Pilot Feasibility Study With Patients Who Are at High Risk For Developing Invasive Candidiasis in a Critical Care Setting (MK-0991-067)
Condition: Invasive Candidiasis
MeSH terms: Candidiasis; Candidiasis, Invasive
Intervention: Caspofungin acetate; Placebo
Intervention description: 70 mg of caspofungin administered intravenously (IV) on Day 1 followed by 50 mg daily for at least 6 additional days (maximum duration study therapy is 14 days); Placebo to caspofungin (normal saline) on Day 1 followed by placebo daily for at least 6 additional days (maximum duration study therapy is 14 days)
Intervention MeSH terms: Caspofungin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Candidiasis; Invasive Candidiasis; Fungal Infection; Empirical Therapy

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.
    

Eligibility 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