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

NCT ID: NCT03997929

Last Updated: 2023-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-20

Study Completion Date

2023-02-07

Brief Summary

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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

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Conditions

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Intra Abdominal Infections Candidiasis, Invasive Peritoneal Candidiasis Critically Ill

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

1.3 BETA D GLUCAN

Intervention Type 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)

CONTROL (bacterial intra abdominal infection)

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

1.3 BETA D GLUCAN

Intervention Type 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)

Interventions

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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)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emmanuel NOVY, MD

Role: PRINCIPAL_INVESTIGATOR

Central Hospital, Nancy, France

Locations

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CHR Mercy

Metz, Lorraine, France

Site Status

PILI-FLOURY Sebastien

Besançon, , France

Site Status

BOUHEMAD Belaid

Dijon, , France

Site Status

POTTECHER Julien

Strasbourg, , France

Site Status

Countries

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France

References

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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

Reference Type 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.

Reference Type RESULT
PMID: 29991219 (View on PubMed)

Other Identifiers

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2019PI074

Identifier Type: -

Identifier Source: org_study_id

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