Caspofungin for the Treatment of Non-blood Candida Infections (0991-045)

A Multicenter, Open, Noncomparative Study to Estimate the Safety, Tolerability, and Efficacy of Caspofungin Acetate in the Treatment of Adults With Invasive Candida Infections (Excluding Patients With Candidemia as the Sole Site of Infection)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00083343

Enrollment

Registered

2004-05-24

Start date

2004-05-31

Completion date

2006-02-28

Last updated

2017-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Candidiasis

Brief summary

Candida is the most common fungal pathogen identified in hospitalized patients. This study will seek to enroll adult patients (18 years of age or older) with invasive Candida infections (involving deep tissues and organs). The study will not enroll patients whose only site of Candida infection was the bloodstream. Patients that fulfill all study entry criteria will receive a single daily dose of caspofungin. Caspofungin, an intravenous echinocandin antifungal agent, is already approved for the treatment of invasive candidiasis. The dosage strength and duration of caspofungin will be individualized for each patient based on disease, severity of disease and extent of infection.

Interventions

DRUGMK0991, caspofungin acetate/Duration of Treatment: variable

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* All patients must have at least 1 positive culture for Candida species obtained from an otherwise sterile, non-blood body site within 96 hours of the study entry. * The patient must also have clinical evidence of Candida infection (e.g., oral temperature \>100 degrees Fahrenheit, signs of inflammation from infected site, systolic blood pressure \<90) within 96 hours of study entry. * The patient must be at least 18 years old, and if a woman of child bearing potential, must have a negative serum or urine pregnancy test sensitive to 25 IU HCG prior to enrollment.

Exclusion criteria

* Patients whose only site of Candida infection was the bloodstream.

Design outcomes

Primary

Measure	Time frame
Favorable overall response rate	—

Secondary

Measure	Time frame
Favorable overall response rate on Day 10 of caspofungin therapy	—
Occurance of relapse during the 12 week follow-up period following the completion of all antifungal therapy	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026