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

Completed

• Conditions: Candidiasis, Invasive; Peritoneal Candidiasis; Critically Ill; Intra Abdominal Infections
• Interventions: Diagnostic Test: 1.3 BETA D GLUCAN

• Registration Number: NCT03997929
• Lead Sponsor: Central Hospital, Nancy, France

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-09
• Study First Submitted QC: 2019-06-24
• Study First Posted: 2019-06-25
• Study Start: 2020-01-20
• Status Verified: 2022-02
• Primary Completion: 2022-12-31
• Study Completion: 2023-02-07
• Last Update Submitted: 2023-02-07
• Last Update Posted: 2023-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CONTROL (bacterial intra abdominal infection)	1.3 BETA D GLUCAN	Critically ill patients with a non candida intra abdominal infection (bacterial peritonitis)
CASE (intra abdominal candidiasis)	1.3 BETA D GLUCAN	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

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (4)

PILI-FLOURY Sebastien; 🇫🇷 Besançon, France

POTTECHER Julien; 🇫🇷 Strasbourg, France

BOUHEMAD Belaid; 🇫🇷 Dijon, France

CHR Mercy; 🇫🇷 Metz, Lorraine, France