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

NCT03090334 | Terminated

• 1 other identifier: BDG-ETHIC
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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. 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. 2.continue antifungal treatment according with attending physician's decision.

Conditions

Invasive Candidiases; Abdominal Infection

Keywords

beta-d-glucan; abdominal candidiasis

Outcome Measures

Primary Outcomes (3)

• Antifungal consumption

  Days of antifungal consumption will be compared between the two groups

  28 days

• Mortality

  28-day mortality will be compared between the two groups

  28 days

• Length of stay

  Length of stay in ICU will be compared between the two groups

  28 days

Secondary Outcomes (1)

• Accuracy of BG

  28 days

Study Arms (2)

De-escalation

EXPERIMENTAL

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

Standard of care

NO INTERVENTION

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.

Interventions

De-escalation DIAGNOSTIC_TEST

Antifungal therapy will be stopped according with BG results

De-escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Bologna: lead

Study Sites (1)

Azienda Ospealiero Universitaria di Bologna Policlinico S.Orsola-Malpighi

Bologna, 40138, Italy

Location

Related Publications (4)

• Bassetti M, Marchetti M, Chakrabarti A, Colizza S, Garnacho-Montero J, Kett DH, Munoz P, Cristini F, Andoniadou A, Viale P, Rocca GD, Roilides E, Sganga G, Walsh TJ, Tascini C, Tumbarello M, Menichetti F, Righi E, Eckmann C, Viscoli C, Shorr AF, Leroy O, Petrikos G, De Rosa FG. A research agenda on the management of intra-abdominal candidiasis: results from a consensus of multinational experts. Intensive Care Med. 2013 Dec;39(12):2092-106. doi: 10.1007/s00134-013-3109-3. Epub 2013 Oct 9.

  PMID: 24105327 BACKGROUND

• Kollef M, Micek S, Hampton N, Doherty JA, Kumar A. Septic shock attributed to Candida infection: importance of empiric therapy and source control. Clin Infect Dis. 2012 Jun;54(12):1739-46. doi: 10.1093/cid/cis305. Epub 2012 Mar 15.

  PMID: 22423135 BACKGROUND

• Maubon D, Garnaud C, Calandra T, Sanglard D, Cornet M. Resistance of Candida spp. to antifungal drugs in the ICU: where are we now? Intensive Care Med. 2014 Sep;40(9):1241-55. doi: 10.1007/s00134-014-3404-7. Epub 2014 Aug 5.

  PMID: 25091787 BACKGROUND

• Clancy CJ, Nguyen MH. Finding the "missing 50%" of invasive candidiasis: how nonculture diagnostics will improve understanding of disease spectrum and transform patient care. Clin Infect Dis. 2013 May;56(9):1284-92. doi: 10.1093/cid/cit006. Epub 2013 Jan 11.

  PMID: 23315320 BACKGROUND

MeSH Terms

Conditions

Candidiasis, Invasive; Intraabdominal Infections

Condition Hierarchy (Ancestors)

Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Invasive Fungal Infections

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Care provider will be blinded to result of BG in patients enrolled in the standard of care arm
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 18, 2017
• First Posted: March 24, 2017
• Study Start: March 1, 2017
• Primary Completion: June 10, 2019
• Study Completion: June 10, 2019
• Last Updated: August 28, 2024

Record last verified: 2024-08

Locations

IT (1)