Phase 4 N=21 Randomized Treatment

Comparison of Candida Eradication and Serum Cidal Activity of Echinocandins

Candidemia

Bottom Line

View on ClinicalTrials.gov: NCT00839540 ↗

Enrolled (actual)

Serious AEs

9.5%

Results posted

Feb 2012

Primary outcome: Primary: Serum Cidal Activity as Tested Against Various Candida Isolates and Reported as Ex-vivo Effect (Log Inhibition of Growth) — 3; 0.5; 0; 3 Log inhibition

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: micafungin (Drug); Caspofungin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Gary E. Stein, Pharm.D.
Primary completion: May 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Serum Cidal Activity as Tested Against Various Candida Isolates and Reported as Ex-vivo Effect (Log Inhibition of Growth)	3; 0.5; 0; 3; 1.5; 0.5	—

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.

Eligibility Criteria

Inclusion Criteria

Adult patients with presumptive candidemia

Exclusion Criteria

Patients with severe neutropenia ( 20
Patients with severe liver disease

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Data sourced from ClinicalTrials.gov (NCT00839540). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.