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.

NCT ID: NCT02333448

Last Updated: 2024-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-12

Study Completion Date

2019-09-17

Brief Summary

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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.

Detailed Description

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Conditions

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Invasive Candidiasis; Treatment With Echinocandin

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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patients with suspected invasive candidiasis

Blood sample taken on the day the treatment is initiated

Intervention Type BIOLOGICAL

Blood sample taken on day 3 after initiation of treatment

Intervention Type BIOLOGICAL

Blood sample taken on day 5 after initiation of

Intervention Type BIOLOGICAL

Blood sample taken on day 7 after initiation of treatment

Intervention Type BIOLOGICAL

Blood sample taken on day 10 after initiation of treatment

Intervention Type BIOLOGICAL

Interventions

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Blood sample taken on the day the treatment is initiated

Intervention Type BIOLOGICAL

Blood sample taken on day 3 after initiation of treatment

Intervention Type BIOLOGICAL

Blood sample taken on day 5 after initiation of

Intervention Type BIOLOGICAL

Blood sample taken on day 7 after initiation of treatment

Intervention Type BIOLOGICAL

Blood sample taken on day 10 after initiation of treatment

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU de DIJON

Dijon, , France

Site Status

Countries

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France

Other Identifiers

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Charles MSD 2014

Identifier Type: -

Identifier Source: org_study_id

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