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Randomized Study of Caspofungin Prophylaxis Followed by Pre-emptive Therapy for Invasive Candidiasis in the Intensive Care Unit (ICU) | Clinical Trials | Clareo Health

COMPLETEDPHASE4

Randomized Study of Caspofungin Prophylaxis Followed by Pre-emptive Therapy for Invasive Candidiasis in the Intensive Care Unit (ICU)

A Randomized, Double-blind, Placebo Controlled Trial of Caspofungin Prophylaxis Followed by Pre-emptive Therapy for Invasive Candidiasis in High-risk Adults in the Critical Care Setting

NCT00520234•Mycoses Study Group

View on ClinicalTrials.gov

Summary

Adults admitted to intensive care units are at risk for a variety of complications. Infections due to the fungus called candida are of particular concern. The study will test the possibility that caspofungin, a new therapy for fungal infections, can successfully reduce the rate of candida infections in subjects at risk. It will also test if caspofungin is useful in treating subjects for this disease when diagnosed using a new blood test that is performed twice weekly, permitting earlier diagnosis than current practice standards.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Non-pregnant \>18 yrs of age
•Subjects admitted to ICU during the preceding 3 days and expected to stay in the ICU for at least another 48 hours.Subjects can be enrolled on days 3-5 of ICU admission.
•Subjects meeting the clinical prediction rule

Exclusion Criteria

•Subjects with an allergy/intolerance to caspofungin or echinocandin analog
•absolute neutrophil count \<500/mm3 at study entry or likely to develop such a count during therapy
•acquired immunodeficiency syndrome, aplastic anemia or chronic granulomatous disease
•moderate or severe hepatic insufficiency
•subjects who are pregnant or lactating
•unlikely to survive \< 24 hours
•subjects who have received systemic antifungal therapy within 10 days prior to study entry
•Documented active proven or probable invasive fungal infection upon enrollment
•previously enrolled in this study
•Currently on another investigational agent or have received an investigational agent within 10 days prior to study entry.

Locations (12)

University of Alabama at Birmingham

Birmingham, Alabama, United States

University of Southern California

Los Angeles, California, United States

University of Colorado

Denver, Colorado, United States

Washington Hospital Center

Washington D.C., District of Columbia, United States

Tulane University

New Orleans, Louisiana, United States

Harper University Hospital/ Wayne State

Detroit, Michigan, United States

Henry Ford Hospital

Detroit, Michigan, United States

St. Patrick's Hospital

Missoula, Montana, United States

Cooper University Hospital

Camden, New Jersey, United States

The Ohio State University

Columbus, Ohio, United States

Key Dates

Start Date

August 1, 2007

Primary Completion Date

March 1, 2010

Completion Date

March 1, 2010

Last Updated

May 9, 2011

Enrollment

222

ACTUAL participants

Conditions

Invasive Candidiasis

Interventions

Caspofungin

DRUG

Normal Saline

DRUG

Early Discontinuation of Empirical Antifungal Therapy and Biomarkers

NCT03538912

Invasive Candidiasis

View study

COMPLETED

NOBICS - NOvel BIomarker In Invasive CandidiasiS/Candida Sepsis

NCT02801682

Invasive Candidiasis

View study

COMPLETEDPHASE1

Pharmacokinetics of Micafungin in Children on Extracorporeal Membrane Oxygenation

NCT01666769

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 9, 2011Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Randomized Study of Caspofungin Prophylaxis Followed by Pre-emptive Therapy for Invasive Candidiasis in the Intensive Care Unit (ICU)

Inclusion Criteria

Exclusion Criteria

Early Discontinuation of Empirical Antifungal Therapy and Biomarkers

NOBICS - NOvel BIomarker In Invasive CandidiasiS/Candida Sepsis

Pharmacokinetics of Micafungin in Children on Extracorporeal Membrane Oxygenation

A Multicenter, Randomized, Double-Blind, Comparative Study to Evaluate the Safety, Tolerability, and Efficacy of 2 Dosing Regimens of an Antifungal Drug in the Treatment of Fungal Infections in Adults (0991-801)(COMPLETED)

CRITIC - Treatment of Candidemia and Invasive Candidiasis