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Completed

NCT Number: NCT03117439

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

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

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Key information

Conditions

Antifungal Agents

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gennaro De Pascale

Rome, 00168, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

duration of antifungal therapy

Other

Patients in the study group will stop antifungals in presence of a negative result of Beta Glucan Test

Primary outcomes

  1. Reduction of anti fungal duration in the Beta Glucan group compared with standard empirical approach

    Time frame: First 30 days from enrollment

Secondary outcomes

  1. Clinical Cure of Invasive Canididiasis

    Time frame: 90 days

  2. Microbiological eradication of Invasive Candidiasis

    Time frame: 90 days

  3. 30-day mortality

    Time frame: 30 days

  4. ICU mortality

    Time frame: 90 days

    Any cause ICU mortality within three months from enrollment

  5. Hospital mortality

    Time frame: 90 days

    Any cause hospital mortality within three months from enrollment

  6. Duration of ICU length of stay

    Time frame: 90 days

  7. Duration of mechanical ventilation

    Time frame: 90 days

  8. Number of invasive Candida Infections and Beta-Glucan accuracy

    Time frame: 90 days

  9. Cost evaluation (empirical anti fungal therapy vs. Beta Glucan test)

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Apr 18, 2017
Registry last updated
Aug 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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