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

NCT ID: NCT01045798

Last Updated: 2017-03-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2012-04-30

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%).

Conditions

Invasive Candidiasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Caspofungin

caspofungin acetate

Group Type: EXPERIMENTAL

Caspofungin acetate

Intervention Type: DRUG

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)

Placebo

normal saline

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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)

Interventions

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)

Intervention Type: 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)

Intervention Type: DRUG

Other Intervention Names

caspofungin; MK-0991; Cancidas®; 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mycoses Study Group

NETWORK

Sponsor Role: collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

2010_502

Identifier Type: OTHER

Identifier Source: secondary_id

0991-067

Identifier Type: -

Identifier Source: org_study_id