Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02333448
Recruitment Status : Unknown
Verified October 2014 by Centre Hospitalier Universitaire Dijon.
Recruitment status was:  Recruiting
First Posted : January 7, 2015
Last Update Posted : January 7, 2015
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment
Invasive Candidiasis; Treatment With Echinocandin 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

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Diagnostic Value of PCR Genetic Amplification and Mannan Antigenemia Coupled With Antimannan Antibodies in Intensive Care Patients With Suspected Invasive Candidiasis
Study Start Date : October 2014
Estimated Primary Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Yeast Infections

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients in a medical Intensive Care Patients with suspected invasive candidiasis
Criteria

Inclusion Criteria:

  • Patient informed about the study patients aged at least 18 years admitted to a medical 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 Surgical patients: abdominal or digestive surgery in the month preceding inclusion Patients not covered by national health insurance Pregnant or breast-feeding women
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02333448


Contacts
Layout table for location contacts
Contact: Rémi BRUYERE 3 80 28 13 02 ext +33 remi.bruyere@chu-dijon.fr

Locations
Layout table for location information
France
CHU de DIJON Recruiting
Dijon, France, 21000
Contact: Rémi BRUYERE    3 80 28 13 02 ext +33    remi.bruyere@chu-dijon.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT02333448    
Other Study ID Numbers: Charles MSD 2014
First Posted: January 7, 2015    Key Record Dates
Last Update Posted: January 7, 2015
Last Verified: October 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Candidiasis
Candidiasis, Invasive
Mycoses
 Bacterial Infections and Mycoses
Infections
Invasive Fungal Infections