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.
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.
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.
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.
- First posted4 Jun 2019
- Study start1 Mar 2017
- Primary completion30 Sep 2017
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeritonitisStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of Clinical and Biological Diagnostic Tests in Reference to the Recommended Tests for the Management of Fungal Peritonitis in Intensive Care
- ClinicalTrials.gov ID
- NCT03973645
- Acronym / sponsor ID
- PERISCORE / PSS2017/PERISCORE-NOVY/ELR
- Conditions
- Peritonitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 4 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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))
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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
Key inclusion criteria (1 listed)
- Any patient> 18 years old who has been treated for peritonitis in intensive care unit in CHRU de Nancy during year 2016
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient presenting peritonitis managed with fungal research during year 2016Patient presenting a peritoneal fungal with panfungal PCR and BDG compared to Peritonitis score (PS) and microbiological (ED direct fungal examination) | Other | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.