สืบค้นงานวิจัย
Defining surrogate endpoints for clinical trials in severe falciparum malaria
Jeeyapant A. - ไม่ระบุหน่วยงาน
ชื่อเรื่อง (EN): Defining surrogate endpoints for clinical trials in severe falciparum malaria
ผู้แต่ง / หัวหน้าโครงการ (EN): Jeeyapant A.
บทคัดย่อ (EN): Clinical trials in severe falciparum malaria require a large sample size to detect clinically meaningful differences in mortality. This means few interventions can be evaluated at any time. Using a validated surrogate endpoint for mortality would provide a useful alternative allowing a smaller sample size. Here we evaluate changes in coma score and plasma lactate as surrogate endpoints for mortality in severe falciparum malaria. Methods Three datasets of clinical studies in severe malaria were re-evaluated: studies from Chittagong, Bangladesh (adults), the African 'AQUAMAT' trial comparing artesunate and quinine (children), and the Vietnamese 'AQ' study (adults) comparing artemether with quinine. The absolute change, relative change, slope of the normalization over time, and time to normalization were derived from sequential measurements of plasma lactate and coma score, and validated for their use as surrogate endpoint, including the proportion of treatment effect on mortality explained (PTE) by these surrogate measures. Results Improvements in lactate concentration or coma scores over the first 24 hours of admission, were strongly prognostic for survival in all datasets. In hyperlactataemic patients in the AQ study (n = 173), lower mortality with artemether compared to quinine closely correlated with faster reduction in plasma lactate concentration, with a high PTE of the relative change in plasma lactate at 8 and 12 hours of 0.81 and 0.75, respectively. In paediatric patients enrolled in the 'AQUAMAT' study with cerebral malaria (n = 785), mortality was lower with artesunate compared to quinine, but this was not associated with faster coma recovery. Conclusions The relative changes in plasma lactate concentration assessed at 8 or 12 hours after admission are valid surrogate endpoints for severe malaria studies on antimalarial drugs or adjuvant treatments aiming at improving the microcirculation. Measures of coma recovery are not valid surrogate endpoints for mortality. © 2017 Jeeyapant et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
บทคัดย่อ: ไม่พบข้อมูลจากหน่วยงานต้นทาง
ภาษา (EN): en
เอกสารแนบ (EN): https://www.scopus.com/inward/record.uri?eid=2-s2.0-85008414445&doi=10.1371%2fjournal.pone.0169307&partnerID=40&md5=19ba30f523baaef7cadd345d73fd6fa2
เผยแพร่โดย (EN): มหาวิทยาลัยมหิดล
คำสำคัญ (EN): ROC Curve
เจ้าของลิขสิทธิ์ (EN): มหาวิทยาลัยมหิดล
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Jeeyapant A.. "Defining surrogate endpoints for clinical trials in severe falciparum malaria". ไม่ระบุหน่วยงาน. ม.ป.ป.

Jeeyapant A.. "Defining surrogate endpoints for clinical trials in severe falciparum malaria". ไม่ระบุหน่วยงาน. ม.ป.ป.. Print.



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Defining surrogate endpoints for clinical trials in severe falciparum malaria
Jeeyapant A.
มหาวิทยาลัยมหิดล
ไม่ระบุวันที่เผยแพร่
Rapid clinical assessment to facilitate the triage of adults with falciparum malaria, a retrospective analysis Artemisinin-resistant Plasmodium falciparum malaria IgE low affinity receptor (CD23) expression, Plasmodium falciparum specific IgE and tumor necrosis factor-alpha production in Thai uncomplicated and severe falciparum malaria patients Sequence variation in Plasmodium falciparum merozoite surface protein-2 is associated with virulence causing severe and cerebral malaria Dysregulation of pulmonary endothelial protein C receptor and thrombomodulin in severe falciparum malaria-associated ARDS relevant to hemozoin Multicentre dose audit for clinical trials of radiation therapy in Asia Inhibition of merozoite invasion and transient de-sequestration by sevuparin in humans with Plasmodium falciparum malaria P. falciparum infection and maternofetal antibody transfer in malaria-endemic settings of varying transmission Perceptions of asymptomatic malaria infection and their implications for malaria control and elimination in Laos Genetic diversity of plasmodium falciparum populations in malaria declining areas of Sabah, East Malaysia
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