Caspofungin for the Treatment of Non-blood Candida Infections (0991-045)
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)
4 other identifiers
interventional
48
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started May 2004
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2004
CompletedFirst Submitted
Initial submission to the registry
May 20, 2004
CompletedFirst Posted
Study publicly available on registry
May 24, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2006
CompletedFebruary 23, 2017
February 1, 2017
1.8 years
May 20, 2004
February 20, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Favorable overall response rate
Secondary Outcomes (2)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patients whose only site of Candida infection was the bloodstream.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Petrovic J, Ngai A, Bradshaw S, Williams-Diaz A, Taylor A, Sable C, Vuocolo S, Kartsonis N. Efficacy and safety of caspofungin in solid organ transplant recipients. Transplant Proc. 2007 Dec;39(10):3117-20. doi: 10.1016/j.transproceed.2007.10.003.
PMID: 18089335BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Merck Sharp & Dohme LLC
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2004
First Posted
May 24, 2004
Study Start
May 1, 2004
Primary Completion
February 1, 2006
Study Completion
February 1, 2006
Last Updated
February 23, 2017
Record last verified: 2017-02