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. (EMPIRICAND)

February 19, 2024 updated by: Centre Hospitalier Universitaire Dijon

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Dijon, France, 21000
        • CHU de DIJON

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

patients in a medical Intensive Care Patients with suspected invasive candidiasis

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients with suspected invasive candidiasis
Biological: 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
At day 1, day 5 and day 10 after the start of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 12, 2015

Primary Completion (Actual)

September 17, 2019

Study Completion (Actual)

September 17, 2019

Study Registration Dates

First Submitted

December 5, 2014

First Submitted That Met QC Criteria

January 5, 2015

First Posted (Estimated)

January 7, 2015

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 19, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Charles MSD 2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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