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

Antifungal Agents Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03117439
• Other study ID #: 100452
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: August 2018

Study information

• Verified date: August 2018
• Source: Policlinico Universitario Agostino Gemelli
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Antifungal Agents
• Critical Illness

Intervention

Other:
• duration of antifungal therapy
Patients in the study group will stop antifungals in presence of a negative result of Beta Glucan Test

Locations

Country	Name	City	State
Italy	Gennaro De Pascale	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Policlinico Universitario Agostino Gemelli

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of anti fungal duration in the Beta Glucan group compared with standard empirical approach		First 30 days from enrollment
Secondary	Clinical Cure of Invasive Canididiasis		90 days
Secondary	Microbiological eradication of Invasive Candidiasis		90 days
Secondary	30-day mortality		30 days
Secondary	ICU mortality	Any cause ICU mortality within three months from enrollment	90 days
Secondary	Hospital mortality	Any cause hospital mortality within three months from enrollment	90 days
Secondary	Duration of ICU length of stay		90 days
Secondary	Duration of mechanical ventilation		90 days
Secondary	Number of invasive Candida Infections and Beta-Glucan accuracy		90 days
Secondary	Cost evaluation (empirical anti fungal therapy vs. Beta Glucan test)		30 days