Caspofungin for the Treatment of Non-blood Candida Infections (0991-045)

Phase 2

Completed

• Conditions: Candidiasis

• Registration Number: NCT00083343
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-05
• Study First Submitted: 2004-05-20
• Study First Submitted QC: 2004-05-21
• Study First Posted: 2004-05-24
• Primary Completion: 2006-02
• Study Completion: 2006-02
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-20
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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 Fahrenheit, signs of inflammation from infected site, systolic blood pressure <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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Favorable overall response rate

Secondary Outcome Measures

Name	Time	Method
Favorable overall response rate on Day 10 of caspofungin therapy
Occurance of relapse during the 12 week follow-up period following the completion of all antifungal therapy