Management of Parapneumonic Pleurisy Guided by an Early Pleural Ultrasound

Completed

• Conditions: Community-Acquired Infections

• Registration Number: NCT04348734
• Lead Sponsor: Central Hospital Saint Quentin

Brief Summary

Parapneumonic pleurisies are a frequent complication of pneumopathies, but therapeutic management is poorly codified. Only the indication of thoracic drainage has benefited from expert recommendations. However, we find in the literature the major importance of early management of infectious pleurisy in order to minimize the sequelae. Pleural ultrasound, sensitive and specific in this pathology could bring us a real interest in terms of diagnostic speed and therefore of care. This study therefore seeks to show that pleural ultrasound can have a major interest in improving the management of patients with parapneumonic pleurisy, by reducing the number of medical treatment failures.

Detailed Description

This is a prospective, multicentre, non-randomized study evaluating routine care, which includes all patients hospitalized in the departments participating in the study, for pneumonia with or without pleurisy. Patients benefiting from a daily pleural ultrasound for 96 hours, D1 being the day of hospitalization. The therapeutic course of action will depend on the presence or not, and on the type of pleural effusion according to a pre-established algorithm. In case of pleural effusion of type 1, the type of treatment will be left to the appreciation of the clinician (puncture or drainage), in case of pleural effusion of type 2, 3 or 4 the patient benefited from pleural drainage.

Patients included in the study will benefit from a pleural ultrasound on the day of their hospitalization, up to 96 hours after treatment. Ultrasound will then allow us to look for the presence of pleural effusion. In the event of effusion corresponding to a parapneumonic effusion or purulent pleurisy, the conduct to be followed will be defined according to the ultrasound type of effusion. Types 1 will benefit from an evacuating pleural puncture or drainage, depending on the clinician's judgment. Types 2, 3, and 4 will benefit from weeping drainage.

the target population: adult patients, hospitalized for pneumonia or confirmed pleurisy, by imaging and exploratory pleural puncture in the departments participating in the study over the period concerned The main outcome measure is the failure of medical treatment, defined as the need to resort to surgery, with or without peeling, or death secondary to pleurisy. The secondary endpoint is the presence of radiological sequelae at 3 months and 6 months defined by a retraction of the hemithorax concerned with pachypleuritis or an ascent of the diaphragmatic dome or the persistence of pleurisy

Study Timeline

• Study Start: 2016-05-04
• Status Verified: 2020-03
• Study First Submitted: 2020-03-30
• Study First Submitted QC: 2020-04-14
• Study First Posted: 2020-04-16
• Primary Completion: 2020-05-04
• Study Completion: 2020-05-04
• Last Update Submitted: 2020-07-13
• Last Update Posted: 2020-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 115

Inclusion Criteria

• adult patients, hospitalized for pneumonia or confirmed pleurisy, by imaging and exploratory pleural puncture.
• Patients affiliated to social security

Exclusion Criteria

• patients with transudative pleurisy,
• patients with exudative pleurisy in the context of pulmonary neoplasia or tuberculosis,
• patients with pneumonectomy compartment infections,
• Patient under guardianship or curatorship,
• Subjects under 18 years of age,
• Pregnant women,
• patients in emergency situations

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
interet de l'échographie pleurale dans les pleurésies parapneumoniques	1 year	Evaluate the failure of medical treatment, defined as the need to resort to surgery, or death secondary to pleuris

Secondary Outcome Measures

Name	Time	Method
presence radiological sequelae a pleural effusion at 6 months	6 months	the presence of radiological sequelae at 6 months defined by a retraction of the hemithorax concerned with pachypleuritis or an ascent of the diaphragmatic dome or the persistence of a pleural effusion
presence radiological sequelae a pleural effusion at 3 months	3 months	the presence of radiological sequelae at 3 months defined by a retraction of the hemithorax concerned with pachypleuritis or an ascent of the diaphragmatic dome or the persistence of a pleural effusion

Trial Locations

Locations (4)

Chu Amiens; 🇫🇷 Amiens, France

CH Pontoise; 🇫🇷 Cergy-Pontoise, France

Saint-Quentin Hospital; 🇫🇷 Saint-Quentin, France

CH Creteil; 🇫🇷 Créteil, France