Caspofungin Study for Fungal Infections in Adults in Critical Care Settings

• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
• Overall Status: Terminated
• CT.gov ID: NCT00095316
• Collaborator: (none)
• Enrollment: 1,200
• Locations: 26
• Arms: 2
• Duration (Months): 23
• Patients Per Site: 46.2
• Patients Per Site Per Month: 2

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Candidiasis	Drug: Caspofungin; Other: Placebo	Phase 3

Detailed Description

A Randomized, Double-Masked Trial of Caspofungin (50 mg/day) Versus Placebo as Prophylaxis of Invasive Candidiasis in HighRisk Adults in the Critical Care Setting for up to 28 days with observation of primary outcome through 7 days after study therapy. The primary objective of this study is to evaluate the efficacy of caspofungin as prophylaxis for invasive candidiasis in high-risk ICU patients as opposed to those receiving placebo whereas the secondary objectives are as follows: To evaluate the utility of surrogate markers for the diagnosis of invasive candidiasis, to assess the effect of colonization as a risk factor in developing the disease, evaluate the safety of prophylactic caspofungin in subjects who discontinue the study due to drug-related adverse events versus subjects with 1 or more drug-related adverse events and to evaluate the all-cause mortality.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 1200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Prevention
• 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
• Study Start Date: Oct 1, 2004
• Study Completion Date: Sep 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Subjects receive placebo intravenously daily for 28 days	Other: Placebo; Normal saline equivalent to that used to deliver the caspofungin given intravenously as a single daily dose infused over approximately 1 hour for 28 days
Experimental: Caspofungin Subjects receive 50mg/day caspofungin intravenously (IV) for 28 days	Drug: Caspofungin; Caspofungin is an antifungal agent of the echinocandin class of glucan synthase inhibitor. Subjects receive Caspofungin acetate 50mg/day IV for 28 days.

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 .

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama Hospital - Infectious Diseases	Birmingham	Alabama	United States	35249-0001
2	University of Southern California - Infectious Diseases	Los Angeles	California	United States	90089-0121
3	Harbor UCLA Medical Center - Medicine - Infectious Diseases	Torrance	California	United States	90502-2006
4	University of Colorado Hospital - Denver	Denver	Colorado	United States	80220-3706
5	MedStar Washington Hospital Center - Infectious Diseases	Washington	District of Columbia	United States	20010-3017
6	Jackson Memorial Hospital	Miami	Florida	United States	33136-1005
7	Emory University School of Medicine - Infectious Diseases	Atlanta	Georgia	United States	30303-3033
8	Rush University Medical Center	Chicago	Illinois	United States	60612-3808
9	University of Illinois at Chicago College of Medicine - Infectious Diseases	Chicago	Illinois	United States	60612-7300
10	The University of Chicago - Medicine - Infectious Diseases & Global Health	Chicago	Illinois	United States	60637-1447
11	Loyola University - Emergency Facility	Maywood	Illinois	United States	60153-3328
12	Infectious Disease of Indiana, PSC	Indianapolis	Indiana	United States	46260-1992
13	University of Kentucky - UK Albert B Chandler Hospital	Lexington	Kentucky	United States	40536-0001
14	Overton Brooks VA Medical Center	Shreveport	Louisiana	United States	71101-4243
15	Mark Hatfield Clinical Research Center	Bethesda	Maryland	United States	20892-0001
16	Tufts Medical Center - Infectious Diseases Clinic	Boston	Massachusetts	United States	02111-1552
17	University of Michigan - VA Ann Arbor Health Care Systems	Ann Arbor	Michigan	United States	48105-2303
18	Harper University Hospital	Detroit	Michigan	United States	48201-2018
19	Henry Ford Health System - Henry Ford Hospital	Detroit	Michigan	United States	48202-2608
20	University of Mississippi - Infectious Diseases	Jackson	Mississippi	United States	39216-4505
21	Cooper University Hospital - Infectious Diseases	Camden	New Jersey	United States	08103-1505
22	Duke University Medical Center - Duke Clinical Research Institute	Durham	North Carolina	United States	27705-3824
23	Memorial Hermann Hospital	Houston	Texas	United States	77030-1501
24	University of Texas Health Science Center at San Antonio - Infectious Diseases	San Antonio	Texas	United States	78229-3901
25	University of Virginia Primary Health Center - Infectious Diseases and International Health	Charlottesville	Virginia	United States	22908-1340
26	University of Wisconsin Hospital and Clinics - Clinical Science Center - Nephrology	Madison	Wisconsin	United States	53792-0001

Sponsors and Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00095316
• Other Study ID Numbers: 02-042; BAMSG 2-01
• First Posted: Nov 3, 2004
• Last Update Posted: Dec 5, 2014
• Last Verified: Jun 1, 2006

• Keywords provided by , ,: candidiasis, caspofungin, fungal infection, prophylaxis
• Additional relevant MeSH terms: Candidiasis; Caspofungin

Study Results

No Results Posted as of Dec 5, 2014