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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


Phase 4
18 Years
N/A
Not Enrolling
Both
Invasive Candidiasis

Thank you

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