Candida is the most common fungal pathogen identified in hospitalized patients. This study will seek to enroll adult patients (18 years of age or older) with invasive Candida infections (involving deep tissues and organs). The study will not enroll patients whose only site of Candida infection was the bloodstream. Patients that fulfill all study entry criteria will receive a single daily dose of caspofungin. Caspofungin, an intravenous echinocandin antifungal agent, is already approved for the treatment of invasive candidiasis. The dosage strength and duration of caspofungin will be individualized for each patient based on disease, severity of disease and extent of infection.

Condition	Treatment or Intervention	Phase
Candidiasis	Drug: Caspofungin	Phase II Phase III

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• All patients must have at least 1 positive culture for Candida species obtained from an otherwise sterile, non-blood body site within 96 hours of the study entry.
• The patient must also have clinical evidence of Candida infection (e.g., oral temperature >100 degrees Farenheit, signs of inflammation from infected site, systolic blood presure <90) within 96 hours of study entry.
• The patient must be at least 18 years old, and if a woman of child bearing potential, must have a negative serum or urine pregnancy test sensitive to 25 IU HCG prior to enrollment.

Exclusion Criteria:

• Patients whose only site of Candida infection was the bloodstream.

Toll Free Number      1-888-577-8839 

Alabama
      Call for Information, Birmingham,  Alabama,  35294-0006,  United States; Recruiting
Michigan
      Call for Information, Detroit,  Michigan,  48201,  United States; Recruiting
New Jersey
      Call for Information, Camden,  New Jersey,  08103,  United States; Recruiting
New York
      Call for Information, Rochester,  New York,  14642,  United States; Recruiting
Texas
      Call for Information, Houston,  Texas,  77030-4095,  United States; Recruiting

Study ID Numbers:  0404NBCI
Record last reviewed:  October 2004
Record first received:  May 20, 2004
ClinicalTrials.gov Identifier:  NCT00083343
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-18