Management of Parapneumonic Pleurisy Guided by an Early Pleural Ultrasound

Community-Acquired Infections Clinical Trial

— ECHOPP  

Official title:

Management of Parapneumonic Pleurisy Guided by an Early Pleural Ultrasound

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04348734
• Other study ID #: 2015-A00993-46
• Status: Completed
• Start date: May 4, 2016
• Est. completion date: May 4, 2020

Study information

• Verified date: March 2020
• Source: Central Hospital Saint Quentin
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: May 4, 2020
• Est. primary completion date: May 4, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Community-Acquired Infections
• Pleurisy

Intervention

Diagnostic Test:
• pleural ultrasound
Patients will benefit 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

Locations

Country	Name	City	State
France	Chu Amiens	Amiens
France	CH Pontoise	Cergy-Pontoise
France	CH Creteil	Créteil
France	Saint-Quentin Hospital	Saint-Quentin

Sponsors (2)

Lead Sponsor	Collaborator
Central Hospital Saint Quentin	Amiens University Hospital

Country where clinical trial is conducted

France, 

References & Publications (17)

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Ramnath RR, Heller RM, Ben-Ami T, Miller MA, Campbell P, Neblett WW 3rd, Holcomb GW, Hernanz-Schulman M. Implications of early sonographic evaluation of parapneumonic effusions in children with pneumonia. Pediatrics. 1998 Jan;101(1 Pt 1):68-71. — View Citation

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Taryle DA, Potts DE, Sahn SA. The incidence and clinical correlates of parapneumonic effusions in pneumococcal pneumonia. Chest. 1978 Aug;74(2):170-3. — View Citation

Tokuda Y, Matsushima D, Stein GH, Miyagi S. Intrapleural fibrinolytic agents for empyema and complicated parapneumonic effusions: a meta-analysis. Chest. 2006 Mar;129(3):783-90. — View Citation

Xirouchaki N, Magkanas E, Vaporidi K, Kondili E, Plataki M, Patrianakos A, Akoumianaki E, Georgopoulos D. Lung ultrasound in critically ill patients: comparison with bedside chest radiography. Intensive Care Med. 2011 Sep;37(9):1488-93. doi: 10.1007/s0013 — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	interet de l'échographie pleurale dans les pleurésies parapneumoniques	Evaluate the failure of medical treatment, defined as the need to resort to surgery, or death secondary to pleuris	1 year
Secondary	presence radiological sequelae a pleural effusion at 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	3 months
Secondary	presence radiological sequelae a pleural effusion at 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	6 months