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.

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02333448

Acronym

EMPIRICAND

Enrollment

Registered

2015-01-07

Start date

2015-06-12

Completion date

2019-09-17

Last updated

2024-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Invasive Candidiasis; Treatment With Echinocandin

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.

Interventions

BIOLOGICALBlood sample taken on the day the treatment is initiated

BIOLOGICALBlood sample taken on day 3 after initiation of treatment

BIOLOGICALBlood sample taken on day 5 after initiation of

BIOLOGICALBlood sample taken on day 7 after initiation of treatment

BIOLOGICALBlood sample taken on day 10 after initiation of treatment

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026