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

Not Applicable

Completed

• Conditions: Antifungal Agents
• Interventions: Other: duration of antifungal therapy

• Registration Number: NCT03117439
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2017-04-12
• Study First Submitted QC: 2017-04-12
• Study First Posted: 2017-04-18
• Primary Completion: 2018-06
• Status Verified: 2018-08
• Study Completion: 2018-08
• Last Update Submitted: 2018-08-28
• Last Update Posted: 2018-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1-3 Beta-D-Glucan Group	duration of antifungal therapy	Patients undergoing anti fungal de-escalation according to 1-3 Beta-D-Glucan results

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Gennaro De Pascale; 🇮🇹 Rome, Italy