Outcomes of Patients Who Fail to Respond to Fluconazole Treatment of Severe Candida Albicans Infections
Completed
Conditions studied: Fungal Infection by Site
In brief
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.
Key facts
- Study ID
- NCT00721487
- Run by
- CPL Associates
- People needed
- 28
- Starts
- 2008-07-01
- Expected to finish
- 2009-12-01
- Last updated by the study team
- 2014-07-23
Who can join
Age: 4 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
- Admitted to a hospital or ICU for treatment of a severe infection.
You may not qualify if…
- Pregnant or lactating women
- Cystic fibrosis
- Life expectancy <3 months from underlying disease
- Underlying lung carcinoma
Where it is running
- CPL Associates,LLC — Buffalo, New York, United States
Full record on ClinicalTrials.gov
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