Beta-Glucan Driven vs. Empirical Antifungal Therapy in Critically Ill Patients

(1-3)-Beta-D-Glucan Driven vs. Empirical Antifungal Therapy in High Risk Critically Ill Patients A Randomized Study

This study is aimed to compare the duration of standard anti fungal therapy in high risk ICU patients with a strategy driven by BetaDGlucan test result

Study Overview

• Status: Completed
• Conditions: Antifungal Agents
• Intervention / Treatment: Other: duration of antifungal therapy

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, 00168
    • Gennaro De Pascale

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ICU admission (minimum of 48 hours in ICU with an expected length of stay of at least 48 hours)
• Ongoing Mechanical Ventilation
• Presence of CVC
• Sepsis/Septic Shock development while receiving broad spectrum antibiotics
• Positivity of Candida Score or Candida Colonization Index in absence of septic shock

Exclusion Criteria:

• Complicated Candida Infection
• Already ongoing anti fungal therapy
• Beta Glucan test not available
• Absence of informed consent
• Immunesuppressive status (long-term immunesuppresive or steroids therapy; AIDS; WBC <1000/mmc or neutrophils <500/mmc)
• Pregnancy
• Already enrolled in other interventional studies

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; Patients undergoing empirical anti fungal therapy. Interruption of anti fungal treatment will be decided on the basis of standard clinically and microbiologically criteria.
Experimental: 1-3 Beta-D-Glucan Group; Patients undergoing anti fungal de-escalation according to 1-3 Beta-D-Glucan results	Other: duration of antifungal therapy; Patients in the study group will stop antifungals in presence of a negative result of Beta Glucan Test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Reduction of anti fungal duration in the Beta Glucan group compared with standard empirical approach	First 30 days from enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Cure of Invasive Canididiasis		90 days
Microbiological eradication of Invasive Candidiasis		90 days
30-day mortality		30 days
ICU mortality	Any cause ICU mortality within three months from enrollment	90 days
Hospital mortality	Any cause hospital mortality within three months from enrollment	90 days
Duration of ICU length of stay		90 days
Duration of mechanical ventilation		90 days
Number of invasive Candida Infections and Beta-Glucan accuracy		90 days
Cost evaluation (empirical anti fungal therapy vs. Beta Glucan test)		30 days

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Publications and helpful links

General Publications

• De Pascale G, Posteraro B, D'Arrigo S, Spinazzola G, Gaspari R, Bello G, Montini LM, Cutuli SL, Grieco DL, Di Gravio V, De Angelis G, Torelli R, De Carolis E, Tumbarello M, Sanguinetti M, Antonelli M. (1,3)-beta-D-Glucan-based empirical antifungal interruption in suspected invasive candidiasis: a randomized trial. Crit Care. 2020 Sep 5;24(1):550. doi: 10.1186/s13054-020-03265-y.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): August 1, 2018

Study Registration Dates

• First Submitted: April 12, 2017
• First Submitted That Met QC Criteria: April 12, 2017
• First Posted (Actual): April 18, 2017

Study Record Updates

• Last Update Posted (Actual): August 31, 2018
• Last Update Submitted That Met QC Criteria: August 28, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; Antifungal Agents; Clotrimazole; Miconazole
• Other Study ID Numbers: 100452

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No