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Completed

NCT Number: NCT03997929

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

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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Key information

Conditions

Intra Abdominal Infections Bacterial Infections and Mycoses Candidiasis Candidiasis, Invasive Critical Illness Critically Ill Disease Attributes Infections Intraabdominal Infections Invasive Fungal Infections Mycoses Pathologic Processes Pathological Conditions, Signs and Symptoms Peritoneal Candidiasis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHR Mercy, Metz, Lorraine, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Primary outcomes

  1. Measure of 1.3 BDG in the peritoneal exudate of patient with intra-abdominal candidiasis

    Time frame: 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

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

    Time frame: DAY 1 and DAY 3

    Coefficient of correlation between peritoneal and serum 1.3 BDG in patient with and without intra-abdominal candidiasis

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

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

Acronym: pBDG2

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Jun 25, 2019
Registry last updated
Feb 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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