Intra Abdominal InfectionspBDG2NCT03997929
Peritoneal 1.3-ß-D-glucan for the Diagnosis of Intra-abdominal Candidiasis in Critically Ill Patients (pBDG2)
An observational study of Intra Abdominal Infections and Candidiasis, Invasive, run by Central Hospital, Nancy, France at 4 sites in France.
Trial summary
New rapid diagnostic strategies are warranted in intra-abdominal candidiasis (IAC). A previous retrospective study showed that one measure, the day of the surgery, of peritoneal 1.3-Beta-D-Glucan ≤ 310pg/ml could rule out an IAC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intra Abdominal Infections, Candidiasis, Invasive, Peritoneal Candidiasis
- What is being tested?
- 1.3 BETA D GLUCAN
- How many people
- 200 participants
- Where
- 4 sitesFrance
- Study dates
- 20 Jan 2020to 7 Feb 2023
- How long will I take part?
- 10 Days
- 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: Inclusion of 200 patients. Among them, identification of : 50 Cases (confirmed intra abdominal candidiasis) and 50 controls (intra abdominal infection without candida). If more than 50 cases, random selection. Identification of control by matching (with confounding factors of the 1.3 BDG test). If more than 50 controls after matching, random selection.
Who may be able to join
- critically ill adult (> 18 yrs old) admitted to ICU for intra-abdominal infection requiring surgery and possible intra abdominal candidiasis
Who cannot join
- declinate to participate,
- expected death within the first 24 hours
Trial locations and contacts
4 sites in 1 country.
France4 sites
PILI-FLOURY Sebastien
Besançon, 25030
BOUHEMAD Belaid
Dijon, 21079
CHR Mercy
Metz, Lorraine, 57000
POTTECHER Julien
Strasbourg, 67098
About this study
Official title: Prospective Evaluation of 1.3-ß-D-glucan in the Peritoneal Fluid for the Diagnosis of Fungal Peritonitis in Critically Ill Patients
New rapid diagnostic strategies are warranted in intra-abdominal candidiasis (IAC). A previous retrospective study showed that one measure, the day of the surgery, of peritoneal 1.3-Beta-D-Glucan ≤ 310pg/ml could rule out an IAC. This strategy was independent of the patient underlying conditions and Candida risk factors. This study aimed to confirm these results with a multicenter prospective study
- Being tested
- 1.3 BETA D GLUCAN
- Medical subject headings
- Intraabdominal Infections, Candidiasis, Invasive, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1.3 BETA D GLUCANDiagnostic test
dosage of 1.3 BETA D GLUCAN in the peritoneal fluid obtained during surgery with the β-glucan test (Fujifilm Wako Chemicals, Osaka, Japan)
| Study group | Role | What they receive |
|---|---|---|
| CASE (intra abdominal candidiasis) | Critically ill patients with a confirmed diagnosis of intra abdominal candidiasis (IAC) Definition of IAC : sterilely collected peritoneal fluid cultures that are positive for Candida spp. as determined by the signs and symptoms consistent with an active infection Receives: Diagnostic Test: 1.3 BETA D GLUCAN | |
| CONTROL (bacterial intra abdominal infection) | Critically ill patients with a non candida intra abdominal infection (bacterial peritonitis) Receives: Diagnostic Test: 1.3 BETA D GLUCAN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of 1.3 BDG in the peritoneal exudate of patient with intra-abdominal candidiasis
Value of 1.3 BDG in the peritoneal exudate in patient with intra-abdominal candidiasis in comparison with non intra-abdominal candidiasis
Measured: 1 DAY
Secondary outcomes (1)
Measure of 1.3 BDG in the serum of patient with intra-abdominal candidiasis
Coefficient of correlation between peritoneal and serum 1.3 BDG in patient with and without intra-abdominal candidiasis
Measured: DAY 1 and DAY 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2019
- Study start20 Jan 2020
- Primary completion31 Dec 2022
- Study completion7 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intra Abdominal InfectionsStudies 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
- Prospective
- Enrolment
- 200 participants (actual)
- Target duration
- 10 Days
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuel NOVY, MD, Principal investigator, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03997929
- Sponsor's protocol ID
- 2019PI074
- Acronym
- pBDG2
- Status last verified
- Feb 2022
- First submitted
- 9 May 2019
- Last updated
- 9 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Publications
Novy, E.; Laithier, F.-X.; Riviere, J.; Remen, T.; Losser, M.-R.; Guerci, P.; Machouart, M. Protocol for the pBDG2 Study: Prospective Evaluation of 1.3-β-D-Glucan in the Peritoneal Fluid for the Diagnosis of Intra-Abdominal Candidiasis in Critically Ill Patients. Microbiol. Res. 2021, 12, 196-203. https://doi.org/10.3390/microbiolres12010015
Novy E, Laithier FX, Machouart MC, Albuisson E, Guerci P, Losser MR. Determination of 1,3-beta-D-glucan in the peritoneal fluid for the diagnosis of intra-abdominal candidiasis in critically ill patients: a pilot study. Minerva Anestesiol. 2018 Dec;84(12):1369-1376. doi: 10.23736/S0375-9393.18.12619-8. Epub 2018 Jul 9.
PubMed 29991219
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of 1.3-ß-D-glucan in the Peritoneal Fluid for the Diagnosis of Fungal Peritonitis in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT03997929
- Acronym / sponsor ID
- pBDG2 / 2019PI074
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 7 Feb 2023 (actual)
- First posted
- 25 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.
New rapid diagnostic strategies are warranted in intra-abdominal candidiasis (IAC). A previous retrospective study showed that one measure, the day of the surgery, of peritoneal 1.3-Beta-D-Glucan ≤ 310pg/ml could rule out an IAC. This strategy was independent of the patient underlying conditions and Candida risk factors. This study aimed to confirm these results with a multicenter prospective study
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CASE (intra abdominal candidiasis) | – | Diagnostic Test: 1.3 BETA D GLUCANCritically ill patients with a confirmed diagnosis of intra abdominal candidiasis (IAC) Definition of IAC : sterilely collected peritoneal fluid cultures that are positive for Candida spp. as determined by the signs and symptoms consistent with an active infection |
| CONTROL (bacterial intra abdominal infection) | – | Diagnostic Test: 1.3 BETA D GLUCANCritically ill patients with a non candida intra abdominal infection (bacterial peritonitis) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inclusion of 200 patients. Among them, identification of : 50 Cases (confirmed intra abdominal candidiasis) and 50 controls (intra abdominal infection without candida). If more than 50 cases, random selection. Identification of control by matching (with confounding factors of the 1.3 BDG test). If more than 50 controls after matching, random selection.
Key inclusion criteria (1 listed)
- critically ill adult (> 18 yrs old) admitted to ICU for intra-abdominal infection requiring surgery and possible intra abdominal candidiasis
Key exclusion criteria (2 listed)
- declinate to participate,
- expected death within the first 24 hours
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 |
|---|---|---|
| 1.3 BETA D GLUCANdosage of 1.3 BETA D GLUCAN in the peritoneal fluid obtained during surgery with the β-glucan test (Fujifilm Wako Chemicals, Osaka, Japan) | Diagnostic test | CASE (intra abdominal candidiasis), CONTROL (bacterial intra abdominal infection) |
Primary outcome
Measure of 1.3 BDG in the peritoneal exudate of patient with intra-abdominal candidiasis
Time frame: 1 DAY
Value of 1.3 BDG in the peritoneal exudate in patient with intra-abdominal candidiasis in comparison with non intra-abdominal candidiasis
1 secondary outcome
Measure of 1.3 BDG in the serum of patient with intra-abdominal candidiasis
Time frame: DAY 1 and DAY 3
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 9 Feb 2023.
- BackgroundNovy, E.; Laithier, F.-X.; Riviere, J.; Remen, T.; Losser, M.-R.; Guerci, P.; Machouart, M. Protocol for the pBDG2 Study: Prospective Evaluation of 1.3-β-D-Glucan in the Peritoneal Fluid for the Diagnosis of Intra-Abdominal Candidiasis in Critically Ill Patients. Microbiol. Res. 2021, 12, 196-203. https://doi.org/10.3390/microbiolres12010015
- Results publication: PubMed 29991219Novy E, Laithier FX, Machouart MC, Albuisson E, Guerci P, Losser MR. Determination of 1,3-beta-D-glucan in the peritoneal fluid for the diagnosis of intra-abdominal candidiasis in critically ill patients: a pilot study. Minerva Anestesiol. 2018 Dec;84(12):1369-1376. doi: 10.23736/S0375-9393.18.12619-8. Epub 2018 Jul 9.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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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.
Emmanuel NOVY, MD principal investigator
Central Hospital, Nancy, France
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intra Abdominal Infections and Candidiasis, Invasive, run by Central Hospital, Nancy, France at 4 sites 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 2 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 9 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Measure of 1.3 BDG in the peritoneal exudate of patient with intra-abdominal candidiasis (time frame: 1 DAY). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03997929, which also lists 2 linked publications.
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 9 Feb 2023.