Beta-Glucan Driven vs. Empirical Antifungal Therapy in Critically Ill Patients
NCT ID: NCT03117439
Last Updated: 2018-08-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
120 participants
INTERVENTIONAL
2016-07-31
2018-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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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.
No interventions assigned to this group
1-3 Beta-D-Glucan Group
Patients undergoing anti fungal de-escalation according to 1-3 Beta-D-Glucan results
duration of antifungal therapy
Patients in the study group will stop antifungals in presence of a negative result of Beta Glucan Test
Interventions
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duration of antifungal therapy
Patients in the study group will stop antifungals in presence of a negative result of Beta Glucan Test
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
OTHER
Responsible Party
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Locations
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Gennaro De Pascale
Rome, , Italy
Countries
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References
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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.
Other Identifiers
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100452
Identifier Type: -
Identifier Source: org_study_id
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