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Sponsors and Collaborators: |
CPL Associates Astellas Pharma US, Inc. |
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Information provided by: | CPL Associates |
ClinicalTrials.gov Identifier: | NCT00721487 |
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.
Condition | Intervention |
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C. Albicans Infection |
Drug: Fluconazole |
Study Type: | Observational |
Study Design: | Case-Only, 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 |
Estimated Enrollment: | 30 |
Study Start Date: | July 2008 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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Fluconazole
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.
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Drug: Fluconazole
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
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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.
Ages Eligible for Study: | 4 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
This is a multi-center study of adult and pediatric patients hospitalized with severe infection caused by C.
albicans. An announcement of this case series collection study will be sent to our ongoing list of primary care practitioners, hospitalists, specialists in infectious diseases, pulmonologists, clinical pharmacists, and other investigators throughout the USA.
Inclusion Criteria:
Medical history, clinical signs and symptoms, and radiological findings consistent with severe C. albicans infection. For example, the criteria for pneumonia are as follows:
4. Admitted to a hospital or ICU for treatment of a severe infection.
Exclusion Criteria:
United States, New York | |
CPL Associates,LLC | |
Buffalo, New York, United States, 14226 |
Principal Investigator: | Jerome Schentag, Pharm.D. | CPL Associates, LLC |
Principal Investigator: | Joseph Paladino, Pharm.D. | CPL Associates, LLC |
Responsible Party: | CPL Associates, LLC ( Jerome J Schentag, Pharm.D. ) |
Study ID Numbers: | MYCA-8F16 |
Study First Received: | July 22, 2008 |
Last Updated: | January 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00721487 History of Changes |
Health Authority: | United States: Institutional Review Board |
C. albicans fluconazole |
Fluconazole Anti-Infective Agents Antifungal Agents Torulopsis |
Fluconazole Anti-Infective Agents Communicable Diseases Therapeutic Uses |
Antifungal Agents Infection Pharmacologic Actions |