Clinical trial

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

Name
Charles MSD 2014
Description
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.
Trial arms
Trial start
2015-06-12
Estimated PCD
2019-09-17
Trial end
2019-09-17
Status
Completed
Treatment
Blood sample taken on the day the treatment is initiated
Arms:
patients with suspected invasive candidiasis
Blood sample taken on day 3 after initiation of treatment
Arms:
patients with suspected invasive candidiasis
Blood sample taken on day 5 after initiation of
Arms:
patients with suspected invasive candidiasis
Blood sample taken on day 7 after initiation of treatment
Arms:
patients with suspected invasive candidiasis
Blood sample taken on day 10 after initiation of treatment
Arms:
patients with suspected invasive candidiasis
Size
80
Primary endpoint
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.
Eligibility criteria
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
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_ONLY', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 80, 'type': 'ACTUAL'}}
Updated at
2024-02-20

1 organization

1 product

1 indication