Improvement of the Etiological Diagnosis of the Pericarditis

Not Applicable

Completed

• Conditions: Infective Pericarditis
• Interventions: Biological: Nasal swab

• Registration Number: NCT02828085
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07-07
• Study First Submitted: 2016-06-30
• Study First Submitted QC: 2016-07-06
• Study First Posted: 2016-07-11
• Primary Completion: 2019-07-24
• Study Completion: 2022-10-26
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-20
• Last Update Posted: 2023-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 979

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Infective Pericarditis	Nasal swab	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.

Primary Outcome Measures

Name	Time	Method
Percentage of pericarditis whose etiological diagnosis has been established.	1 day

Secondary Outcome Measures

Name	Time	Method
Identification of the detected emerging pathogens among infectious causesof pericarditis	1 day
Prevalence of the emerging pathogens: assessement of the percentage of emerging pathogens among the studied population	1 day

Trial Locations

Locations (1)

Assistance Publique Hopitaux de Marseille; 🇫🇷 Marseille, France