Intra-Abdominal InfectionCANDIDIAGNCT07005258
Diagnostic Performance of the CandID PLUS PCR for the Diagnosis of Intra-abdominal Candidiasis in Critically Ill Patients
An observational study of Intra-Abdominal Infection and Candida, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Invasive candidiasis are the most common form of fungal infection in critically ill patients, particularly intra-abdominal candidiasis (IAC), which is associated with high morbidity and mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intra-Abdominal Infection, Candida, Peritonitis Infectious
- How many people
- 88 participants
- Where
- 1 siteFrance
- Study dates
- 17 Apr 2025to 17 Apr 2025
- 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: The pBDG2 study enrolled 199 ICU patients across four participating centers. Inclusion criteria were: adult ICU patients with suspected intra-abdominal infection likely due to Candida spp., requiring emergency abdominal surgery. Among the enrolled patients, 88 were diagnosed with confirmed intra-abdominal candidiasis based on positive fungal culture. Only these 88 patients will be eligible for inclusion in the CANDIDIAG study. This constitutes a post-hoc analysis of a predefined subpopulation from the pBDG2 cohort. Participating centers included the University Hospitals of Nancy, Dijon, Strasbourg, and the Regional Hospital Center of Metz (CHR Metz)
Who may be able to join
- adult critically ill patient
- with confirmed intra-abdominal candidiasis (culture positive with Candida albicans, glabrata, parapsilosis, tropicalis, krusei, and dubliniensis)
- enrolled in the pBDG2 study (NCT 03997929)
- intra-abdominal candidiasis documented at
Who cannot join
- Declined to participate
- intra-abdominal candidiasis caused by other candida species
Trial locations and contacts
1 site in 1 country.
France1 site
Université de Lorraine - CHRU de Nancy
Vandœuvre-lès-Nancy, Lorraine, 54500
About this study
Official title: Evaluation of the Diagnostic Performance of the CandID PLUS PCR for the Detection of Candida Spp. in Peritoneal Fluid of Critically Ill Patients With Suspected Intra-abdominal Candidiasis
Invasive candidiasis are the most common form of fungal infection in critically ill patients, particularly intra-abdominal candidiasis (IAC), which is associated with high morbidity and mortality. The current diagnostic gold standard relies on conventional fungal culture, which has a long turnaround time and may delay targeted antifungal therapy. Non-culture-based assays such as 1,3-β-D-glucan lack specificity for early and definitive diagnosis. Molecular diagnostics, including PCR, offer faster and more specific detection, but their clinical use remains limited.
The CandID PLUS PCR assay targets major Candida species and has not yet been evaluated on peritoneal fluid.
Read more
The CANDIDIAG study aims to assess the feasibility and diagnostic performance of the CandID PLUS PCR in detecting Candida spp. in peritoneal fluid from ICU patients with suspected IAC.
This study constitutes a post-hoc analysis of the pBDG2 study (Prospective evaluation of the peritoneal 1.3 Beta-D-glucan for the diagnosis of intra-abdominal candidiasis in the critically ill patients) registered with the number NCT 03997929). Therefore, all patients have been already recruited. For the CANDIDIAG study, we will use the biological collection of peritoneal fluid issue from the pBDG2 study. All patients with confirmed intra-abdominal candidiasis are identified. We will test de CandID PCR, retrospectively, on their peritoneal fluid and compared the results with the fungal culture.
- Conditions
- Intra-Abdominal Infection, Candida, Peritonitis Infectious, Molecular Diagnostic, Critically Ill Intensive Care Unit Patients
- Keywords
- intra-abdominal candidiasis, secondary peritonitis, candida, PCR, molecular diagnostic
- Medical subject headings
- Intraabdominal Infections, Torulopsis, Peritonitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Critically ill patients with intra-abdominal candidiasis requiring abdominal surgery | All patients have confirmed intra-abdominal candidiasis (positive Candida culture) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the diagnostic performance of the CandID PLUS PCR for the detection of Candida albicans, glabrata, parapsilosis, tropicalis, krusei, and dubliniensis in peritoneal fluid of ICU patients with intra-abdominal candidiasis
Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the CandID PLUS PCR, using fungal culture as the reference standard.
Measured: Day of the surgery
Secondary outcomes (2)
To compare the diagnostic performance of the CandID PLUS PCR with that of peritoneal 1,3-β-D-glucan
Sensitivity, specificity, PPV, and NPV of peritoneal 1,3-β-D-glucan compared with fungal culture; diagnostic performance comparison between CandID PLUS PCR and 1,3-β-D-glucan (including ROC curve analysis)
Measured: Day of the surgery
To explore the association between PCR cycle threshold (Ct) values (as a proxy for fungal load) and clinical parameters, including SOFA score and ICU mortality
Association between PCR Ct values and clinical severity (SOFA score) and ICU mortality
Measured: Day 1 (surgery) to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start17 Apr 2025
- Primary completion17 Apr 2025
- Study completion17 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intra-Abdominal InfectionStudies 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
- 88 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
- NCT07005258
- Sponsor's protocol ID
- 2025PI060
- Acronym
- CANDIDIAG
- Status last verified
- Apr 2025
- First submitted
- 3 Jun 2025
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Diagnostic Performance of the CandID PLUS PCR for the Detection of Candida Spp. in Peritoneal Fluid of Critically Ill Patients With Suspected Intra-abdominal Candidiasis
- ClinicalTrials.gov ID
- NCT07005258
- Acronym / sponsor ID
- CANDIDIAG / 2025PI060
- Conditions
- Intra-Abdominal Infection, Candida, Peritonitis Infectious, Molecular Diagnostic, Critically Ill Intensive Care Unit Patients
- Keywords
- intra-abdominal candidiasis, secondary peritonitis, candida, PCR, molecular diagnostic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 17 Apr 2025 (actual)
- Primary completion
- 17 Apr 2025 (actual)
- Study completion
- 17 Apr 2025 (actual)
- First posted
- 5 Jun 2025 (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.
Invasive candidiasis are the most common form of fungal infection in critically ill patients, particularly intra-abdominal candidiasis (IAC), which is associated with high morbidity and mortality. The current diagnostic gold standard relies on conventional fungal culture, which has a long turnaround time and may delay targeted antifungal therapy. Non-culture-based assays such as 1,3-β-D-glucan lack specificity for early and definitive diagnosis. Molecular diagnostics, including PCR, offer faster and more specific detection, but their clinical use remains limited.
The CandID PLUS PCR assay targets major Candida species and has not yet been evaluated on peritoneal fluid.
The CANDIDIAG study aims to assess the feasibility and diagnostic performance of the CandID PLUS PCR in detecting Candida spp. in peritoneal fluid from ICU patients with suspected IAC.
This study constitutes a post-hoc analysis of the pBDG2 study (Prospective evaluation of the peritoneal 1.3 Beta-D-glucan for the diagnosis of intra-abdominal candidiasis in the critically ill patients) registered with the number NCT 03997929). Therefore, all patients have been already recruited. For the CANDIDIAG study, we will use the biological collection of peritoneal fluid issue from the pBDG2 study. All patients with confirmed intra-abdominal candidiasis are identified. We will test de CandID PCR, retrospectively, on their peritoneal fluid and compared the results with the fungal culture.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critically ill patients with intra-abdominal candidiasis requiring abdominal surgery | – | –All patients have confirmed intra-abdominal candidiasis (positive Candida culture) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The pBDG2 study enrolled 199 ICU patients across four participating centers. Inclusion criteria were: adult ICU patients with suspected intra-abdominal infection likely due to Candida spp., requiring emergency abdominal surgery. Among the enrolled patients, 88 were diagnosed with confirmed intra-abdominal candidiasis based on positive fungal culture. Only these 88 patients will be eligible for inclusion in the CANDIDIAG study. This constitutes a post-hoc analysis of a predefined subpopulation from the pBDG2 cohort. Participating centers included the University Hospitals of Nancy, Dijon, Strasbourg, and the Regional Hospital Center of Metz (CHR Metz)
Key inclusion criteria (4 listed)
- adult critically ill patient
- with confirmed intra-abdominal candidiasis (culture positive with Candida albicans, glabrata, parapsilosis, tropicalis, krusei, and dubliniensis)
- enrolled in the pBDG2 study (NCT 03997929)
- intra-abdominal candidiasis documented at
Key exclusion criteria (2 listed)
- Declined to participate
- intra-abdominal candidiasis caused by other candida species
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To evaluate the diagnostic performance of the CandID PLUS PCR for the detection of Candida albicans, glabrata, parapsilosis, tropicalis, krusei, and dubliniensis in peritoneal fluid of ICU patients with intra-abdominal candidiasis
Time frame: Day of the surgery
Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the CandID PLUS PCR, using fungal culture as the reference standard.
2 secondary outcomes
To compare the diagnostic performance of the CandID PLUS PCR with that of peritoneal 1,3-β-D-glucan
Time frame: Day of the surgery
To explore the association between PCR cycle threshold (Ct) values (as a proxy for fungal load) and clinical parameters, including SOFA score and ICU mortality
Time frame: Day 1 (surgery) to Day 28
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 5 Jun 2025.
- Individual participant dataSharing planned: No
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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 Intra-Abdominal Infection and Candida, 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 4 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 5 Jun 2025. 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?
To evaluate the diagnostic performance of the CandID PLUS PCR for the detection of Candida albicans, glabrata, parapsilosis, tropicalis, krusei, and dubliniensis in peritoneal fluid of ICU patients with intra-abdominal candidiasis (time frame: Day of the surgery). 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 5 Jun 2025.