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

MSG-04 (Also Known as Merck Caspofungin Protocol 067): A Pilot, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Caspofungin Empirical Therapy for Invasive Candidiasis in High-Risk Patients in the Critical Care Setting

Sponsors

Lead Sponsor: Merck Sharp & Dohme Corp.

Collaborator: Mycoses Study Group

Source Merck Sharp & Dohme Corp.
Brief 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.

Detailed 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%).

Overall Status Terminated
Start Date December 2010
Completion Date April 2012
Primary Completion Date April 2012
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
The Proportion of Patients Discontinued From Study Therapy to be Treated With Empirical Antifungal Therapy Outside of the Context of the Study. 1 to 14 days
Enrollment 15
Condition
Intervention

Intervention Type: Drug

Intervention Name: Caspofungin acetate

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)

Arm Group Label: Caspofungin

Intervention Type: Drug

Intervention Name: Placebo

Description: 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)

Arm Group Label: Placebo

Other Name: normal saline

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Verification Date

February 2017

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Caspofungin

Type: Experimental

Description: caspofungin acetate

Label: Placebo

Type: Placebo Comparator

Description: normal saline

Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov

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