Comparison of Candida Eradication and Serum Cidal Activity of Echinocandins
1 other identifier
interventional
21
1 country
1
Brief Summary
The purpose of this pharmacokinetic (PK) and pharmacodynamic (PD) study is: To study the rate and duration of serum cidal activity of caspofungin (CFG) and micafungin (MFG) against Candida isolates from the subject and against Candida glabrata with varying degrees of caspofungin susceptibilities. This investigation will provide clinicians information supporting the use of caspofungin and micafungin in situations where Candida strains may be a cause of infection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Dec 2008
1 active site
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
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 6, 2009
CompletedFirst Posted
Study publicly available on registry
February 9, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedResults Posted
Study results publicly available
February 24, 2012
CompletedApril 30, 2024
April 1, 2024
1.4 years
February 6, 2009
January 23, 2012
April 27, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Serum Cidal Activity as Tested Against Various Candida Isolates and Reported as Ex-vivo Effect (Log Inhibition of Growth)
Serum cidal activity of serum collected at different timepoints from the patients will be tested against various Candida isolates and the ex-vivo effect reported as log inhibition (logrithmic measurement of the decrease in microbiological growth). These Candida isolates had a range of minimum inhibitory concentrations (MIC) to Caspofungin (C) and Micafungin (M).
Pre-treatment, 1.5 hour (h), 12 h and 24 h after receiving the drug
Study Arms (3)
micafungin 100
ACTIVE COMPARATORPatients receive Micafungin 100 mg qd
micafungin 200
ACTIVE COMPARATORPatients receive 200 mg Micafungin qd
Caspofungin
ACTIVE COMPARATORPatients receive caspofungin 70 mg LD followed by 50 mg qd
Interventions
70 mg LD followed by 50 mg qd by slow IV infusion for 24 h
Eligibility Criteria
You may qualify if:
- Adult patients with presumptive candidemia
You may not qualify if:
- Patients with severe neutropenia (\<500)
- Patients with APACHE II scores \> 20
- Patients with severe liver disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gary E. Stein, Pharm.D.lead
- Astellas Pharma US, Inc.collaborator
Study Sites (1)
Sparrow Hospital
Lansing, Michigan, 48912, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Gary E.Stein, Pharm.D.
- Organization
- Michigan State University
Study Officials
- PRINCIPAL INVESTIGATOR
Gary E Stein, Pharm.D.
Michigan State University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
February 6, 2009
First Posted
February 9, 2009
Study Start
December 1, 2008
Primary Completion
May 1, 2010
Study Completion
May 1, 2010
Last Updated
April 30, 2024
Results First Posted
February 24, 2012
Record last verified: 2024-04