Pilot Feasibility Study With Patients Who Are at High Risk For Developing Invasive Candidiasis in a Critical Care Setting (MK-0991-067 AM1) - Full Text View

Purpose

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.

Condition	Intervention	Phase
Invasive Candidiasis	Drug: Caspofungin acetate Drug: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Critical Care Fungal Infections Yeast Infections

Drug Information available for: Caspofungin Caspofungin acetate

U.S. FDA Resources

Further study details as provided by Merck:

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. [ Time Frame: 1 to 14 days ] [ Designated as safety issue: No ]
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.

Enrollment:	15
Study Start Date:	December 2010
Study Completion Date:	April 2012
Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Caspofungin caspofungin acetate	Drug: Caspofungin acetate 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) Other Names: caspofungin MK-0991 Cancidas®
Placebo Comparator: Placebo normal saline	Drug: Placebo 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) Other Name: normal saline

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%).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Merck
ClinicalTrials.gov Identifier:	NCT01045798 History of Changes
Other Study ID Numbers:	0991-067, 2010_502
Study First Received:	January 7, 2010
Results First Received:	March 26, 2013
Last Updated:	March 26, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck:

Candidiasis
Invasive Candidiasis
Fungal Infection
Empirical Therapy

Additional relevant MeSH terms:

Candidiasis
Candidiasis, Invasive
Mycoses
Caspofungin
Echinocandins

Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013