Antifungal Agents
Conditions
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
Interventions
OTHERduration of antifungal therapy
Patients in the study group will stop antifungals in presence of a negative result of Beta Glucan Test
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of anti fungal duration in the Beta Glucan group compared with standard empirical approach | First 30 days from enrollment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Microbiological eradication of Invasive Candidiasis | 90 days | — |
| 30-day mortality | 30 days | — |
| ICU mortality | 90 days | Any cause ICU mortality within three months from enrollment |
| Hospital mortality | 90 days | Any cause hospital mortality within three months from enrollment |
| Clinical Cure of Invasive Canididiasis | 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 | — |
| Duration of ICU length of stay | 90 days | — |
Countries
Italy
Outcome results
None listed