Evaluate the Performance of Genetic Amplification by Polymerase Chain Reaction (PCR) and the "Mannan Antigenemia and Antimannan Antibodies Couple as a Means of Diagnosis and a Marker of Follow-up in Invasive Candidiasis.

Invasive Candidiasis; Treatment With Echinocandin Clinical Trial

— EMPIRICAND  

Official title:

Diagnostic Value of PCR Genetic Amplification and Mannan Antigenemia Coupled With Antimannan Antibodies in Intensive Care Patients With Suspected Invasive Candidiasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02333448
• Other study ID #: Charles MSD 2014
• Status: Completed
• Start date: June 12, 2015
• Est. completion date: September 17, 2019

Study information

• Verified date: February 2024
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study consists in taking 4 tubes of blood at different times over a period of 10 days, via a catheter (central venous or arterial catheter) already in place in the usual therapeutic management. These samples will make it possible to measure blood levels of certain markers specific to invasive candidiasis. PCR will be used to quantify fungal load precisely, that is to say the quantity of yeast present in the blood and to monitor this quantity over time.

These samples will be transferred to a specialized unit and stored for a maximum of three years for use at the end of the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 17, 2019
• Est. primary completion date: September 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient informed about the study

• Patients aged at least 18 years admitted to a medical Intensive Care or general intensive care

• Patients with suspected invasive candidiasis - that is to say:

• Presenting persistent sepsis despite broad-spectrum antibiotherapy for at least 48 hours or targeted antibiotherapy for a documented bacterial infection (sepsis will be defined according to:

• the usual SIRS criteria, at least 2 of the following 4: temperature > 38°C or < 36°C, tachycardia > 90/min, respiratory rate > 20/min or blood pressure carbon dioxide (PaCO2 ) < 32 mmHg, leukocytosis > 12000/mm3 or < 4000/mm3 or > 10% of immature forms.

• Persistent hemodynamic instability (impossibility to significantly diminish catecholamine requirement, need for rapid vascular resuscitation > 1000 ml over the previous 24 hours)

• Candida score = 3 with multifocal colonization

• Decision to initiate echinocandin therapy made by the clinician in charge of the patient

Exclusion Criteria:

• Treatment with echinocandin > 1 day in the week preceding inclusion

• Patients not covered by national health insurance

• Pregnant or breast-feeding women

Related Conditions & MeSH terms

• Candidiasis
• Candidiasis, Invasive
• Invasive Candidiasis; Treatment With Echinocandin

Intervention

Biological:
• Blood sample taken on the day the treatment is initiated

• Blood sample taken on day 3 after initiation of treatment

• Blood sample taken on day 5 after initiation of

• Blood sample taken on day 7 after initiation of treatment

• Blood sample taken on day 10 after initiation of treatment

Locations

Country	Name	City	State
France	CHU de DIJON	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from the start of treatment in genomic DNA of Candida sp. by quantitative PCR		At day 1, day 3, day 5, Day 7 and Day 10 after the start of antifungal treatment with echinocandin.
Secondary	Change from the start of treatment in mannan antigenemia and antimannan antibodies		At day 1, day 5 and day 10 after the start of treatment