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OpenTrials
Completed

NCT Number: 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.

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de DIJON

Dijon, 21000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sample taken on the day the treatment is initiated

Biological

Blood sample taken on day 3 after initiation of treatment

Biological

Blood sample taken on day 5 after initiation of

Biological

Blood sample taken on day 7 after initiation of treatment

Biological

Blood sample taken on day 10 after initiation of treatment

Biological

Primary outcomes

  1. Change from the start of treatment in genomic DNA of Candida sp. by quantitative PCR

    Time frame: At day 1, day 3, day 5, Day 7 and Day 10 after the start of antifungal treatment with echinocandin.

Secondary outcomes

  1. Change from the start of treatment in mannan antigenemia and antimannan antibodies

    Time frame: At day 1, day 5 and day 10 after the start of treatment

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Official study title

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

Acronym: EMPIRICAND

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jan 7, 2015
Registry last updated
Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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