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PeritonitisPERISCORENCT03973645

Performance of Clinical and Biological Diagnostic Tests in Reference to the Recommended Tests for the Management of Fungal Peritonitis in Intensive Care

An observational study of Peritonitis, run by Central Hospital, Nancy, France at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Fungal peritonitis accounts for nearly 70% of invasive candidiasis in surgical resuscitation. Their mortality is high, around 38% and their morbidity also with an increase in length of stay in intensive care, invasive ventilation times and an increase in the number of surgical revisions. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Peritonitis
What is being tested?
Patient presenting peritonitis managed with fungal research during year 2016
How many people
33 participants
Where
1 siteFrance
Study dates
1 Mar 2017to 30 Sep 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patient> 18 years old who has been treated for peritonitis in intensive care unit in CHRU de Nancy during year 2016

Who may be able to join

  • Any patient> 18 years old who has been treated for peritonitis in intensive care unit in CHRU de Nancy during year 2016

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

France1 site
  • CHRU De Nancy

    Vandœuvre-lès-Nancy, 54500

Other trials in France

About this study

Fungal peritonitis accounts for nearly 70% of invasive candidiasis in surgical resuscitation. Their mortality is high, around 38% and their morbidity also with an increase in length of stay in intensive care, invasive ventilation times and an increase in the number of surgical revisions.

Currently, diagnostic and therapeutic management is based on clinical prognostic scores, of which the "Peritonitis score" (PS) is still used as a reference. These scores are intended to best target a population eligible for probabilistic antifungal treatment pending the confirmation or not of the fungal characteristic of peritonitis by the fungal culture (Gold Standard). In case of severe peritonitis, if the PS is> or = to 3, the clinician must start a broad-spectrum antifungal treatment which will be continued if the culture of the peritoneal fluid is positive to yeast. If it is <3, it is not recommended to introduce an anti-fungal outside of very particular cases. In this situation, an anti-fungal treatment is only started if the direct examination of the peritoneal liquid made within 24 hours is positive to yeast or, failing this, to the reception of a positive culture several days later.

Read more

However, recent reviews of the "Peritonitis score" have emerged from the analysis of the "fungal peritonitis" subgroup of the AmarCand II study (underestimation in particular) , highlighting the difficulty of identifying this target population. In addition, none of these clinical scores have demonstrated superiority in guiding probabilistic antifungal therapy. Direct examination of peritoneal fluid also suffers from low sensitivity.

New diagnostic approaches using, among other things, blood markers (panfungal PCR, 1,3-Beta-D-glucan, etc.) have developed in recent years. In particular, 1,3-Beta-D-glucan has demonstrated superiority to the candida score in the early diagnosis of intra-abdominal candidiasis. [8]. His main interest lies in his strong Negative predictive value. The association of these markers is another way of working to improve their diagnostic performance. The use of these blood markers is encouraged by European and international consensus, however, their dosage in the peritoneal fluid is still under study.

One of the consequences of these diagnostic difficulties is the occurrence of inadequate prescriptions of antifungals in more than 40% of cases of fungal peritonitis in intensive care, or even more than 70% of cases in the case of any type of candidiasis. invasive.

The investigators therefore seek to study the diagnostic performance of fungal markers (BDG and PCR) increasingly realized in CHRU de Nancy in reference to the recommended tests (clinical (PS) and microbiological (ED and culture))

Conditions
Peritonitis
Being tested
Patient presenting peritonitis managed with fungal research during year 2016
Medical subject headings
Peritonitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Patient presenting peritonitis managed with fungal research during year 2016Other

    Patient presenting a peritoneal fungal with panfungal PCR and BDG compared to Peritonitis score (PS) and microbiological (ED direct fungal examination)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Positivity or negativity of each of the different markers studied for the calculation of Sensitivity / Specificity and Positive predictive value / VPN by taking the fungal culture of peritoneal fluid as gold standard.

    Measured: Day 1- the day of surgery- at inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2019
  2. Study start1 Mar 2017
  3. Primary completion30 Sep 2017
  4. Study completion30 Sep 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03973645
Sponsor's protocol ID
PSS2017/PERISCORE-NOVY/ELR
Acronym
PERISCORE
Status last verified
Jun 2019
First submitted
28 May 2019
Last updated
4 Jun 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Peritonitis, run by Central Hospital, Nancy, France at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Positivity or negativity of each of the different markers studied for the calculation of Sensitivity / Specificity and Positive predictive value / VPN by taking the fungal culture of peritoneal fluid as gold standard. (time frame: Day 1- the day of surgery- at inclusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2019.

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