Pilot Feasibility Study With Patients Who Are at High Risk For Developing Invasive Candidiasis in a Critical Care Setting (MK-0991-067)

• Status: Terminated
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a pilot feasibility study that investigates antifungal therapy with caspofungin in patients at high-risk for developing invasive candidiasis in a critical care setting.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Collaborator: Mycoses Study Group
• Treatments: Caspofungin; Echinocandins

Criteria

Inclusion Criteria:

• Hospitalization for a minimum of 3 days in an ICU and expectation to stay in the ICU for at least another 48 hours

• Meets the following high-risk criteria: Requires mechanical ventilation at the time of study entry; and has a central venous catheter in place at the time of study entry; and is receiving broad spectrum antibiotics at the time of study entry; AND meets at least one of the following criteria: Required parenteral nutrition during the current ICU admission; or required renal dialysis during the current ICU admission; or had major surgery during or within the 7 days before the current ICU admission; or was diagnosed with pancreatitis during or within the 7 days before the current ICU admission; or required systemic steroids or other immunosuppressive agents during or within the 7 days before the current ICU admission

• Meets at least one of the following criteria of suspected infection at the time of study entry or within the 24 hours before study entry: Temperature ≥38° C or ≤36° C (oral equivalent); or hypotension (systolic blood pressure of <90 mm Hg) or significant drop in blood pressure (40 mm Hg) from the participant's normal baseline; or elevated white blood cell count of ≥12,000/mm^3

• Candida is growing in at least one non-sterile culture site collected during the current ICU admission

• Female of childbearing potential has a negative serum or urine pregnancy test before enrollment

Exclusion Criteria:

• Females pregnant or breast feeding

• History of allergy, hypersensitivity, or any serious reaction to caspofungin or another member of the echinocandin class (e.g., micafungin, anidulafungin)

• Neutropenia or expected to develop neutropenia during study therapy

• Diagnosis of acquired immune deficiency syndrome (AIDS), aplastic anemia, or chronic granulomatous disease

• Diagnosis of moderate or severe hepatic insufficiency

• Patient not expected to survive at least 24 hours

• Received systemic (IV or oral) antifungal therapy within 10 days before study entry

• Active diagnosis of proven or probable invasive fungal infection (IFI)

• Currently on or has received an investigational agent within 10 days before study entry

• Any condition or concomitant illness which might confuse the study results or pose additional risk in administering the study therapy