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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


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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Page last updated: August 23, 2015

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