NCT03469401

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 18, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 12, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 19, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 18, 2019

Completed
Last Updated

September 4, 2025

Status Verified

August 1, 2025

Enrollment Period

1 year

First QC Date

March 12, 2018

Last Update Submit

August 27, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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

Interventions

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

intervention

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Aged ≥ 18 years old
  • 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

You may not qualify if:

  • Pregnant woman
  • Moribund patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Lyon Sud

Pierre-Bénite, France

Location

Related Publications (1)

  • Nourry E, Wallet F, Darien M, Menotti J, Dupont D, Allaouchiche B, Argaud L, Richard JC, Guichon C, Rimmele T, Bohe J, Thiollere F, Vassal O, Lepape A, Wallon M, Persat F, Friggeri A. Use of 1,3-Beta-D-Glucan concentration in peritoneal fluid for the diagnosis of intra-abdominal Candidiasis in Critically-ill patients. Med Mycol. 2023 Mar 20:myad029. doi: 10.1093/mmy/myad029. Online ahead of print.

    PMID: 36941133BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

peritoneal fluid

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Florent WALLET, MD

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2018

First Posted

March 19, 2018

Study Start

January 18, 2018

Primary Completion

January 18, 2019

Study Completion

February 18, 2019

Last Updated

September 4, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations