Fungal Infection by Site Clinical Trial
Official title:
A Case Series of Investigator-Identified Fluconazole Failures: Outcome Characterization of Patients Who Fail to Respond to Fluconazole Treatment of Severe Infections Caused by Candida Albicans
The primary aims of this study are to identify and characterize the immediate consequences of patients who fail fluconazole treatment during the treatment of severe infection, and to determine if fluconazole failures are more frequently associated with fluconazole-resistant or fluconazole-susceptible strains of C. albicans.
The primary aims of this study are to identify and characterize the immediate consequences
of patients who fail fluconazole treatment during the treatment of severe infection, and to
determine if fluconazole failures are more frequently associated with fluconazole-resistant
or fluconazole-susceptible strains of C. albicans (i.e. does in vitro resistance matter?).
Perhaps the breakpoints are not correct and need to be changed, as has recently happened
with vancomycin.
A third objective is to calculate fluconazole PK/PD parameters such as AUIC, and compare the
calculated AUIC values of patients who fail with fluconazole-susceptible vs
fluconazole-resistant isolates. Specifically for fluconazole, the question here is whether
dose matters, and can aggressive dosing offset higher MICs. Thus in all cases, we will also
determine the AUIC of fluconazole in order to fully characterize the impact of dose chosen
on the outcomes of treated patients who fail to respond to fluconazole. The clinical,
microbiological, and pharmacoeconomic outcomes of patients who fail fluconazole therapy and
are subsequently hospitalized with severe infections caused by C. albicans will be
documented and described.
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Observational Model: Case-Only, Time Perspective: Retrospective