Infection, FungalBDG-REANCT03674359
Dosage of Plasma 1, 3-β-D-glucan for the Diagnosis of Candidemia.
An observational study of Infection, Fungal, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial summary
Systematic and repeated dosing (3 times weekly) of 1,3-β-D-glucan (BDG), associated with blood cultures and fungal mapping (twice a week) for the patients hospitalized in intensive care. The diagnosis of candidemia is defined as the 1st positive blood culture for Candida spp. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection, Fungal
- What is being tested?
- BDG analysis
- How many people
- 2,000 participants
- Where
- 2 sitesFrance
- Study dates
- 12 Dec 2018to Mar 2022
- 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: Patients aged over 18, hospitalized in intensive care unit, under mechanical ventilation, antibiotics and with a central venous catheter, excluding pregnant or breastfeeding women.
Who may be able to join
- Patients ≥ 18 years
- Patients Under mechanical ventilation (MV), antibiotic (AB) And with a central venous catheter (CVK)
- inclusion at day 4 of hospitalization or from establishing of antifungal treatment between admission to the Intensive Care Unit (ICU) and day 4
- Affiliation to the social security system.
- Signed informed consent
Who cannot join
- Antifungal therapy at the admission in intensive care unit
- Patient whose inclusion life expectancy is less than 72 h
- Patient being treated for Pneumocystis carinii pneumonia (PCP)
- Pregnant or breastfeeding woman
- Neutropenia: < 500 nuclear neutrophil / mm3
- Patients under ECMO
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
Hopital Avicenne
Bobigny, 93000
Philippe KAROUBI, Dr
- Recruiting
Hôpital Louis Mourier
Colombes, 92701
Damien ROUX, Pr
About this study
Official title: Performance of the Dosage of Plasma 1, 3-β-D-glucan (BDG) for the Diagnosis of Candidemia in Intensive Care Patients: A Prospective, Multicenter Study
Systematic and repeated dosing (3 times weekly) of 1,3-β-D-glucan (BDG), associated with blood cultures and fungal mapping (twice a week) for the patients hospitalized in intensive care. The diagnosis of candidemia is defined as the 1st positive blood culture for Candida spp.
The dosage of BDG will be considered positive if the value is at least or equal to 80 pg/ml.
Read the detailed description
The candidemia is the 3rd cause of sepsis in intensive care unit and a serious problem because the high mortality remains (> 50%) despite the new treatments by echinocandins.
A single positive blood culture is sufficient for diagnosis, but the sensitivity of blood cultures is only 50 to 70 percent. Clinical signs are unspecific and do not guide the diagnosis. If treatment started early, 12 hours after the 1st positive blood culture collection the mortality is 10%. Recently, the incidence of candidemia in intensive care unit has increased in France as in other countries as. From these different elements (frequency, mortality, early diagnosis, little specific clinical signs), it is easy to understand the approach that has prevailed for many years, which is to define the profile of the patients at risk of candidemia in intensive care unit. Currently, there are several predictive factors of occurrence of a candidemia in intensive care unit. They are represented by the index of colonization, very high risk factors (FTHR) and Candida score (CS).
Predictive factors of occurrence of candidemia have led to the concept of preemptive or empirical treatment, the aim is to being avoid the occurrence of candidemia.
However, the ability of these factors to predict the occurrence of a candidemia is not satisfactory, explaining in part the mortality rate.
In the light of current knowledge, including the predictive factors of occurrence of candidemia in intensive care patients, a better selection of patients likely to develop candidemia remains to this day, a crucial issue. Several teams have been interested in the evaluation of various bio-markers, including the (1,3) - β - D-glucan (BDG), to optimize decision-making in intensive care patients at risk of candidemia in front of:
- the increased frequency of candidemia,
- poorly discriminating predictive factors,
- no specific clinical signs,
- the low sensitivity of blood culture,
- and the impact of early treatment.
To clarify the role of BDG as a predictive factor of candidemia, all patients hospitalized in intensive care unit, meeting the criteria for inclusion and exclusion, will be followed, from day 4 of hospitalization or from the beginning of antifungal treatment between the admission in intensive care unit and day 4, until the exit of intensive care unit or until day30 of hospitalization in intensive care unit.
The dosage of BDG and blood cultures will be performed on day 4 of hospitalization or before the beginning of antifungal treatment between the admission in intensive care unit and the 4th day, then 3 times a week, until day 30.
A before the beginning of antifungal treatment between the admission to intensive care unit and the 4th day of hospitalization, then twice a week, maximum until day30.
- Conditions
- Infection, Fungal
- Being tested
- BDG analysis
- Keywords
- 1, 3-β-D-glucan, Candidemia, Intensive Care Unit
- Medical subject headings
- Mycoses, Candidemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BDG analysisDiagnostic test
BDG analysis
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Patients hospitalized in intensive care, meeting the inclusion criteria. BDG analysis Receives: Diagnostic Test: BDG analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the sensitivity and specificity of the BDG for the diagnosis of candidemia in intensive care unit patients.
Systematic and repeated dosing , for the diagnosis of candidemia (1st positive blood culture for Candida spp).
Dosage of BDG will be considered positive if a dosage is at least equal to 80 pg/ml or greater.
Measured: 30 day after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study start12 Dec 2018
- Primary completionSep 2021 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Infection, FungalStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe KAROUBI, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03674359
- Sponsor's protocol ID
- P170926J
- Acronym
- BDG-REA
- Status last verified
- Dec 2020
- First submitted
- 10 Sep 2018
- Last updated
- 26 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lortholary O, Renaudat C, Sitbon K, Madec Y, Denoeud-Ndam L, Wolff M, Fontanet A, Bretagne S, Dromer F; French Mycosis Study Group. Worrisome trends in incidence and mortality of candidemia in intensive care units (Paris area, 2002-2010). Intensive Care Med. 2014 Sep;40(9):1303-12. doi: 10.1007/s00134-014-3408-3. Epub 2014 Aug 6.
PubMed 25097069Clancy CJ, Nguyen MH. Finding the "missing 50%" of invasive candidiasis: how nonculture diagnostics will improve understanding of disease spectrum and transform patient care. Clin Infect Dis. 2013 May;56(9):1284-92. doi: 10.1093/cid/cit006. Epub 2013 Jan 11.
PubMed 23315320Morrell M, Fraser VJ, Kollef MH. Delaying the empiric treatment of candida bloodstream infection until positive blood culture results are obtained: a potential risk factor for hospital mortality. Antimicrob Agents Chemother. 2005 Sep;49(9):3640-5. doi: 10.1128/AAC.49.9.3640-3645.2005.
PubMed 16127033Posteraro B, De Pascale G, Tumbarello M, Torelli R, Pennisi MA, Bello G, Maviglia R, Fadda G, Sanguinetti M, Antonelli M. Early diagnosis of candidemia in intensive care unit patients with sepsis: a prospective comparison of (1-->3)-beta-D-glucan assay, Candida score, and colonization index. Crit Care. 2011;15(5):R249. doi: 10.1186/cc10507. Epub 2011 Oct 22.
PubMed 22018278
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of the Dosage of Plasma 1, 3-β-D-glucan (BDG) for the Diagnosis of Candidemia in Intensive Care Patients: A Prospective, Multicenter Study
- ClinicalTrials.gov ID
- NCT03674359
- Acronym / sponsor ID
- BDG-REA / P170926J
- Conditions
- Infection, Fungal
- Keywords
- 1, 3-β-D-glucan, Candidemia, Intensive Care Unit
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 12 Dec 2018 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 17 Sep 2018 (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.
Systematic and repeated dosing (3 times weekly) of 1,3-β-D-glucan (BDG), associated with blood cultures and fungal mapping (twice a week) for the patients hospitalized in intensive care. The diagnosis of candidemia is defined as the 1st positive blood culture for Candida spp.
The dosage of BDG will be considered positive if the value is at least or equal to 80 pg/ml.
Detailed description
The candidemia is the 3rd cause of sepsis in intensive care unit and a serious problem because the high mortality remains (> 50%) despite the new treatments by echinocandins.
A single positive blood culture is sufficient for diagnosis, but the sensitivity of blood cultures is only 50 to 70 percent. Clinical signs are unspecific and do not guide the diagnosis. If treatment started early, 12 hours after the 1st positive blood culture collection the mortality is 10%. Recently, the incidence of candidemia in intensive care unit has increased in France as in other countries as. From these different elements (frequency, mortality, early diagnosis, little specific clinical signs), it is easy to understand the approach that has prevailed for many years, which is to define the profile of the patients at risk of candidemia in intensive care unit. Currently, there are several predictive factors of occurrence of a candidemia in intensive care unit. They are represented by the index of colonization, very high risk factors (FTHR) and Candida score (CS).
Predictive factors of occurrence of candidemia have led to the concept of preemptive or empirical treatment, the aim is to being avoid the occurrence of candidemia.
However, the ability of these factors to predict the occurrence of a candidemia is not satisfactory, explaining in part the mortality rate.
In the light of current knowledge, including the predictive factors of occurrence of candidemia in intensive care patients, a better selection of patients likely to develop candidemia remains to this day, a crucial issue. Several teams have been interested in the evaluation of various bio-markers, including the (1,3) - β - D-glucan (BDG), to optimize decision-making in intensive care patients at risk of candidemia in front of:
- the increased frequency of candidemia,
- poorly discriminating predictive factors,
- no specific clinical signs,
- the low sensitivity of blood culture,
- and the impact of early treatment.
To clarify the role of BDG as a predictive factor of candidemia, all patients hospitalized in intensive care unit, meeting the criteria for inclusion and exclusion, will be followed, from day 4 of hospitalization or from the beginning of antifungal treatment between the admission in intensive care unit and day 4, until the exit of intensive care unit or until day30 of hospitalization in intensive care unit.
The dosage of BDG and blood cultures will be performed on day 4 of hospitalization or before the beginning of antifungal treatment between the admission in intensive care unit and the 4th day, then 3 times a week, until day 30.
A before the beginning of antifungal treatment between the admission to intensive care unit and the 4th day of hospitalization, then twice a week, maximum until day30.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | Diagnostic Test: BDG analysisPatients hospitalized in intensive care, meeting the inclusion criteria. BDG analysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged over 18, hospitalized in intensive care unit, under mechanical ventilation, antibiotics and with a central venous catheter, excluding pregnant or breastfeeding women.
Key inclusion criteria (5 listed)
- Patients ≥ 18 years
- Patients Under mechanical ventilation (MV), antibiotic (AB) And with a central venous catheter (CVK)
- inclusion at day 4 of hospitalization or from establishing of antifungal treatment between admission to the Intensive Care Unit (ICU) and day 4
- Affiliation to the social security system.
- Signed informed consent
Key exclusion criteria (6 listed)
- Antifungal therapy at the admission in intensive care unit
- Patient whose inclusion life expectancy is less than 72 h
- Patient being treated for Pneumocystis carinii pneumonia (PCP)
- Pregnant or breastfeeding woman
- Neutropenia: < 500 nuclear neutrophil / mm3
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 |
|---|---|---|
| BDG analysisBDG analysis | Diagnostic test | Cohort |
Primary outcome
Determine the sensitivity and specificity of the BDG for the diagnosis of candidemia in intensive care unit patients.
Time frame: 30 day after inclusion
Systematic and repeated dosing , for the diagnosis of candidemia (1st positive blood culture for Candida spp). Dosage of BDG will be considered positive if a dosage is at least equal to 80 pg/ml or greater.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2021.
- Results publication: PubMed 25097069Lortholary O, Renaudat C, Sitbon K, Madec Y, Denoeud-Ndam L, Wolff M, Fontanet A, Bretagne S, Dromer F; French Mycosis Study Group. Worrisome trends in incidence and mortality of candidemia in intensive care units (Paris area, 2002-2010). Intensive Care Med. 2014 Sep;40(9):1303-12. doi: 10.1007/s00134-014-3408-3. Epub 2014 Aug 6.
- Results publication: PubMed 23315320Clancy CJ, Nguyen MH. Finding the "missing 50%" of invasive candidiasis: how nonculture diagnostics will improve understanding of disease spectrum and transform patient care. Clin Infect Dis. 2013 May;56(9):1284-92. doi: 10.1093/cid/cit006. Epub 2013 Jan 11.
- Results publication: PubMed 16127033Morrell M, Fraser VJ, Kollef MH. Delaying the empiric treatment of candida bloodstream infection until positive blood culture results are obtained: a potential risk factor for hospital mortality. Antimicrob Agents Chemother. 2005 Sep;49(9):3640-5. doi: 10.1128/AAC.49.9.3640-3645.2005.
- Results publication: PubMed 22018278Posteraro B, De Pascale G, Tumbarello M, Torelli R, Pennisi MA, Bello G, Maviglia R, Fadda G, Sanguinetti M, Antonelli M. Early diagnosis of candidemia in intensive care unit patients with sepsis: a prospective comparison of (1-->3)-beta-D-glucan assay, Candida score, and colonization index. Crit Care. 2011;15(5):R249. doi: 10.1186/cc10507. Epub 2011 Oct 22.
- Individual participant dataSharing planned: Undecided
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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.
Philippe KAROUBI, MD principal investigator
Assistance Publique - Hôpitaux de Paris
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infection, Fungal, run by Assistance Publique - Hôpitaux de Paris at 2 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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 26 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philippe KAROUBI, MD (+33 1 48 95 21 96, philippe.karoubi@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the sensitivity and specificity of the BDG for the diagnosis of candidemia in intensive care unit patients. (time frame: 30 day after inclusion). 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 NCT03674359, which also lists 4 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 26 Jan 2021; AzTrials last refreshed its copy on 7 Nov 2026.