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

Information source: Mycoses Study Group
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Invasive Candidiasis

Intervention: Caspofungin (Drug); Normal Saline (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Mycoses Study Group

Official(s) and/or principal investigator(s):
Luis Ostrosky-Zeichner, MD, Principal Investigator, Affiliation: The University of Texas Health Science Center, Houston
Peter G Pappas, MD, Principal Investigator, Affiliation: Mycoses Study Group

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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

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

Secondary outcome:

Incidence of Proven Invasive Candidiasis by MSG/ EORTC Criteria.

All Cause Mortality

Initiation of Other Antifungals

Time to Development of Proven or Probable Invasive Candidiasis

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

Time to Beta Glucan Negativity in Pre-emptive Phase.

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

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.

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

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

Eligibility

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

Criteria:

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 and Contacts

University of Alabama at Birmingham, Birmingham, Alabama 35124, United States

University of Southern California, Los Angeles, California 29425, United States

University of Colorado, Denver, Colorado 80262, United States

Washington Hospital Center, Washington, District of Columbia 20010, United States

Tulane University, New Orleans, Louisiana 70112, United States

Harper University Hospital/ Wayne State, Detroit, Michigan 48201, United States

Henry Ford Hospital, Detroit, Michigan 48202, United States

St. Patrick's Hospital, Missoula, Montana 59802, United States

Cooper University Hospital, Camden, New Jersey 08103, United States

The Ohio State University, Columbus, Ohio 43210, United States

University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States

Medical Center of South Carolina, Charleston, South Carolina 29425, United States

Additional Information

Related publications:

Diekema DJ, Messer SA, Brueggemann AB, Coffman SL, Doern GV, Herwaldt LA, Pfaller MA. Epidemiology of candidemia: 3-year results from the emerging infections and the epidemiology of Iowa organisms study. J Clin Microbiol. 2002 Apr;40(4):1298-302.

Jarvis WR. Epidemiology of nosocomial fungal infections, with emphasis on Candida species. Clin Infect Dis. 1995 Jun;20(6):1526-30. Review.

Goodman JL, Winston DJ, Greenfield RA, Chandrasekar PH, Fox B, Kaizer H, Shadduck RK, Shea TC, Stiff P, Friedman DJ, et al. A controlled trial of fluconazole to prevent fungal infections in patients undergoing bone marrow transplantation. N Engl J Med. 1992 Mar 26;326(13):845-51.

Denning DW. Echinocandins: a new class of antifungal. J Antimicrob Chemother. 2002 Jun;49(6):889-91. Review.

Starting date: August 2007
Last updated: April 8, 2011

Page last updated: August 20, 2015

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