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
18 Years
N/A
Both
Invasive Candidiasis
Trial Information
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
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Outcome Measure:
Proven and Probable Invasive Candidiasis Based on Modified Mycoses Study Group/European Organization for Research and Treatment of Cancer (MSG/EORTC) Criteria.
Outcome Description:
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.
Outcome Time Frame:
Within 7 days after end of therapy
Safety Issue:
No
Principal Investigator
Luis Ostrosky-Zeichner, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
The University of Texas Health Science Center, Houston
Authority:
United States: Institutional Review Board
Study ID:
MSG-01
NCT ID:
NCT00520234
Start Date:
August 2007
Completion Date:
March 2010
Related Keywords:
- Invasive Candidiasis
- Candida
- Prophylaxis
- High risk adults
- Intensive care unit (ICU)
- Candidiasis
- Candidiasis, Invasive
Name | Location |
|---|---|
| Henry Ford Hospital | Detroit, Michigan 48202 |
| Cooper University Hospital | Camden, New Jersey 08103 |
| University of Colorado | Denver, Colorado 80217 |
| Washington Hospital Center | Washington, District of Columbia 20010 |
| University of Alabama at Birmingham | Birmingham, Alabama 35294-3300 |
| University of Pennsylvania | Philadelphia, Pennsylvania 19104 |
| The Ohio State University | Columbus, Ohio 43210 |
| University of Southern California | Los Angeles, California 90033 |
| Tulane University | New Orleans, Louisiana 70112-2699 |
| Harper University Hospital/ Wayne State | Detroit, Michigan 48201 |
| St. Patrick's Hospital | Missoula, Montana 59802 |
| Medical Center of South Carolina | Charleston, South Carolina 29425 |
