Randomized Study of Caspofungin Prophylaxis Followed by Pre-emptive Therapy for Invasive Candidiasis in the Intensive Care Unit (ICU) (MSG-01)

Mycoses Study Group

Status and phase

Completed

Phase 4

Conditions

Invasive Candidiasis

Treatments

Drug: Normal Saline

Drug: Caspofungin

Study type

Interventional

Funder types

NETWORK

Industry

Identifiers

NCT00520234

MSG-01

Details and patient eligibility

About

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.

Enrollment

222 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.