Overview

Outcomes of Patients Who Fail to Respond to Fluconazole Treatment of Severe Candida Albicans Infections

Status:
Completed
Trial end date:
2009-12-01
Target enrollment:
0
Participant gender:
All
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.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
CPL Associates
Collaborator:
Astellas Pharma US, Inc.
Treatments:
Fluconazole
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