NCT04348734

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2016

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 4, 2016

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

March 30, 2020

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 16, 2020

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 4, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 4, 2020

Completed
Last Updated

July 14, 2020

Status Verified

March 1, 2020

Enrollment Period

4 years

First QC Date

March 30, 2020

Last Update Submit

July 13, 2020

Conditions

Community-Acquired Infections

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • presence radiological sequelae a pleural effusion at 3 months

    3 months

  • presence radiological sequelae a pleural effusion at 6 months

    6 months

Interventions

pleural ultrasoundDIAGNOSTIC_TEST

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

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients hospitalized for pneumonia

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Chu Amiens

Amiens, 80000, France

Location

CH Pontoise

Cergy-Pontoise, France

Location

CH Creteil

Créteil, France

Location

Saint-Quentin Hospital

Saint-Quentin, 02100, France

Location

Related Publications (17)

  • Light RW. Pleural diseases. Curr Opin Pulm Med. 2003 Jul;9(4):251-3. doi: 10.1097/00063198-200307000-00001. No abstract available.

    PMID: 12806235RESULT

  • Miserocchi G. Physiology and pathophysiology of pleural fluid turnover. Eur Respir J. 1997 Jan;10(1):219-25. doi: 10.1183/09031936.97.10010219.

    PMID: 9032518RESULT

  • Davies CW, Gleeson FV, Davies RJ; Pleural Diseases Group, Standards of Care Committee, British Thoracic Society. BTS guidelines for the management of pleural infection. Thorax. 2003 May;58 Suppl 2(Suppl 2):ii18-28. doi: 10.1136/thorax.58.suppl_2.ii18. No abstract available.

    PMID: 12728147RESULT

  • Hamm H, Light RW. Parapneumonic effusion and empyema. Eur Respir J. 1997 May;10(5):1150-6. doi: 10.1183/09031936.97.10051150.

    PMID: 9163661RESULT

  • LeMense GP, Strange C, Sahn SA. Empyema thoracis. Therapeutic management and outcome. Chest. 1995 Jun;107(6):1532-7. doi: 10.1378/chest.107.6.1532.

    PMID: 7781342RESULT

  • Bober K, Swietlinski J. Diagnostic utility of ultrasonography for respiratory distress syndrome in neonates. Med Sci Monit. 2006 Oct;12(10):CR440-6. Epub 2006 Sep 25.

    PMID: 17006405RESULT

  • Soldati G, Sher S. Bedside lung ultrasound in critical care practice. Minerva Anestesiol. 2009 Sep;75(9):509-17.

    PMID: 19644435RESULT

  • 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. doi: 10.1542/peds.101.1.68.

    PMID: 9417153RESULT

  • 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/s00134-011-2317-y. Epub 2011 Aug 2.

    PMID: 21809107RESULT

  • 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. doi: 10.1378/chest.129.3.783.

    PMID: 16537882RESULT

  • Stavas J, vanSonnenberg E, Casola G, Wittich GR. Percutaneous drainage of infected and noninfected thoracic fluid collections. J Thorac Imaging. 1987 Jul;2(3):80-7. doi: 10.1097/00005382-198707000-00011.

    PMID: 3302292RESULT

  • Sahn SA. Management of complicated parapneumonic effusions. Am Rev Respir Dis. 1993 Sep;148(3):813-17. doi: 10.1164/ajrccm/148.3.813. No abstract available.

    PMID: 8368654RESULT

  • Taryle DA, Potts DE, Sahn SA. The incidence and clinical correlates of parapneumonic effusions in pneumococcal pneumonia. Chest. 1978 Aug;74(2):170-3. doi: 10.1378/chest.74.2.170. No abstract available.

    PMID: 679746RESULT

  • Pothula V, Krellenstein DJ. Early aggressive surgical management of parapneumonic empyemas. Chest. 1994 Mar;105(3):832-6. doi: 10.1378/chest.105.3.832.

    PMID: 8131548RESULT

  • Saito T, Kobayashi H, Kitamura S. Ultrasonographic approach to diagnosing chest wall tumors. Chest. 1988 Dec;94(6):1271-5. doi: 10.1378/chest.94.6.1271.

    PMID: 3056662RESULT

  • Lichtenstein DA. BLUE-protocol and FALLS-protocol: two applications of lung ultrasound in the critically ill. Chest. 2015 Jun;147(6):1659-1670. doi: 10.1378/chest.14-1313.

    PMID: 26033127RESULT

  • Lichtenstein DA, Menu Y. A bedside ultrasound sign ruling out pneumothorax in the critically ill. Lung sliding. Chest. 1995 Nov;108(5):1345-8. doi: 10.1378/chest.108.5.1345.

    PMID: 7587439RESULT

MeSH Terms

Conditions

Community-Acquired Infections

Condition Hierarchy (Ancestors)

Infections

Study Officials

  • DOUADI Dr Youcef, ch

    CH SAINT-QUENTIN

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2020

First Posted

April 16, 2020

Study Start

May 4, 2016

Primary Completion

May 4, 2020

Study Completion

May 4, 2020

Last Updated

July 14, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

the data will be collected on an electronic Ecrf, a single extraction is planned by the protocol, all the collected data will be analyzed centrally by the study cordernator,no data sharing is planned in the study

Locations

FR(4)