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
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