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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03090334
Recruitment Status : Recruiting
First Posted : March 24, 2017
Last Update Posted : April 18, 2019
Information provided by (Responsible Party):
Maddalena Giannella, University of Bologna

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.

Condition or disease Intervention/treatment Phase
Invasive Candidiases Abdominal Infection Diagnostic Test: De-escalation Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Masking Description: Care provider will be blinded to result of BG in patients enrolled in the standard of care arm
Primary Purpose: Other
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
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Yeast Infections

Arm Intervention/treatment
Experimental: De-escalation

In this group, investigators will manage the antifungal therapy according to the BG levels as follows:

  1. antifungal therapy will be stopped immediately after the BG response in case of serum BG <80 pg/ml in presence of clinical stability (CS);
  2. antifungal therapy will be continued until further BG determination, both for BG levels between 80-200 pg/ml and for BG <80 pg/ml in patients without CS. In these cases, if the following BG value is <80 pg/ml antifungal therapy will be stopped independently from the CS achievement.
  3. antifungal therapy will be continued until day 10 for BG levels >200 pg/ml
Diagnostic Test: De-escalation
Antifungal therapy will be stopped according with BG results

No Intervention: Standard of care

In this group antifungal treatment will be continued until clinician's decision.

Investigators will be blinded to the BG levels of patients enrolled in this arm, The BG results will be faxed directly to the coordinating center.

Primary Outcome Measures :
  1. Antifungal consumption [ Time Frame: 28 days ]
    Days of antifungal consumption will be compared between the two groups

  2. Mortality [ Time Frame: 28 days ]
    28-day mortality will be compared between the two groups

  3. Length of stay [ Time Frame: 28 days ]
    Length of stay in ICU will be compared between the two groups

Secondary Outcome Measures :
  1. Accuracy of BG [ Time Frame: 28 days ]
    sensitivity, specificity, positive predictive value, negative predictive value of BG in the diagnosis of invasive candidiasis

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • a. adult (≥ 18 year) patients; b. signed informed consent before surgical procedure; c. severe sepsis or septic shock; d. 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.

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 of the antifungal drugs; e. major immunosuppression conditions including: i. neutropenia (<0.5 × 109 neutrophils/L [<500 neutrophils/mm3] for >10 days), ii. receipt of an allogeneic stem cell transplant or solid organ transplantation, iii. inherited severe immunodeficiency (such as chronic granulomatous disease or severe combined immunodeficiency), iv. HIV infection with lymphocyte T CD4+ cell count < 200/mmc. f. patients with poor prognosis or unable to sign informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03090334

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Contact: Maddalena Giannella, MD, phD +39 0512143199
Contact: Michele Bartoletti, MD +39 0512143199

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Azienda Ospealiero Universitaria di Bologna Policlinico S.Orsola-Malpighi Recruiting
Bologna, Italy, 40138
Contact: Maddalena Giannella, MD, PhD    +39 051 2143199   
Sponsors and Collaborators
University of Bologna

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Responsible Party: Maddalena Giannella, MD, University of Bologna Identifier: NCT03090334     History of Changes
Other Study ID Numbers: BDG-ETHIC
First Posted: March 24, 2017    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Maddalena Giannella, University of Bologna:
abdominal candidiasis
Additional relevant MeSH terms:
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Intraabdominal Infections
Candidiasis, Invasive
Invasive Fungal Infections
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP3A Inhibitors