Outcomes of Patients Who Fail to Respond to Fluconazole Treatment of Severe Candida Albicans Infections
Information source: CPL Associates
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: C. Albicans Infection
Intervention: Fluconazole (Drug)
Phase: N/A
Status: Not yet recruiting
Sponsored by: CPL Associates Official(s) and/or principal investigator(s):
Jerome Schentag, Pharm.D., Principal Investigator, Affiliation: CPL Associates, LLC
Joseph Paladino, Pharm.D., Principal Investigator, Affiliation: CPL Associates, LLC
Overall contact:
Jenna Sunderlin, Phone: 716-839-4931, Ext: 220, Email: studies@cplassociates.com
Summary
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.
Clinical Details
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 design: Case-Only, Retrospective
Detailed description:
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.
Eligibility
Minimum age: 4 Years.
Maximum age: 85 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Medical history, clinical signs and symptoms, and radiological findings consistent
with severe C. albicans infection. For example, the criteria for pneumonia are as
follows:
1. A core body temperature >38C [100. 4F] or <36. 1 C [97oF] or leukocytosis (blood
leukocyte count >10,000 cells/mm3) or bandemia (>10% bands).
2. Chest radiographic examination that shows a new or progressive infiltrate,
consolidation, cavitation, or pleural effusion.
3. Rales, dullness to percussion, or decreased breath sounds on physical examination
of the chest, new onset of purulent sputum, or change in character of sputum.
2. A positive culture must demonstrate the presence of C. albicans, isolated from a
properly obtained respiratory or blood sample, collected within 72 hours of admission
to a hospital. All patients with respiratory cultures must produce sputum with Gram
stain analysis indicating the relative absence of contaminating oropharyngeal squamous
cells and the presence of a significant number of WBCs and morphologically distinct
bacteria. Fluconazole sensitivity testing results must be available for the initial
C. albicans isolate.
3. Must have received, and failed to respond to, at least 4 days of treatment with
fluconazole.
4. Admitted to a hospital or ICU for treatment of a severe infection.
Exclusion Criteria:
1. Pregnant or lactating women
2. Cystic fibrosis
3. Life expectancy <3 months from underlying disease
4. Underlying lung carcinoma
Locations and Contacts
Jenna Sunderlin, Phone: 716-839-4931, Ext: 220, Email: studies@cplassociates.com
CPL Associates,LLC, Buffalo, New York 14226, United States
Additional Information
Sponsors website
Starting date: July 2008
Last updated: July 23, 2008
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