Comparison of Candida Eradication and Serum Cidal Activity of Echinocandins
Information source: Michigan State University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Candidemia
Intervention: micafungin (Drug); Micafungin (Drug); Caspofungin (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Gary E. Stein, Pharm.D. Official(s) and/or principal investigator(s): Gary E Stein, Pharm.D., Principal Investigator, Affiliation: Michigan State University
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.
Clinical Details
Official title: Comparison of Candida Eradication and Serum Cidal Activity of Echinocandins in Patients With Presumptive Candidemia
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Serum Cidal Activity as Tested Against Various Candida Isolates and Reported as Ex-vivo Effect (Log Inhibition of Growth)
Detailed description:
Methods:
Patients - Adult patients with presumptive candidemia. Patients with severe neutropenia
(<500) APACHE II scores > 20, or significant liver disease will be excluded. All will give
written informed consent (Pappas et al. CID. Oct 1, 2007).
Drugs - Patients will receive either CFG: 70 mg loading dose (LD) followed by 50 mg once
daily (qd) (8 patients), MFG: 100 mg qd (8 patients) or MFG: 200 mg qd (8 patients). All
agents will be given by slow IV infusion (MFG will be supplied by Astellas).
Sera - Blood samples will be collected at the end of the infusion (peak) and at 12 h and 24
h (trough) after the beginning of an infusion (day 3-4).
Each patients sera will be tested (MIC and cidal activity) against their own Candida isolate
(if isolated). In addition, recent clinical isolates of C. glabrata will also be tested
against patient sera (time-kill) to verify previous in vitro and animal PD studies (Cota.
AAC. Nov. 2006; Wiederhold. AAC. May 2007).
Results:
- Patient outcome, including Candida eradication, will be documented for each patient by
repeat culture.
- Serum concentrations (lab to be determined) and PK analysis of each echinocandin will
be determined for each patient.
- Serum cidal titers will be measured against each of the Candida isolates for each agent
at each time period. Median and geometric mean Peak and duration of cidal activity
will then be determined and compared.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Adult patients with presumptive candidemia
Exclusion Criteria:
- Patients with severe neutropenia (<500)
- Patients with APACHE II scores > 20
- Patients with severe liver disease
Locations and Contacts
Sparrow Hospital, Lansing, Michigan 48912, United States
Additional Information
Starting date: December 2008
Last updated: February 27, 2012
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