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

Sponsor

Central Hospital, Nancy, France (Other)

Overall Status

Unknown status

CT.gov ID

NCT03997929

Collaborator

(none)

200

Enrollment

Locations

19.4

Anticipated Duration (Months)

Patients Per Site

2.6

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Intra Abdominal Infections Candidiasis, Invasive Peritoneal Candidiasis Critically Ill	Diagnostic Test: 1.3 BETA D GLUCAN

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 20, 2020

Anticipated Primary Completion Date :

Sep 1, 2020

Anticipated Study Completion Date :

Sep 1, 2021

Arms and Interventions

Arm	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 FUNGITELL test (Associate of CAPE COD)
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 FUNGITELL test (Associate of CAPE COD)

Arm

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 FUNGITELL test (Associate of CAPE COD)

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 FUNGITELL test (Associate of CAPE COD)

Outcome Measures

Primary Outcome Measures

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

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 Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHR Mercy	Metz	Lorraine	France	57000
2	PILI-FLOURY Sebastien	Besançon		France	25030
3	BOUHEMAD Belaid	Dijon		France	21079
4	POTTECHER Julien	Strasbourg		France	67098

Sponsors and Collaborators

Central Hospital, Nancy, France

Investigators

Principal Investigator: Emmanuel NOVY, MD, Central Hospital, Nancy, France

Study Documents (Full-Text)

None provided.

More Information

Publications

Novy E, Laithier FX, Machouart MC, Albuisson E, Guerci P, Losser MR. Determination of 1,3-β-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.

Responsible Party:

Central Hospital, Nancy, France

ClinicalTrials.gov Identifier:

NCT03997929

Other Study ID Numbers:

2019PI074

First Posted:

Jun 25, 2019

Last Update Posted:

Feb 24, 2020

Last Verified:

Feb 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Candidiasis

Intraabdominal Infections

Candidiasis, Invasive

Critical Illness

Study Results

No Results Posted as of Feb 24, 2020