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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

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

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

Time Frame

1 to 14 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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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