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

NCT00721487 | Completed

• 1 other identifier: MYCA-8F16
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

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 fluconazole failures are more frequently associated with fluconazole-resistant or fluconazole-susceptible strains of C. albicans.

Conditions

Fungal Infection by Site

Keywords

C. albicans; fluconazole

Study Arms (1)

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.

Drug: Fluconazole

Interventions

Fluconazole DRUG

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

Fluconazole

Eligibility Criteria

• Age: 4 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

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

Sponsors & Collaborators

• CPL Associates: lead
• Astellas Pharma US, Inc.: collaborator

Study Sites (1)

CPL Associates,LLC

Buffalo, New York, 14226, United States

Location

MeSH Terms

Interventions

Fluconazole

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jerome Schentag, Pharm.D.

  CPL Associates, LLC

  PRINCIPAL INVESTIGATOR

• Joseph Paladino, Pharm.D.

  CPL Associates, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: CEO

Study Record Dates

• First Submitted: July 22, 2008
• First Posted: July 24, 2008
• Study Start: July 1, 2008
• Primary Completion: October 1, 2009
• Study Completion: December 1, 2009
• Last Updated: July 23, 2014

Record last verified: 2014-07

Locations

US (1)