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

Phase 4CompletedNCT00520234

Mycoses Study Group222 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

222

Conditions

Invasive Candidiasis

Interventions

Caspofungin

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

...and 2 more locations

Outcomes

Primary Outcomes

Proven and Probable Invasive Candidiasis Based on Modified Mycoses Study Group/European Organization for Research and Treatment of Cancer (MSG/EORTC) Criteria.

Modified MSG/EORTC criteria for the diagnosis of fungal infections: Proven invasive candidiasis is defined as candidemia, Candida cultured from a sterile site, or histopathological evidence of candida infection. Probable invasive candidiasis is defined as 2 consecutive positive beta glucan levels in the presence of signs and symptoms of infection.

Time frame: Within 7 days after end of therapy

Secondary Outcomes

Incidence of Proven Invasive Candidiasis by MSG/ EORTC Criteria.

Time frame: Within 7 days of end of therapy

All Cause Mortality

Time frame: Within 7 days of end of therapy

Initiation of Other Antifungals

Time frame: Within 7 days after end of therapy

Time to Development of Proven or Probable Invasive Candidiasis

Time frame: Within 7 days after end of therapy

Incidence of Proven and Probable Invasive Fungal Infections Other Than Invasive Candidiasis.

Time frame: Within 7 days after end of therapy

Time to Beta Glucan Negativity in Pre-emptive Phase.

Time frame: Within 14 days after end of therapy

Incidence of Complete and Partial Response by Clinical and Microbiological or Serological Evidence for Subjects on the Pre-emptive Therapy Phase.

Time frame: Within 14 days after end of therapy

Hospital Metrics (to be Evaluated Separately for Prophylaxis and Pre-emptive Therapy Phases); Length of Stay in the Hospital, Length of Stay in the ICU, and the Costs Data for the ICU Stay and the Hospitalization, if Available.

Time frame: Hospital discharge

Subjects Who Discontinue Study Therapy Due to a Drug-related Adverse Event

Time frame: Up to 14 days after end of therapy

Subjects With 1 or More Serious Drug-related Adverse Event(s)

Time frame: Up to 14 days after end of therapy