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Master Thesis

Évaluation médico-économique d’une PCR multiplexe pour le diagnostic rapide des bactériémies et fongémies

Abstract : Bacteraemia and fungemia remain diseases with a high mortality rate despite recent progress. Indeed, one of the areas for improvement is the reduction of the diagnostic delay, which is still often high, given the need to transfer positive blood culture bottles to agar medium. The HEMOFAST clinical study conducted at the CHUGA and presented here, aims to evaluate the medico-economic impact of a new generation of syndromic multiplex PCR, the ePlex® PCR developed by GenMark and usable directly on positive blood culture bottles, after a direct microscopic examination. This PCR comprises several panels, depending on the results of the direct examination, which make it possible to identify, in 1,5 hours, 56 species or genera of bacteria and micromycetes as well as 10 resistance genes. The primary endpoint of the study is the time to optimised treatment inferior or equal to twelve hours (T12h), compared between the two arms of the study: an arm receiving the "usual" treatment in force in our centre and an arm benefiting in addition from the ePlex rapid test. The results of the intermediate analysis presented in this thesis show a significant contribution of this rapid test, since an optimised antibiotic therapy was reached at T12h for 63.55% of the patients in the "usual" group compared to 86.67% in the group with PCR. This difference was statistically significant (p<0.001), which led to the early termination of the study. In addition, of the 106 episodes of bacteraemia or fungemia investigated during the course of the study, the ePlex multiplex PCR allowed identification of the species involved and reliable detection of resistance determinants for 92 of them, i.e. a proportion of 87%. As no false positive results were produced, the specificity for all targets included in these panels was 100%. These encouraging results will be complemented by the definitive results in the final data analysis of the study.
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Master Thesis
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Submitted on : Thursday, October 28, 2021 - 4:21:51 PM
Last modification on : Saturday, October 30, 2021 - 3:33:29 AM
Long-term archiving on: : Saturday, January 29, 2022 - 7:49:32 PM


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  • HAL Id : dumas-03407771, version 1
  • PPN : 258193735


Arthur Devès. Évaluation médico-économique d’une PCR multiplexe pour le diagnostic rapide des bactériémies et fongémies. Sciences pharmaceutiques. 2021. ⟨dumas-03407771⟩



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