Candidiasis Clinical Trial
Official title:
A Randomized, Double-Masked Trial of Caspofungin Versus Placebo as Prophylaxis of Invasive Candidiasis in High-Risk Adults in the Critical Care Setting
Adults admitted to intensive care units are at risk for a variety of complications. One of the most frequent complications is the development of new infections. Infections due to a fungus called Candida are of particular concern. This study will test the possibility that caspofungin, a new therapy for fungal infections, may reduce the rate of Candida infections in subjects at risk.
Status | Terminated |
Enrollment | 1200 |
Est. completion date | September 2006 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: Non-pregnant subjects >/= 18 years of age; admission to the ICU during the preceding 3 days (minimum of 2 days in ICU) and expected to stay in the ICU a minimum of 2 additional days; subjects must have at least 1 of the following: received at least one other dose of any systemic antibiotic on any one of the ICU days before study entry and continue to receive antibiotics at the time of enrollment, and/or presence of a central venous catheter at the time of enrollment and for one additional day during the current ICU stay, and at least 2 of the following: use of total parenteral nutrition on any of Days 1-4 of ICU stay; any type of dialysis on any of Days 1-4 of ICU stay; any in-patient surgery done under general anesthesia or epidural block in the 7 days prior to or on ICU admission*; pancreatitis (documented by computed tomography (CT) scan or lipase >1,000 u/L) in the 7 days prior to or on ICU admission; more than 1 dose of systemic steroids (prednisone equivalent dose >/=20 mg per dose) in the 7 days prior to or on ICU admission; and/or use of more than 1 dose of other systemic immunosuppressive agents (such as azathioprine, tacrolimus, sirolimus, mycophenolate, monoclonal antibodies, and tumor necrosis factor [TNF] immunomodulators) in the 7 days prior to or on ICU admission. - Excludes placement of vascular catheters. Exclusion Criteria: Subjects with an allergy or intolerance to caspofungin or other echinocandin analog; absolute neutrophil count <500/mm3 at entry or likely to develop such a count during therapy; diagnosis of HIV, aplastic anemia, or chronic granulomatous disease; moderate or severe hepatic insufficiency as defined by a Child Pugh score of 7 or greater or cirrhosis due to any cause; pregnancy or breastfeeding; subjects unlikely to survive more than 2 days; subjects who have received systemic antifungal therapy within 7 days prior to study entry; subjects with documented active, proven, or probable invasive fungal infection within 7 days prior to study entry; subjects previously enrolled into this trial; subjects currently receiving another investigational agent or who have received an investigational agent within the 7 days prior to study entry; subjects in the ICU 5 or more days prior to enrollment into this study . |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan - VA Ann Arbor Health Care Systems | Ann Arbor | Michigan |
United States | Emory University School of Medicine - Infectious Diseases | Atlanta | Georgia |
United States | Mark Hatfield Clinical Research Center | Bethesda | Maryland |
United States | University of Alabama Hospital - Infectious Diseases | Birmingham | Alabama |
United States | Tufts Medical Center - Infectious Diseases Clinic | Boston | Massachusetts |
United States | Cooper University Hospital - Infectious Diseases | Camden | New Jersey |
United States | University of Virginia Primary Health Center - Infectious Diseases and International Health | Charlottesville | Virginia |
United States | Rush University Medical Center | Chicago | Illinois |
United States | The University of Chicago - Medicine - Infectious Diseases & Global Health | Chicago | Illinois |
United States | University of Illinois at Chicago College of Medicine - Infectious Diseases | Chicago | Illinois |
United States | University of Colorado Hospital - Denver | Denver | Colorado |
United States | Harper University Hospital | Detroit | Michigan |
United States | Henry Ford Health System - Henry Ford Hospital | Detroit | Michigan |
United States | Duke University Medical Center - Duke Clinical Research Institute | Durham | North Carolina |
United States | Memorial Hermann Hospital | Houston | Texas |
United States | Infectious Disease of Indiana, PSC | Indianapolis | Indiana |
United States | University of Mississippi - Infectious Diseases | Jackson | Mississippi |
United States | University of Kentucky - UK Albert B Chandler Hospital | Lexington | Kentucky |
United States | University of Southern California - Infectious Diseases | Los Angeles | California |
United States | University of Wisconsin Hospital and Clinics - Clinical Science Center - Nephrology | Madison | Wisconsin |
United States | Loyola University - Emergency Facility | Maywood | Illinois |
United States | Jackson Memorial Hospital | Miami | Florida |
United States | University of Texas Health Science Center at San Antonio - Infectious Diseases | San Antonio | Texas |
United States | Overton Brooks VA Medical Center | Shreveport | Louisiana |
United States | Harbor UCLA Medical Center - Medicine - Infectious Diseases | Torrance | California |
United States | MedStar Washington Hospital Center - Infectious Diseases | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) |
United States,
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT01982071 -
A Study to Evaluate the Efficacy and Safety of Micafungin Against Invasive Candidiasis or Candidemia
|
Phase 4 | |
Completed |
NCT02391532 -
Effect of Probiotic Bacteria on Oral Candida in Frail Elderly
|
N/A | |
Completed |
NCT01447407 -
Effect of Adjuvant & Route of Administration on Safety & Immunogenicity of NDV-3 Vaccine
|
Phase 1 | |
Not yet recruiting |
NCT00889356 -
Evaluate Efficacy, Tolerability & Safety of Combination of Clindamycin and Ketoconazole for the Treatment of Mixed-Type Vaginosis, Bacterial Vaginosis and Candidiasis
|
Phase 3 | |
Completed |
NCT00105144 -
Study of Micafungin in Patients With Invasive Candidiasis or Candidemia
|
Phase 3 | |
Completed |
NCT00163111 -
A Clinical Study Intended To Compare Treatment With Voriconazole To Treatment With Amphotericin Followed By Fluconazole In Patients With Candidemia, A Serious Fungus Infection Of The Blood.
|
Phase 3 | |
Completed |
NCT00138502 -
Funguria in Hospitalized Patients
|
||
Not yet recruiting |
NCT04502277 -
Bioavailability of Flucanazole
|
Early Phase 1 | |
Completed |
NCT03203551 -
Clinical and Laboratorial Evaluation of the Desinfection Solutions in Candida Species From Total Prostheses and Palate of Total Edentulous.
|
N/A | |
Completed |
NCT05044156 -
Investigation of the Relationship Between Salivary Histatine-5 Level and Vaginal Candidiasis in Women
|
||
Completed |
NCT01322698 -
Staging Candidiasis in ICU Patients
|
N/A | |
Terminated |
NCT01092832 -
A Study Of The Safety, Tolerability And Effective Of Voriconazole For The Treatment Of Serious Candida Infection And Candida Infection Of The Throat In Pediatric Patients
|
Phase 3 | |
Completed |
NCT04122560 -
Fluconazole Pharmacokinetics, Including Bioavailability, in Obese Subjects After an Intravenous and Oral Administration
|
Phase 4 | |
Completed |
NCT02641717 -
Validity of Patient-Collected Wet Mounts
|
N/A | |
Recruiting |
NCT01253954 -
A Multicenter Observational Study of Invasive Candida Infections Among ICU Patients in China
|
N/A | |
Completed |
NCT00797420 -
Pharmacokinetics (PK) Study of a Fluconazole Loading Dose in Infants and Toddlers
|
Phase 1 | |
Completed |
NCT00734539 -
Fluconazole Prophylaxis for the Prevention of Candidiasis in Infants Less Than 750 Grams Birthweight
|
Phase 3 | |
Completed |
NCT00001937 -
Comparing the Effectiveness of Fluconazole and a New Medicine (FK463) in Preventing Fungal Infections in Bone Marrow Transplant Patients
|
Phase 3 | |
Completed |
NCT02666716 -
Pharmacokinetics of Fluconazole IV as Prophylaxis or Therapy to ICU Patients
|
||
Terminated |
NCT00692783 -
Incidence of Oral Candidiasis, Prevalence of C. Dubliniensis in HIV Patients and In-vitro Azole Susceptibility
|
N/A |