Evaluation of BD Glucan in Peritoneal Fluid for the Diagnosis of Fungal Peritonitis

Completed

• Conditions: Adult Patient (Over 18 Yr-old) Admitted to the ICU for Acute Peritonitis
• Interventions: Other: Intervention

• Registration Number: NCT03469401
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

Invasive candidiasis has a high mortality rate, around 40%. Outcome remains tightly linked to the time of treatment administration. Routine microbiological techniques give results too lately to allow prompt antifungal therapy initiation (at least 48 hours). It is important to develop diagnostic tools to initiate antifungal therapy as early as possible.

The B D glucan detection, one of the major components of the candida cell wall, can be useful for a early diagnosis.

There are several techniques on the market for the detection of glucan. In Europe and America, the most used is Fungitell (Associated of Cape Cod, Inc).

There is several studies about the use of such kits for fungemia. A number of studies are reporting evidences of a early diagnosis.

But, in medical literature, there isn't study focused on the detection of B D glucan in peritoneal fluid for Candida peritonitis diagnosis.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-18
• Study First Submitted: 2018-03-12
• Study First Submitted QC: 2018-03-12
• Study First Posted: 2018-03-19
• Primary Completion: 2019-01-18
• Study Completion: 2019-02-18
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-12
• Last Update Posted: 2019-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

Inclusion Criteria

• Aged ≥ 18 years old
• written informed consent for inclusion in the study
• stay in intensive care unit
• diagnosed with a peritonitis
• peritoneal fluid collected by a surgery or radiology procedure, analysed at bacteriology laboratory of l'institut des agents infectieux, l'hôpital de la Croix Rousse

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Exclusion Criteria

• Pregnant woman
• Moribund patient

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
intervention	Intervention	Adult patient (over 18 yr-old) admitted to the ICU for acute peritonitis with a peritoneal fl:uid sample obtained via surgery or radiological drainage

Primary Outcome Measures

Name	Time	Method
Evaluation of sensibility, specificity, negative and positive predictive value of BD glucan in peritoneal fluid for diagnosis of fungal peritonitis, compared with fungal culture	1 year	Evaluation of sensibility, specificity, negative and positive predictive value of BD glucan in peritoneal fluid for diagnosis of fungal peritonitis, compared with fungal culture

Trial Locations

Locations (1)

Centre Hospitalier Lyon Sud; 🇫🇷 Pierre-Bénite, France