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
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 |
Verified date | August 2018 |
Source | Policlinico Universitario Agostino Gemelli |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
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 |
Country | Name | City | State |
---|---|---|---|
Italy | Gennaro De Pascale | Rome |
Lead Sponsor | Collaborator |
---|---|
Policlinico Universitario Agostino Gemelli |
Italy,
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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