Status:
COMPLETED
Outcomes of Patients Who Fail to Respond to Fluconazole Treatment of Severe Candida Albicans Infections
Lead Sponsor:
CPL Associates
Collaborating Sponsors:
Astellas Pharma US, Inc.
Conditions:
Fungal Infection by Site
Eligibility:
All Genders
4-85 years
Brief 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 fluc...
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 fluc...
Eligibility Criteria
Inclusion
- Medical history, clinical signs and symptoms, and radiological findings consistent with severe C. albicans infection. For example, the criteria for pneumonia are as follows:
- 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).
- Chest radiographic examination that shows a new or progressive infiltrate, consolidation, cavitation, or pleural effusion.
- 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.
- 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.
- 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
- Pregnant or lactating women
- Cystic fibrosis
- Life expectancy \<3 months from underlying disease
- Underlying lung carcinoma
Key Trial Info
Start Date :
July 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00721487
Start Date
July 1 2008
End Date
December 1 2009
Last Update
July 23 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
CPL Associates,LLC
Buffalo, New York, United States, 14226