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
About this trial
This is an interventional treatment trial for Invasive Candidiasis focused on measuring Candidiasis, Invasive Candidiasis, Fungal Infection, Empirical Therapy
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
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
NCT ID
NCT01045798
First Posted
January 7, 2010
Last Updated
February 21, 2017
Sponsor
Merck Sharp & Dohme LLC
Collaborators
Mycoses Study Group
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
Learn more about this trial
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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