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Clinical Trials/NCT00083343
NCT00083343CompletedPhase 2

A Multicenter, Open, Noncomparative Study to Estimate the Safety, Tolerability, and Efficacy of Caspofungin Acetate in the Treatment of Adults With Invasive Candida Infections (Excluding Patients With Candidemia as the Sole Site of Infection)

Merck Sharp & Dohme LLC0 sites48 target enrollmentStarted: May 2004Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
48
Primary Endpoint
Favorable overall response rate
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Favorable overall response rate

Secondary Outcomes

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

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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