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

Infection, Fungal Clinical Trial

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

Status Recruiting

Clinical 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.

The dosage of BDG will be considered positive if the value is at least or equal to 80 pg/ml.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Candidemia
• Infection, Fungal
• Mycoses

• NCT number: NCT03674359
• Study type: Observational
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Philippe KAROUBI, MD
• Phone: +33 1 48 95 21 96
• Email: philippe.karoubi@aphp.fr
• Status: Recruiting
• Start date: December 12, 2018
• Completion date: March 2022