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

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Completed

Conditions: Antifungal Agents

Treatments: Other: duration of antifungal therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03117439

100452

Details and patient eligibility

About

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

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Control Group

No Intervention group

Description:

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 group

Description:

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

Treatment:

Other: duration of antifungal therapy