendy; Frédéric Ariey | Zendy; Rithy Sem | Zendy; Noppadon Tangpukdee | Zendy; Srivicha Krudsood | Zendy; Carol A. Olson | Zendy; Sornchai Looareesuwan | Zendy; William O. Rogers | Zendy; Chansuda Wongsrichanalai | Zendy; Steven R. Meshnick | Zendy

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Misclassification of Drug Failure inPlasmodium falciparumClinical Trials in Southeast Asia

Author(s) -

Jonathan J. Juliano,

Frédéric Ariey,

Rithy Sem,

Noppadon Tangpukdee,

Srivicha Krudsood,

Carol A. Olson,

Sornchai Looareesuwan,

William O. Rogers,

Chansuda Wongsrichanalai,

Steven R. Meshnick

Publication year - 2009

Publication title -

the journal of infectious diseases

Language(s) - English

Resource type - Journals

SCImago Journal Rank - 2.69

H-Index - 252

eISSN - 1537-6613

pISSN - 0022-1899

DOI - 10.1086/600892

Subject(s) - heteroduplex , polymerase chain reaction , plasmodium falciparum , clinical trial , drug , medicine , malaria , biology , virology , pharmacology , immunology , gene , genetics

Most trials of antimalarials occur in areas in which reinfections are possible. For Plasmodium falciparum, reinfections are distinguished from recrudescences by polymerase chain reaction analysis of 3 polymorphic genes. However, the validity of this approach has never been rigorously tested. We tested for misclassification in 6 patients from clinical trials in Thailand and Cambodia who were classified as being reinfected by the standard polymerase chain reaction protocol. Using heteroduplex tracking assays and direct DNA sequencing, we found that 5 (83%) of 6 patients were misclassified. Misclassification in this manner overestimates the efficacy of antimalarials and delays the recognition of decreasing therapeutic efficacy, thus delaying potential changes in policy.

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