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

NCT03997929 | Completed FDA Device

• 1 other identifier: 2019PI074
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Intra Abdominal Infections; Candidiasis, Invasive; Peritoneal Candidiasis; Critically Ill

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Measure of 1.3 BDG in the serum of patient with intra-abdominal candidiasis

  DAY 1 and DAY 3

Study Arms (2)

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

CONTROL (bacterial intra abdominal infection)

Critically ill patients with a non candida intra abdominal infection (bacterial peritonitis)

Diagnostic Test: 1.3 BETA D GLUCAN

Interventions

1.3 BETA D GLUCAN DIAGNOSTIC_TEST

dosage of 1.3 BETA D GLUCAN in the peritoneal fluid obtained during surgery with the β-glucan test (Fujifilm Wako Chemicals, Osaka, Japan)

CASE (intra abdominal candidiasis); CONTROL (bacterial intra abdominal infection)

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (4)

CHR Mercy

Metz, Lorraine, 57000, France

Location

PILI-FLOURY Sebastien

Besançon, 25030, France

Location

BOUHEMAD Belaid

Dijon, 21079, France

Location

POTTECHER Julien

Strasbourg, 67098, France

Location

Related Publications (2)

• Novy, E.; Laithier, F.-X.; Riviere, J.; Remen, T.; Losser, M.-R.; Guerci, P.; Machouart, M. Protocol for the pBDG2 Study: Prospective Evaluation of 1.3-β-D-Glucan in the Peritoneal Fluid for the Diagnosis of Intra-Abdominal Candidiasis in Critically Ill Patients. Microbiol. Res. 2021, 12, 196-203. https://doi.org/10.3390/microbiolres12010015

  BACKGROUND

• 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.

  PMID: 29991219 RESULT

MeSH Terms

Conditions

Intraabdominal Infections; Candidiasis, Invasive; Critical Illness

Condition Hierarchy (Ancestors)

Infections; Candidiasis; Mycoses; Bacterial Infections and Mycoses; Invasive Fungal Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Emmanuel NOVY, MD

  Central Hospital, Nancy, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2019
• First Posted: June 25, 2019
• Study Start: January 20, 2020
• Primary Completion: December 31, 2022
• Study Completion: February 7, 2023
• Last Updated: February 9, 2023

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Available from inclusion to end of participation of the included patient
• Access Criteria: Only access to IPD of patient of the own participating ICU Access by code

Locations

FR (4)