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

Primary Purpose

Antifungal Agents

Status

Completed

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

duration of antifungal therapy

About this trial

This is an interventional other trial for Antifungal Agents

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Gennaro De Pascale

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group

1-3 Beta-D-Glucan Group

Arm Description

Patients undergoing empirical anti fungal therapy. Interruption of anti fungal treatment will be decided on the basis of standard clinically and microbiologically criteria.

Patients undergoing anti fungal de-escalation according to 1-3 Beta-D-Glucan results

Outcomes

Primary Outcome Measures

Reduction of anti fungal duration in the Beta Glucan group compared with standard empirical approach

Secondary Outcome Measures

Clinical Cure of Invasive Canididiasis

Microbiological eradication of Invasive Candidiasis

30-day mortality

ICU mortality

Any cause ICU mortality within three months from enrollment

Hospital mortality

Any cause hospital mortality within three months from enrollment

Duration of ICU length of stay

Duration of mechanical ventilation

Number of invasive Candida Infections and Beta-Glucan accuracy

Cost evaluation (empirical anti fungal therapy vs. Beta Glucan test)

Full Information

NCT ID

NCT03117439

First Posted

April 12, 2017

Last Updated

August 28, 2018

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

1. Study Identification

Unique Protocol Identification Number

NCT03117439

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Completed

Study Start Date

July 2016 (Actual)

Primary Completion Date

June 2018 (Actual)

Study Completion Date

August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Antifungal Agents

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control Group

Arm Type

No Intervention

Arm Description

Patients undergoing empirical anti fungal therapy. Interruption of anti fungal treatment will be decided on the basis of standard clinically and microbiologically criteria.

Arm Title

1-3 Beta-D-Glucan Group

Arm Type

Experimental

Arm Description

Patients undergoing anti fungal de-escalation according to 1-3 Beta-D-Glucan results

Intervention Type

Other

Intervention Name(s)

duration of antifungal therapy

Intervention Description

Patients in the study group will stop antifungals in presence of a negative result of Beta Glucan Test

Primary Outcome Measure Information:

Title

Reduction of anti fungal duration in the Beta Glucan group compared with standard empirical approach

Time Frame

First 30 days from enrollment

Secondary Outcome Measure Information:

Title

Clinical Cure of Invasive Canididiasis

Time Frame

90 days

Title

Microbiological eradication of Invasive Candidiasis

Time Frame

90 days

Title

30-day mortality

Time Frame

30 days

Title

ICU mortality

Description

Any cause ICU mortality within three months from enrollment

Time Frame

90 days

Title

Hospital mortality

Description

Any cause hospital mortality within three months from enrollment

Time Frame

90 days

Title

Duration of ICU length of stay

Time Frame

90 days

Title

Duration of mechanical ventilation

Time Frame

90 days

Title

Number of invasive Candida Infections and Beta-Glucan accuracy

Time Frame

90 days

Title

Cost evaluation (empirical anti fungal therapy vs. Beta Glucan test)

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Gennaro De Pascale

City

Rome

ZIP/Postal Code

00168

Country

Italy

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32891170

Citation

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.

Results Reference

derived

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

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