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

Infection, Fungal Clinical Trial

— BDG-REA  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03674359
• Other study ID #: P170926J
• Status: Recruiting
• Start date: December 12, 2018
• Est. completion date: March 2022

Study information

• Verified date: December 2020
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Philippe KAROUBI, MD
• Phone: +33 1 48 95 21 96
• Email: philippe.karoubi[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: March 2022
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Candidemia
• Infection, Fungal
• Mycoses

Intervention

Diagnostic Test:
• BDG analysis
BDG analysis

Locations

Country	Name	City	State
France	Hopital Avicenne	Bobigny
France	Hôpital Louis Mourier	Colombes

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (4)

Clancy 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 — View Citation

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 M — View Citation

Morrell 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. — View Citation

Posteraro 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)-ß-D-glucan assay, Candid — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	30 day after inclusion