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NCT03997929 Clinical Trial

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

Critically Ill Clinical Trial

— pBDG2  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03997929
Other study ID # 2019PI074
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 20, 2020
Est. completion date February 7, 2023

Study information
Verified date February 2022
Source Central Hospital, Nancy, France
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date February 7, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• 1.3 BETA D GLUCAN
dosage of 1.3 BETA D GLUCAN in the peritoneal fluid obtained during surgery with the ß-glucan test (Fujifilm Wako Chemicals, Osaka, Japan)

Locations
Country Name City State
France PILI-FLOURY Sebastien Besançon
France BOUHEMAD Belaid Dijon
France CHR Mercy Metz Lorraine
France POTTECHER Julien Strasbourg

Sponsors (1)
Lead Sponsor Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Measure of 1.3 BDG in the peritoneal exudate of patient with intra-abdominal candidiasis Value of 1.3 BDG in the peritoneal exudate in patient with intra-abdominal candidiasis in comparison with non intra-abdominal candidiasis 1 DAY
Secondary Measure of 1.3 BDG in the serum of patient with intra-abdominal candidiasis Coefficient of correlation between peritoneal and serum 1.3 BDG in patient with and without intra-abdominal candidiasis DAY 1 and DAY 3
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