Title
Randomized Study of Caspofungin Prophylaxis Followed by Pre-emptive Therapy for Invasive Candidiasis in the Intensive Care Unit (ICU)
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
Phase 4Lead Sponsor
Mycoses Study GroupStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Invasive CandidiasisIntervention/Treatment
caspofungin sodium chloride ...Study Participants
222Adults 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.
50 mg IV daily
100 cc IV daily
Caspofungin 50 mg Intravenous (IV) daily up to 28 days of therapy
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.
| Event Type | Organ System | Event Term | Prophylaxis | Placebo |
|---|
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 Measure Data Not Reported
Outcome Measure Data Not Reported
Outcome Measure Data Not Reported
Outcome Measure Data Not Reported
Outcome Measure Data Not Reported
Outcome Measure Data Not Reported
Outcome Measure Data Not Reported
Outcome Measure Data Not Reported
