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

Merck Sharp & Dohme (MSD)

Status and phase

Terminated

Phase 2

Conditions

Invasive Candidiasis

Treatments

Drug: Placebo

Drug: Caspofungin acetate

Study type

Interventional

Funder types

NETWORK

Industry

Identifiers

NCT01045798

2010_502 (Other Identifier)

0991-067

Details and patient eligibility

About

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.

Full description

Hypothesis: In high-risk non-neutropenic participants in the ICU, the proportion of participants discontinued from study therapy in order to be empirically treated with antifungal therapy for suspected candidiasis outside of the context of this protocol is less than 20% (i.e., the upper bound of the 95% confidence interval for the observed proportion is less than 20%).

Enrollment

15 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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