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Caspofungin for the Treatment of Non-blood Candida Infections



Caspofungin for the Treatment of Non-blood Candida Infections

For Condition: Candidiasis
Status: Not yet recruiting
Sponsor(s): Sponsor Name Pending ,
Synopsis: 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 diease and extent of infection.
Details:
Eligibility:
Study Type:  Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 

Location and Contact Information:


Additional Information:
Study ID Numbers:  0404NBCI; 
Study Start Date: 
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00083343

Other Candidiasis Studies:
1. The Safety and Efficacy of Anidulafungin versus Comparator in Patients with Candidemia and Invasive Candidiasis

2. The Safety and Efficacy of Intravenous Anidulafungin as a Treatment for Azole-Refractory Mucosal Candidiasis (FRMC)

3. A Randomized, Prospective, Double-Blind Study Comparing Fluconazole With Placebo for Primary and Secondary Prophylaxis of Mucosal Candidiasis in HIV-Infected Women

4. The Safety and Effectiveness of Intravenous Anidulafungin as a Treatment for Patients with Invasive Candidiasis.

5. A Study to Assess the Effect of Concomitant Administration of Fluconazole on the Clinical Pharmacokinetics of Methadone

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