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

NCT03997929 — Completed, 200 participants, Central Hospital, Nancy, France

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

Registry	NCT03997929, acronym pBDG2
Status	Completed
Study type	Observational
Enrollment	200 (Actual)
Sponsor	Central Hospital, Nancy, France (Other)
Conditions	Intra Abdominal Infections, Candidiasis, Invasive, Peritoneal Candidiasis, Critically Ill
Interventions	1.3 BETA D GLUCAN (Diagnostic test)
Dates	start 2020-01-20, primary completion 2022-12-31, completion 2023-02-07, first posted 2019-06-25, last updated 2023-02-09
Locations	4 sites in France

-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

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+Arms and interventions

Arm	Type	Interventions	Description
CASE (intra abdominal candidiasis)		Diagnostic Test: 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
CONTROL (bacterial intra abdominal infection)		Diagnostic Test: 1.3 BETA D GLUCAN	Critically ill patients with a non candida intra abdominal infection (bacterial peritonitis)

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)

+Outcome measures

Primary outcomes

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 outcomes

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

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (4)

Facility	City	Country
CHR Mercy	Metz, Lorraine	France
PILI-FLOURY Sebastien	Besançon	France
BOUHEMAD Belaid	Dijon	France
POTTECHER Julien	Strasbourg	France

+Publications

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
Results publication: 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

+Investigators

Emmanuel NOVY, MD, Principal investigator, Central Hospital, Nancy, France

My Notes

Public

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