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

August 12, 2019 updated by: Hospices Civils de Lyon

Evaluation of the Detection of B D Glucan in Peritonitis Fluid in Intensive Care Unit (ICU) Patients With Peritonitis for the Diagnosis of Fungal Peritonitis, Compared to Routine Microbiology Diagnosis Method. The PERICAND Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

126

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Pierre-Bénite, France
        • Centre Hospitalier Lyon Sud

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patient (over 18 yr-old) admitted to the ICU for acute peritonitis

Description

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

Exclusion Criteria:

  • Pregnant woman
  • Moribund patient

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Other: Intervention
Evaluation of sensibility, specificity, negative and positive predictive value of BD glucan in peritoneal fluid for diagnosis of fungal peritonitis, compared with fungal culture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of sensibility, specificity, negative and positive predictive value of BD glucan in peritoneal fluid for diagnosis of fungal peritonitis, compared with fungal culture
Time Frame: 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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Florent WALLET, MD, Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2018

Primary Completion (Actual)

January 18, 2019

Study Completion (Actual)

February 18, 2019

Study Registration Dates

First Submitted

March 12, 2018

First Submitted That Met QC Criteria

March 12, 2018

First Posted (Actual)

March 19, 2018

Study Record Updates

Last Update Posted (Actual)

August 13, 2019

Last Update Submitted That Met QC Criteria

August 12, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL17_0775

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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