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

Primary Purpose

Invasive Candidiasis

Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Caspofungin acetate
Placebo
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Invasive Candidiasis focused on measuring Candidiasis, Invasive Candidiasis, Fungal Infection, Empirical Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Caspofungin

    Placebo

    Arm Description

    caspofungin acetate

    normal saline

    Outcomes

    Primary Outcome Measures

    The Proportion of Patients Discontinued From Study Therapy to be Treated With Empirical Antifungal Therapy Outside of the Context of the Study.
    The feasibility of conducting a major randomized study of caspofungin for empirical therapy for invasive candidiasis in high-risk non-neutropenic intensive care unit (ICU) participants was to be assessed by the incidence of study therapy discontinuations due to investigators choosing to treat participants with empirical antifungal therapy outside of the context of this protocol. Study drug was administered for a minimum of 7 days to a maximum of 14 days provided participants had no evidence of confirmed breakthrough invasive Candida infection while receiving study drug.

    Secondary Outcome Measures

    Full Information

    First Posted
    January 7, 2010
    Last Updated
    February 21, 2017
    Sponsor
    Merck Sharp & Dohme LLC
    Collaborators
    Mycoses Study Group
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01045798
    Brief Title
    Pilot Feasibility Study With Patients Who Are at High Risk For Developing Invasive Candidiasis in a Critical Care Setting (MK-0991-067)
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Terminated
    Why Stopped
    Low participant enrollment: 15 enrolled of 114 planned
    Study Start Date
    December 2010 (undefined)
    Primary Completion Date
    April 2012 (Actual)
    Study Completion Date
    April 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC
    Collaborators
    Mycoses Study Group

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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%).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Invasive Candidiasis
    Keywords
    Candidiasis, Invasive Candidiasis, Fungal Infection, Empirical Therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    15 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Caspofungin
    Arm Type
    Experimental
    Arm Description
    caspofungin acetate
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    normal saline
    Intervention Type
    Drug
    Intervention Name(s)
    Caspofungin acetate
    Other Intervention Name(s)
    caspofungin, MK-0991, Cancidas®
    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)
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Other Intervention Name(s)
    normal saline
    Intervention 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)
    Primary Outcome Measure Information:
    Title
    The Proportion of Patients Discontinued From Study Therapy to be Treated With Empirical Antifungal Therapy Outside of the Context of the Study.
    Description
    The feasibility of conducting a major randomized study of caspofungin for empirical therapy for invasive candidiasis in high-risk non-neutropenic intensive care unit (ICU) participants was to be assessed by the incidence of study therapy discontinuations due to investigators choosing to treat participants with empirical antifungal therapy outside of the context of this protocol. Study drug was administered for a minimum of 7 days to a maximum of 14 days provided participants had no evidence of confirmed breakthrough invasive Candida infection while receiving study drug.
    Time Frame
    1 to 14 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php

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

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