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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03469401
Other study ID # 69HCL17_0775
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 18, 2018
Est. completion date February 18, 2019

Study information

Verified date August 2019
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 126
Est. completion date February 18, 2019
Est. primary completion date January 18, 2019
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms

  • Adult Patient (Over 18 Yr-old) Admitted to the ICU for Acute Peritonitis
  • Peritonitis

Intervention

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

Locations

Country Name City State
France Centre Hospitalier Lyon Sud Pierre-Bénite

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluation of sensibility, specificity, negative and positive predictive value of BD glucan in peritoneal fluid for diagnosis of fungal peritonitis, compared with fungal culture 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