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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03117439
Other study ID # 100452
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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