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
1 other identifier
interventional
120
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2016
CompletedFirst Submitted
Initial submission to the registry
April 12, 2017
CompletedFirst Posted
Study publicly available on registry
April 18, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2018
CompletedAugust 31, 2018
August 1, 2018
1.9 years
April 12, 2017
August 28, 2018
Conditions
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 INTERVENTIONPatients 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
EXPERIMENTALPatients undergoing anti fungal de-escalation according to 1-3 Beta-D-Glucan results
Interventions
Patients in the study group will stop antifungals in presence of a negative result of Beta Glucan Test
Eligibility Criteria
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
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
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
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 1, 2016
Primary Completion
June 1, 2018
Study Completion
August 1, 2018
Last Updated
August 31, 2018
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will not share