Back to resultsImprovement of the Etiological Diagnosis of the Pericarditis (PERICARDITE)
Primary Purpose
Infective Pericarditis
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Nasal swab
Sponsored by
About this trial
This is an interventional diagnostic trial for Infective Pericarditis
Eligibility Criteria
Inclusion Criteria:
- Patient prescribed with a pericarditis kit for etiological diagnosis of a pericardial syndrome.
- Adult patient (= or > 18 years old)
- Patient who freely signed the informed consent form.
- Patient affiliated to a health insurance regime
Exclusion Criteria:
- Minor patient ( age <18 years)
- Pregnant, parturient or breastfeeding woman
- Adult patient incapable or unable to consent
- Patient deprived of liberty under judgment
- Person living in a health or social specialised structure
- Person in vital emergency situation
Sites / Locations
- Assistance Publique Hopitaux de Marseille
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Infective Pericarditis
Arm Description
In patient prescribed with a pericardite kit for an etiological diagnosis of a pericardial syndrome, an additional nasal swab will be performed in order to perform a specific diagnosis with PCR technique.
Outcomes
Primary Outcome Measures
Percentage of pericarditis whose etiological diagnosis has been established.
Secondary Outcome Measures
Identification of the detected emerging pathogens among infectious causesof pericarditis
Prevalence of the emerging pathogens: assessement of the percentage of emerging pathogens among the studied population
Full Information
NCT ID
NCT02828085
First Posted
June 30, 2016
Last Updated
April 20, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT02828085
Brief Title
Improvement of the Etiological Diagnosis of the Pericarditis
Acronym
PERICARDITE
Official Title
Improvement of the Etiological Diagnosis of the Pericarditis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
July 7, 2013 (Actual)
Primary Completion Date
July 24, 2019 (Actual)
Study Completion Date
October 26, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
5. Study Description
Brief Summary
Pericardial syndrome includes pericardites acute pericardial effusion and cardiac tamponade, recurrent pericarditis squeezing chronic pericarditis. The etiologies are very numerous and can be classified as infectious, neoplastic, metabolic or systemic, toxic causes. Diagnosis is difficult, and 80% of etiologies remain classified idiopathic. In their laboratory to improve the diagnosis of this syndrome investigators have developed a strategy of systematic prescription of biological tests by kit. This prescription by 'kit' strategy proved its interest by comparison with an intuitive requirement of biological. In this study investigators want to improve the diagnostic causative of pericarditis by implementing a new diagnostic strategy. This new strategy includes (i) samples additional less invasive for the patient, the swab pharyngeal and nasal, (ii) the addition of at the outset of more effective diagnostic techniques: specific Polymerase Chain Reaction (PCR)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infective Pericarditis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
979 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Infective Pericarditis
Arm Type
Other
Arm Description
In patient prescribed with a pericardite kit for an etiological diagnosis of a pericardial syndrome, an additional nasal swab will be performed in order to perform a specific diagnosis with PCR technique.
Intervention Type
Biological
Intervention Name(s)
Nasal swab
Intervention Description
Nasal swab will be performed in addition to the routine diagnosis visit in order to determine the diagnosis of infective pericardite with a more specific technique: PCR
Primary Outcome Measure Information:
Title
Percentage of pericarditis whose etiological diagnosis has been established.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Identification of the detected emerging pathogens among infectious causesof pericarditis
Time Frame
1 day
Title
Prevalence of the emerging pathogens: assessement of the percentage of emerging pathogens among the studied population
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient prescribed with a pericarditis kit for etiological diagnosis of a pericardial syndrome.
Adult patient (= or > 18 years old)
Patient who freely signed the informed consent form.
Patient affiliated to a health insurance regime
Exclusion Criteria:
Minor patient ( age <18 years)
Pregnant, parturient or breastfeeding woman
Adult patient incapable or unable to consent
Patient deprived of liberty under judgment
Person living in a health or social specialised structure
Person in vital emergency situation
Facility Information:
Facility Name
Assistance Publique Hopitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France
12. IPD Sharing Statement
Learn more about this trial
Improvement of the Etiological Diagnosis of the Pericarditis
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