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Dosage of Plasma 1, 3-β-D-glucan for the Diagnosis of Candidemia.

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03674359
Acronym
BDG-REA
Enrollment
2000
Registered
2018-09-17
Start date
2018-12-12
Completion date
2022-03-31
Last updated
2021-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection, Fungal

Keywords

1, 3-β-D-glucan, Candidemia, Intensive Care Unit

Brief 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. 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.

Interventions

DIAGNOSTIC_TESTBDG analysis

BDG analysis

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Determine the sensitivity and specificity of the BDG for the diagnosis of candidemia in intensive care unit patients.30 day after inclusionSystematic 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.

Countries

France

Contacts

Primary ContactPhilippe KAROUBI, MD
philippe.karoubi@aphp.fr+33 1 48 95 21 96
Backup ContactMohammed RAHAOUI, PM
mohammed.rahaoui@aphp.fr+33 1 48 95 74 71

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026