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Comparison of Candida Eradication and Serum Cidal Activity of Echinocandins

This study has been completed.
Sponsor:
Collaborator:
Astellas Pharma US, Inc.
Information provided by (Responsible Party):
Gary E. Stein, Pharm.D., Michigan State University
ClinicalTrials.gov Identifier:
NCT00839540
First received: February 6, 2009
Last updated: February 27, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Candidemia
 Drug: micafungin
Drug: Micafungin
Drug: Caspofungin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Candida Eradication and Serum Cidal Activity of Echinocandins in Patients With Presumptive Candidemia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Michigan State University:

Primary Outcome Measures:
  • Serum Cidal Activity as Tested Against Various Candida Isolates and Reported as Ex-vivo Effect (Log Inhibition of Growth) [ Time Frame: Pre-treatment, 1.5 hour (h), 12 h and 24 h after receiving the drug ] [ Designated as safety issue: No ]

    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).



Enrollment: 21
Study Start Date: December 2008
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: micafungin 100
Patients receive Micafungin 100 mg qd
 Drug: micafungin
100 mg qd by slow IV infusion for 24 h
Other Name: Micamine
Active Comparator: micafungin 200
Patients receive 200 mg Micafungin qd
 Drug: Micafungin
200 mg qd by slow IV infusion for 24 h
Other Name: Micamine
Active Comparator: Caspofungin
Patients receive caspofungin 70 mg LD followed by 50 mg qd
 Drug: Caspofungin
70 mg LD followed by 50 mg qd by slow IV infusion for 24 h
Other Name: Cancidas

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00839540

Locations
United States, Michigan
Sparrow Hospital
Lansing, Michigan, United States, 48912
Sponsors and Collaborators
Gary E. Stein, Pharm.D.
Astellas Pharma US, Inc.
Investigators
Principal Investigator: Gary E Stein, Pharm.D. Michigan State University
  More Information

No publications provided

Responsible Party: Gary E. Stein, Pharm.D., Professor of Medicine, Michigan State University
ClinicalTrials.gov Identifier: NCT00839540     History of Changes
Other Study ID Numbers: PA-07-004
Study First Received: February 6, 2009
Results First Received: January 23, 2012
Last Updated: February 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Michigan State University:
candidemia
echinocandin
micafungin
caspofungin

Additional relevant MeSH terms:
Candidemia
Fungemia
Sepsis
Infection
Candidiasis, Invasive
Candidiasis
Mycoses
Systemic Inflammatory Response Syndrome
Inflammation
 Pathologic Processes
Caspofungin
Echinocandins
Micafungin
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013