Randomized Study of Caspofungin Prophylaxis Followed by Pre-emptive Therapy for Invasive Candidiasis in the Intensive Care Unit (ICU)

Phase 4

Completed

• Conditions: Invasive Candidiasis
• Interventions: Drug: Caspofungin; Drug: Normal Saline

• Registration Number: NCT00520234
• Lead Sponsor: Mycoses Study Group

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-08-21
• Study First Submitted QC: 2007-08-22
• Study First Posted: 2007-08-23
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Results First Submitted: 2011-03-15
• Status Verified: 2011-04
• Results First Submitted QC: 2011-04-08
• Last Update Submitted: 2011-04-08
• Results First Posted: 2011-05-09
• Last Update Posted: 2011-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 222

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1 prophylaxis	Caspofungin	Caspofungin 50 mg Intravenous (IV) daily up to 28 days of therapy
2 placebo	Normal Saline	Normal Saline 100 cc IV daily

Primary Outcome Measures

Name	Time	Method
Proven and Probable Invasive Candidiasis Based on Modified Mycoses Study Group/European Organization for Research and Treatment of Cancer (MSG/EORTC) Criteria.	Within 7 days after end of therapy	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.

Secondary Outcome Measures

Name	Time	Method
Incidence of Proven Invasive Candidiasis by MSG/ EORTC Criteria.	Within 7 days of end of therapy
All Cause Mortality	Within 7 days of end of therapy
Initiation of Other Antifungals	Within 7 days after end of therapy
Time to Development of Proven or Probable Invasive Candidiasis	Within 7 days after end of therapy
Incidence of Proven and Probable Invasive Fungal Infections Other Than Invasive Candidiasis.	Within 7 days after end of therapy
Time to Beta Glucan Negativity in Pre-emptive Phase.	Within 14 days after end of therapy
Incidence of Complete and Partial Response by Clinical and Microbiological or Serological Evidence for Subjects on the Pre-emptive Therapy Phase.	Within 14 days after end of therapy
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.	Hospital discharge
Subjects Who Discontinue Study Therapy Due to a Drug-related Adverse Event	Up to 14 days after end of therapy
Subjects With 1 or More Serious Drug-related Adverse Event(s)	Up to 14 days after end of therapy

Trial Locations

Locations (12)

University of Southern California; 🇺🇸 Los Angeles, California, United States

The Ohio State University; 🇺🇸 Columbus, Ohio, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

St. Patrick's Hospital; 🇺🇸 Missoula, Montana, United States

Cooper University Hospital; 🇺🇸 Camden, New Jersey, United States

Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

University of Colorado; 🇺🇸 Denver, Colorado, United States

Tulane University; 🇺🇸 New Orleans, Louisiana, United States

Harper University Hospital/ Wayne State; 🇺🇸 Detroit, Michigan, United States

Henry Ford Hospital; 🇺🇸 Detroit, Michigan, United States

Medical Center of South Carolina; 🇺🇸 Charleston, South Carolina, United States