Clinical Trial: A B-D-Glucan Driven Antifungal Stewardship Approach for Invasive Candidiasis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A B-D-Glucan Driven Antifungal Stewardship Approach to Manage Empirical Therapy in Patients at Very High Risk for Invasive Candidiasis: a Randomized Controlled Trial

Brief Summary:

This is a multicenter, prospective, open-label, randomized trial. Patients with severe abdominal condition developing severe sepsis or septic shock and receiving broad spectrum antibiotic and antifungal treatment will be randomized (1:1) to:

  1. discontinue antifungal treatment based on negative (<80 pg/ml) result of 1,3 beta-d-glucan performed on day 0,3,6 and 10
  2. continue antifungal treatment according with attending physician's decision.

Detailed Summary:

Primary objective:

Our objective is to establish whether a strategy based on beta-d-glucan (BG) assessment could achieve reduced antifungal consumption in patients with severe abdominal condition developing severe sepsis and septic shock without any impact on the outcome Secondary objectives i) Assess the accuracy of BG in the diagnosis of invasive candidiasis (IC) in in critically ill patients with a severe abdominal condition who develop severe sepsis or septic shock.

ii) Describe the changes over the time of BG value according with colonization status, infection or none the aforementioned events.

Material and Methods Study design: a multicenter, open label, randomized trial Population: all the patients with a severe abdominal condition who develop a severe sepsis or septic shock.

  1. Inclusion Criteria:

    1. adult (≥ 18 year) patients;
    2. signed informed consent before surgical procedure;
    3. severe sepsis or septic shock;
    4. at least one of the following conditions: i) post-operative peritonitis, ii) recurrent gastrointestinal perforation, iii) post-operative hepatobiliary and/or pancreatic disorders including necrotizing pancreatitis, iv) post-operative intra-abdominal abscess, and v) anastomotic leak.
  2. Exclusion criteria a. diagnosis of candidiasis before the enrollment b. exposure in the past 30 days to any antifungal treatment or diagnosis of invasive fungal infection; c. pregnancy or lactation; d. history of allergy to any
    Sponsor: University of Bologna

    Current Primary Outcome:

    • Antifungal consumption [ Time Frame: 28 days ]
      Days of antifungal consumption will be compared between the two groups
    • Mortality [ Time Frame: 28 days ]
      28-day mortality will be compared between the two groups
    • Length of stay [ Time Frame: 28 days ]
      Length of stay in ICU will be compared between the two groups


    Original Primary Outcome:

    • Antifungal consumption [ Time Frame: 28 days ]
      Days of antifungal consumption will be compared between the two groups
    • Mortality [ Time Frame: 28 days ]
      28-day mortality will be compared between the two groups
    • Lenght of stay [ Time Frame: 28 days ]
      Lenght of stay in ICU will be compared between the two groups


    Current Secondary Outcome: Accuracy of BG [ Time Frame: 28 days ]

    sensitivity, specificity, positive predictive value, negative predictive value of BG in the diagnosis of invasive candidiasis


    Original Secondary Outcome: Same as current

    Information By: University of Bologna

    Dates:
    Date Received: March 18, 2017
    Date Started: March 1, 2017
    Date Completion: December 2018
    Last Updated: March 30, 2017
    Last Verified: March 2017