Peritoneal 1.3-ß-D-glucan for the Diagnosis of Intra-abdominal Candidiasis in Critically Ill Patients (pBDG2) (pBDG2)

Prospective Evaluation of 1.3-ß-D-glucan in the Peritoneal Fluid for the Diagnosis of Fungal Peritonitis in Critically Ill Patients

New rapid diagnostic strategies are warranted in intra-abdominal candidiasis (IAC). A previous retrospective study showed that one measure, the day of the surgery, of peritoneal 1.3-Beta-D-Glucan ≤ 310pg/ml could rule out an IAC. This strategy was independent of the patient underlying conditions and Candida risk factors. This study aimed to confirm these results with a multicenter prospective study

Study Overview

• Status: Completed
• Conditions: Candidiasis, Invasive; Critically Ill; Intra Abdominal Infections; Peritoneal Candidiasis
• Intervention / Treatment: Diagnostic test: 1.3 BETA D GLUCAN

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• France
  • Besançon, France, 25030
    • PILI-FLOURY Sebastien
  • Dijon, France, 21079
    • BOUHEMAD Belaid
  • Strasbourg, France, 67098
    • POTTECHER Julien
  • Lorraine
    • Metz, Lorraine, France, 57000
      • CHR Mercy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Inclusion of 200 patients. Among them, identification of : 50 Cases (confirmed intra abdominal candidiasis) and 50 controls (intra abdominal infection without candida).

If more than 50 cases, random selection. Identification of control by matching (with confounding factors of the 1.3 BDG test). If more than 50 controls after matching, random selection.

Description

Inclusion Criteria:

• critically ill adult (> 18 yrs old) admitted to ICU for intra-abdominal infection requiring surgery and possible intra abdominal candidiasis

Exclusion Criteria:

• declinate to participate,
• expected death within the first 24 hours

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CASE (intra abdominal candidiasis); Critically ill patients with a confirmed diagnosis of intra abdominal candidiasis (IAC) Definition of IAC : sterilely collected peritoneal fluid cultures that are positive for Candida spp. as determined by the signs and symptoms consistent with an active infection	Diagnostic test: 1.3 BETA D GLUCAN; dosage of 1.3 BETA D GLUCAN in the peritoneal fluid obtained during surgery with the β-glucan test (Fujifilm Wako Chemicals, Osaka, Japan)
CONTROL (bacterial intra abdominal infection); Critically ill patients with a non candida intra abdominal infection (bacterial peritonitis)	Diagnostic test: 1.3 BETA D GLUCAN; dosage of 1.3 BETA D GLUCAN in the peritoneal fluid obtained during surgery with the β-glucan test (Fujifilm Wako Chemicals, Osaka, Japan)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure of 1.3 BDG in the peritoneal exudate of patient with intra-abdominal candidiasis	Value of 1.3 BDG in the peritoneal exudate in patient with intra-abdominal candidiasis in comparison with non intra-abdominal candidiasis	1 DAY

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure of 1.3 BDG in the serum of patient with intra-abdominal candidiasis	Coefficient of correlation between peritoneal and serum 1.3 BDG in patient with and without intra-abdominal candidiasis	DAY 1 and DAY 3

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Principal Investigator: Emmanuel NOVY, MD, Central Hospital, Nancy, France

Publications and helpful links

General Publications

• Novy E, Laithier FX, Machouart MC, Albuisson E, Guerci P, Losser MR. Determination of 1,3-beta-D-glucan in the peritoneal fluid for the diagnosis of intra-abdominal candidiasis in critically ill patients: a pilot study. Minerva Anestesiol. 2018 Dec;84(12):1369-1376. doi: 10.23736/S0375-9393.18.12619-8. Epub 2018 Jul 9.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 20, 2020
• Primary Completion (ACTUAL): December 31, 2022
• Study Completion (ACTUAL): February 7, 2023

Study Registration Dates

• First Submitted: May 9, 2019
• First Submitted That Met QC Criteria: June 24, 2019
• First Posted (ACTUAL): June 25, 2019

Study Record Updates

• Last Update Posted (ESTIMATE): February 9, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Disease Attributes; Bacterial Infections and Mycoses; Mycoses; Invasive Fungal Infections; Candidiasis; Candidiasis, Invasive; Intraabdominal Infections; Critical Illness
• Other Study ID Numbers: 2019PI074

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all IPD that underlie results in a publication
• IPD Sharing Time Frame: Available from inclusion to end of participation of the included patient
• IPD Sharing Access Criteria: Only access to IPD of patient of the own participating ICU Access by code
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes