Community-Acquired InfectionsECHOPPNCT04348734
Management of Parapneumonic Pleurisy Guided by an Early Pleural Ultrasound
An observational study of Community-Acquired Infections, run by Central Hospital Saint Quentin at 4 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Community-Acquired Infections
- What is being tested?
- pleural ultrasound
- How many people
- 115 participants
- Where
- 4 sitesFrance
- Study dates
- 4 May 2016to 4 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: patients hospitalized for pneumonia
Who may be able to join
- adult patients, hospitalized for pneumonia or confirmed pleurisy, by imaging and exploratory pleural puncture.
- Patients affiliated to social security
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
France4 sites
Chu Amiens
Amiens, 80000
CH Pontoise
Cergy-Pontoise
CH Creteil
Créteil
Saint-Quentin Hospital
Saint-Quentin, 02100
About this study
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.
Read the 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
- Conditions
- Community-Acquired Infections
- Being tested
- pleural ultrasound
- Medical subject headings
- Community-Acquired Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (2)
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
Measured: 3 months
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start4 May 2016
- Primary completion4 May 2020
- Study completion4 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Community-Acquired InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital Saint Quentin
- Sponsor type
- Other government
- Collaborators
- Amiens University Hospital
- Responsible party
- Sponsor
- Investigators
- DOUADI Dr Youcef, ch, Principal investigator, CH SAINT-QUENTIN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04348734
- Sponsor's protocol ID
- 2015-A00993-46
- Acronym
- ECHOPP
- Status last verified
- Mar 2020
- First submitted
- 30 Mar 2020
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Publications
Light RW. Pleural diseases. Curr Opin Pulm Med. 2003 Jul;9(4):251-3. doi: 10.1097/00063198-200307000-00001. No abstract available.
PubMed 12806235Miserocchi G. Physiology and pathophysiology of pleural fluid turnover. Eur Respir J. 1997 Jan;10(1):219-25. doi: 10.1183/09031936.97.10010219.
PubMed 9032518Davies 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.
PubMed 12728147Hamm H, Light RW. Parapneumonic effusion and empyema. Eur Respir J. 1997 May;10(5):1150-6. doi: 10.1183/09031936.97.10051150.
PubMed 9163661LeMense 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.
PubMed 7781342Bober 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.
PubMed 17006405Soldati G, Sher S. Bedside lung ultrasound in critical care practice. Minerva Anestesiol. 2009 Sep;75(9):509-17.
PubMed 19644435Ramnath 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.
PubMed 9417153Xirouchaki 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.
PubMed 21809107Tokuda 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.
PubMed 16537882Stavas 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.
PubMed 3302292Sahn 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.
PubMed 8368654Taryle 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.
PubMed 679746Pothula V, Krellenstein DJ. Early aggressive surgical management of parapneumonic empyemas. Chest. 1994 Mar;105(3):832-6. doi: 10.1378/chest.105.3.832.
PubMed 8131548Saito 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.
PubMed 3056662
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Parapneumonic Pleurisy Guided by an Early Pleural Ultrasound
- ClinicalTrials.gov ID
- NCT04348734
- Acronym / sponsor ID
- ECHOPP / 2015-A00993-46
- Conditions
- Community-Acquired Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Central Hospital Saint QuentinOther government
- Collaborators
- Amiens University Hospital
- Study start
- 4 May 2016 (actual)
- Primary completion
- 4 May 2020 (actual)
- Study completion
- 4 May 2020 (actual)
- First posted
- 16 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients hospitalized for pneumonia
Key inclusion criteria (2 listed)
- adult patients, hospitalized for pneumonia or confirmed pleurisy, by imaging and exploratory pleural puncture.
- Patients affiliated to social security
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pleural ultrasoundPatients 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 | Diagnostic test | – |
Primary outcome
interet de l'échographie pleurale dans les pleurésies parapneumoniques
Time frame: 1 year
Evaluate the failure of medical treatment, defined as the need to resort to surgery, or death secondary to pleuris
2 secondary outcomes
presence radiological sequelae a pleural effusion at 3 months
Time frame: 3 months
presence radiological sequelae a pleural effusion at 6 months
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
- Results publication: PubMed 12806235Light RW. Pleural diseases. Curr Opin Pulm Med. 2003 Jul;9(4):251-3. doi: 10.1097/00063198-200307000-00001. No abstract available.
- Results publication: PubMed 9032518Miserocchi G. Physiology and pathophysiology of pleural fluid turnover. Eur Respir J. 1997 Jan;10(1):219-25. doi: 10.1183/09031936.97.10010219.
- Results publication: PubMed 12728147Davies 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.
- Results publication: PubMed 9163661Hamm H, Light RW. Parapneumonic effusion and empyema. Eur Respir J. 1997 May;10(5):1150-6. doi: 10.1183/09031936.97.10051150.
- Results publication: PubMed 7781342LeMense 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.
- Results publication: PubMed 17006405Bober 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.
- Results publication: PubMed 19644435Soldati G, Sher S. Bedside lung ultrasound in critical care practice. Minerva Anestesiol. 2009 Sep;75(9):509-17.
- Results publication: PubMed 9417153Ramnath 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.
- Results publication: PubMed 21809107Xirouchaki 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.
- Results publication: PubMed 16537882Tokuda 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.
- Results publication: PubMed 3302292Stavas 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.
- Results publication: PubMed 8368654Sahn 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.
- Individual participant dataSharing planned: No. 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
Related trials for Community-Acquired Infections
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection
RecruitingObservational study
Cardiovascular Disease Progression in Survivors of Community Acquired Pneumonia and Lung Infection by Covid-19.
Pneumonia, Community-Acquired, COVID-19 Pneumonia
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
Not yet recruitingPhase 4
Ceftriaxone Dosage for Non-Critical Community-Acquired Pneumonia
Community Acquired Pneumonia (CAP)
Active, not recruitingPhase 2/3
Inhaled Lexofloxacin vs Usual Care for Treatment of Community-Acquired Pneumonia
Community-acquired Pneumonia, CAP
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
DOUADI Dr Youcef, ch principal investigator
CH SAINT-QUENTIN
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Community-Acquired Infections, run by Central Hospital Saint Quentin at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
interet de l'échographie pleurale dans les pleurésies parapneumoniques (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04348734, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2020.