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

Study Overview
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Brief Summary
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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

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

Conditions
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Antifungal Agents

Intervention / Treatment
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* Other: duration of antifungal therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>Patients undergoing empirical anti fungal therapy. Interruption of anti fungal treatment will be decided on the basis of standard clinically and microbiologically criteria. | |
| Experimental: 1-3 Beta-D-Glucan Group<br>Patients undergoing anti fungal de-escalation according to 1-3 Beta-D-Glucan results | Other: duration of antifungal therapy<br>* Patients in the study group will stop antifungals in presence of a negative result of Beta Glucan Test<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of anti fungal duration in the Beta Glucan group compared with standard empirical approach |  | First 30 days from enrollment | 

Secondary Outcome Measures

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