Clinical trial NCT02333448: 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.
Official title: Diagnostic Value of PCR Genetic Amplification and Mannan Antigenemia Coupled With Antimannan Antibodies in Intensive Care Patients With Suspected Invasive Candidiasis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Invasive Candidiasis; Treatment With Echinocandin
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2015-01-07
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients in a medical Intensive Care Patients with suspected invasive candidiasis

Brief 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.


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

Primary outcomes:
measure: Change from the start of treatment in genomic DNA of Candida sp. by quantitative PCR
timeFrame: At day 1, day 3, day 5, Day 7 and Day 10 after the start of antifungal treatment with echinocandin.
Secondary outcomes:
measure: Change from the start of treatment in mannan antigenemia and antimannan antibodies
timeFrame: At day 1, day 5 and day 10 after the start of treatment
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU de DIJON
Study officials:
References: