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

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ClinicalTrials.gov Identifier: NCT03997929
Recruitment Status : Recruiting
First Posted : June 25, 2019
Last Update Posted : February 24, 2020
Sponsor:
Information provided by (Responsible Party):
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

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

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Days
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 : January 20, 2020
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : September 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Yeast Infections

Group/Cohort 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)




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Inclusion of 200 patients. Among them, identification of : 50 Cases (confirmed intra abdominal candidiasis) and 50 controls (intra abdominal infection without candida).

If more than 50 cases, random selection. Identification of control by matching (with confounding factors of the 1.3 BDG test). If more than 50 controls after matching, random selection.

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03997929


Contacts
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Contact: Emmanuel NOVY, MD +33383157437 e.novy@chru-nancy.fr
Contact: El Mehdi SIAGHY +3383155276 m.siaghy@chru-nancy.fr

Locations
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France
CHR Mercy Recruiting
Metz, Lorraine, France, 57000
Contact: Guillaume LOUIS, MD    00 33 387186214    g.louis@chr-metz-thionville.fr   
PILI-FLOURY Sebastien Recruiting
Besançon, France, 25030
BOUHEMAD Belaid Recruiting
Dijon, France, 21079
POTTECHER Julien Recruiting
Strasbourg, France, 67098
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
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Principal Investigator: Emmanuel NOVY, MD Central Hospital, Nancy, France
Publications:
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Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT03997929    
Other Study ID Numbers: 2019PI074
First Posted: June 25, 2019    Key Record Dates
Last Update Posted: February 24, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: all IPD that underlie results in a publication
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Available from inclusion to end of participation of the included patient
Access Criteria: Only access to IPD of patient of the own participating ICU Access by code

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Candidiasis
Intraabdominal Infections
Candidiasis, Invasive
Critical Illness
Disease Attributes
Pathologic Processes
Mycoses
Infection
Invasive Fungal Infections