Outcomes of Patients Who Fail to Respond to Fluconazole Treatment of Severe Candida Albicans Infections
|Study Design:||Observational Model: Case-Only
Time Perspective: Retrospective
|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|
|Study Start Date:||July 2008|
|Study Completion Date:||December 2009|
|Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
30 evaluable patients hospitalized with severe infection caused by C. albicans, documented by standard clinical signs, symptoms, and radiology, and having failed at least four days of fluconazole therapy.
Patients hospitalized with severe infection caused by C. albicans, documented by standard clinical signs, symptoms, and radiology, and having failed at least four days of fluconazole therapy
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00721487
|United States, New York|
|Buffalo, New York, United States, 14226|
|Principal Investigator:||Jerome Schentag, Pharm.D.||CPL Associates, LLC|
|Principal Investigator:||Joseph Paladino, Pharm.D.||CPL Associates, LLC|