Trials Sponsors Conditions Drugs Pricing

Conditions

Antifungal Agents

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (9)

Clinical Cure of Invasive Canididiasis
90 days
Microbiological eradication of Invasive Candidiasis
90 days
30-day mortality
30 days
ICU mortality
90 days
Hospital mortality
90 days
+4 more secondary outcomes

Study Arms (2)

Control Group

NO INTERVENTION

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

1-3 Beta-D-Glucan Group

EXPERIMENTAL

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

Other: duration of antifungal therapy

Interventions

duration of antifungal therapyOther

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

1-3 Beta-D-Glucan Group

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

ICU admission (minimum of 48 hours in ICU with an expected length of stay of at least 48 hours)
Ongoing Mechanical Ventilation

Sponsors & Collaborators

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Otherlead

Study Sites (1)

Gennaro De Pascale

Rome, 00168, Italy

Related Publications (1)

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.
PMID: 32891170DERIVED

Enrollment

120 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: NONE
Purpose: OTHER
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 12, 2017

First Posted

April 18, 2017

Study Start

July 2016

Actual (reported)

Primary Completion

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (9)

Study Arms (2)

Control Group

1-3 Beta-D-Glucan Group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (9)

Study Arms (2)

Control Group

1-3 Beta-D-Glucan Group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations