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

NCT01045798 | Terminated Phase 2 Results DMC

• 2 other identifiers: 0991-0672010_502
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Invasive Candidiasis

Keywords

Candidiasis; Invasive Candidiasis; Fungal Infection; Empirical Therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  1 to 14 days

Study Arms (2)

Caspofungin

EXPERIMENTAL

caspofungin acetate

Drug: Caspofungin acetate

Placebo

PLACEBO COMPARATOR

normal saline

Drug: Placebo

Interventions

Caspofungin acetate 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)

Also known as: caspofungin, MK-0991, Cancidas®

Caspofungin

Placebo 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)

Also known as: normal saline

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead
• Mycoses Study Group: collaborator

MeSH Terms

Conditions

Candidiasis, Invasive; Candidiasis; Mycoses

Interventions

Caspofungin; Saline Solution

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections; Invasive Fungal Infections

Intervention Hierarchy (Ancestors)

Lipopeptides; Lipids; Peptides; Amino Acids, Peptides, and Proteins; Echinocandins; Peptides, Cyclic; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Limitations and Caveats

This study was terminated early due to low participant enrollment.

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2010
• First Posted: January 11, 2010
• Study Start: December 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: March 24, 2017
• Results First Posted: May 10, 2013

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will share