Empyema, PleuralNCT04477980
Retrospective Review on Patients With Culture Negative Empyema
An observational study of Empyema, Pleural, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Empyema is associated with a wide range of complication and mortality. It is defined by either a positive pleural fluid culture or grossly pus appearance. However, little is known about the differences in aetiology and outcome between culture-positive empyema (CPE) and culture-negative empyema (CNE). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Empyema, Pleural
- What is being tested?
- Disease outcome (mortality)
- How many people
- 153 participants
- Where
- 1 siteHong Kong
- Study dates
- 3 May 2018to 31 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
- No healthy volunteers
- Adult, Older adult
Study population: A. By using the International Classification of Diseases, Tenth Revision, Clinical Modification code 510.0 or 510.9, all primary hospital discharge diagnosis of empyema during a 5 year period, between 1st January 2013 to 31st December 2018
Who may be able to join
- All patients hospitalized for empyema, defined by the presence of purulent pleural fluid or positive culture result from pleural fluid ii. Age greater than 18 years old
Who cannot join
- Inappropriate diagnosis of empyema after evaluation ii. Tuberculous pleuritis, defined by presence of Mycobacterium tuberculosis culture from pleural fluid or granulomatous inflammation on pleural biopsy histology
Trial locations and contacts
1 site in 1 country.
About this study
Empyema is associated with a wide range of complication and mortality. It is defined by either a positive pleural fluid culture or grossly pus appearance. However, little is known about the differences in aetiology and outcome between culture-positive empyema (CPE) and culture-negative empyema (CNE). The aim of the current study is to look at the local prevalence of CNE, and compare the clinical outcome between CPE and CNE.
Read the detailed description
Pneumonia is a common disease and it ranked second as the leading cause of death in Hong Kong in 2016. Among patients suffering from acute pneumonia, up to 57% of them would develop parapneumonic effusion. Without proper treatment, parapneumonic effusion would progress into empyema, which is a clinical emergency. Empyema leads to a longer length of hospital stay, a higher rate of complication and mortality than uncomplicated parapneumonic effusion.
The mainstay of treatment for empyema is antibiotics and drainage. Therefore, identification of causative microorganism is important in guiding the choice of antibiotics. The common bacterial culprits, for community acquired and hospital acquired, were identified by various local and international studies. However, the aetiological agents were still unknown in up to 40% of cases. In addition, the clinical outcomes between culture negative empyema (CNE) and culture positive empyema (CPE) are largely unknown. Data from one Taiwanese study suggested that patients with CPE had a higher in-hospital mortality than those with CNE. However, the primary objective of this study was not putting on the importance of CNE. Therefore, data on outcome of CNE patients remain largely uncertain, either worldwide and local population.
The aim of the current study is to look at the local prevalence of CNE, and compare the clinical outcome between CPE and CNE. Through more understanding of CNE, the clinical management of this patient group may be altered and a better patient outcome is anticipated.
- Conditions
- Empyema, Pleural
- Being tested
- Disease outcome (mortality)
- Keywords
- Culture positive empyema, Culture negative empyema, Parapneumonic effusion, Pleural fluid, Pneumonia
- Medical subject headings
- Empyema, Pleural, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disease outcome (mortality)Other
Mortality rate between the two groups
| Study group | Role | What they receive |
|---|---|---|
| Culture positive empyema | Patients with empyema confirmed by a positive pleural fluid culture, irrespective of its gross fluid appearance Receives: Other: Disease outcome (mortality) | |
| Culture negative empyema | Patients with empyema confirmed by a gross pus appearance AND a negative pleural fluid culture Receives: Other: Disease outcome (mortality) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the mortality rate within same admission between patients with culture-positive empyema (CPE) and culture-negative empyema (CNE)
Compare the mortality rate within same admission between patients with culture-positive empyema (CPE) and culture-negative empyema (CNE)
Measured: Within the same episode of hospitalization or 7 days, whichever longer
Secondary outcomes (3)
Prevalence of negative pleural fluid culture in patients with empyema
Prevalence of negative pleural fluid culture in patients with empyema
Measured: 6 years
b. Compare other clinical outcomes (length of hospital stay, duration of intravenous antibiotics, number of pleural drainage received, need of surgical treatment, 30-days and 90-days mortality) between patients with CNE and CPE
Compare other clinical outcomes (length of hospital stay, duration of intravenous antibiotics, number of pleural drainage received, need of surgical treatment, 30-days and 90-days mortality) between patients with CNE and CPE
Measured: Within the same episode of hospitalization or 90 days, whichever longer
Investigate the risk factors of failure to obtain culture results in patients with CNE
Investigate the risk factors of failure to obtain culture results in patients with CNE
Measured: Within the same episode of hospitalization or 7 days, whichever longer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start3 May 2018
- Primary completion29 Feb 2020
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Empyema, PleuralStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ka Pang Chan, Chinese University of Hong Kong
- Investigators
- Ka Pang Chan, MBChB, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04477980
- Sponsor's protocol ID
- CREC 2018.194
- Status last verified
- Jul 2020
- First submitted
- 28 Jun 2020
- Last updated
- 20 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Publications
Light RW, Girard WM, Jenkinson SG, George RB. Parapneumonic effusions. Am J Med. 1980 Oct;69(4):507-12. doi: 10.1016/0002-9343(80)90460-x.
PubMed 7424940Chalmers JD, Singanayagam A, Murray MP, Scally C, Fawzi A, Hill AT. Risk factors for complicated parapneumonic effusion and empyema on presentation to hospital with community-acquired pneumonia. Thorax. 2009 Jul;64(7):592-7. doi: 10.1136/thx.2008.105080. Epub 2009 Jan 8.
PubMed 19131449Taryle 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 679746Dean NC, Griffith PP, Sorensen JS, McCauley L, Jones BE, Lee YC. Pleural Effusions at First ED Encounter Predict Worse Clinical Outcomes in Patients With Pneumonia. Chest. 2016 Jun;149(6):1509-15. doi: 10.1016/j.chest.2015.12.027. Epub 2016 Jan 16.
PubMed 26836918Kim J, Park JS, Cho YJ, Yoon HI, Lee JH, Lee CT, Lim HJ, Kim DK. Predictors of prolonged stay in patients with community-acquired pneumonia and complicated parapneumonic effusion. Respirology. 2016 Jan;21(1):164-71. doi: 10.1111/resp.12658. Epub 2015 Oct 29.
PubMed 26510382Ferguson AD, Prescott RJ, Selkon JB, Watson D, Swinburn CR. The clinical course and management of thoracic empyema. QJM. 1996 Apr;89(4):285-9. doi: 10.1093/qjmed/89.4.285.
PubMed 8733515Niederman MS, Mandell LA, Anzueto A, Bass JB, Broughton WA, Campbell GD, Dean N, File T, Fine MJ, Gross PA, Martinez F, Marrie TJ, Plouffe JF, Ramirez J, Sarosi GA, Torres A, Wilson R, Yu VL; American Thoracic Society. Guidelines for the management of adults with community-acquired pneumonia. Diagnosis, assessment of severity, antimicrobial therapy, and prevention. Am J Respir Crit Care Med. 2001 Jun;163(7):1730-54. doi: 10.1164/ajrccm.163.7.at1010. No abstract available.
PubMed 11401897Tsang KY, Leung WS, Chan VL, Lin AW, Chu CM. Complicated parapneumonic effusion and empyema thoracis: microbiology and predictors of adverse outcomes. Hong Kong Med J. 2007 Jun;13(3):178-86.
PubMed 17548905Tu CY, Hsu WH, Hsia TC, Chen HJ, Chiu KL, Hang LW, Shih CM. The changing pathogens of complicated parapneumonic effusions or empyemas in a medical intensive care unit. Intensive Care Med. 2006 Apr;32(4):570-6. doi: 10.1007/s00134-005-0064-7. Epub 2006 Feb 15.
PubMed 16479377Lin YC, Chen HJ, Liu YH, Shih CM, Hsu WH, Tu CY. A 30-month experience of thoracic empyema in a tertiary hospital: emphasis on differing bacteriology and outcome between the medical intensive care unit (MICU) and medical ward. South Med J. 2008 May;101(5):484-9. doi: 10.1097/SMJ.0b013e31816c00fa.
PubMed 18414163Lindstrom ST, Kolbe J. Community acquired parapneumonic thoracic empyema: predictors of outcome. Respirology. 1999 Jun;4(2):173-9. doi: 10.1046/j.1440-1843.1999.00170.x.
PubMed 10382237Chen KC, Chen HY, Lin JW, Tseng YT, Kuo SW, Huang PM, Hsu HH, Lee JM, Chen JS, Lai HS. Acute thoracic empyema: clinical characteristics and outcome analysis of video-assisted thoracoscopic surgery. J Formos Med Assoc. 2014 Apr;113(4):210-8. doi: 10.1016/j.jfma.2013.12.010. Epub 2014 Feb 7.
PubMed 24512757
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Review on Patients With Culture Negative Empyema
- ClinicalTrials.gov ID
- NCT04477980
- Acronym / sponsor ID
- CREC 2018.194
- Conditions
- Empyema, Pleural
- Keywords
- Culture positive empyema, Culture negative empyema, Parapneumonic effusion, Pleural fluid, Pneumonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 3 May 2018 (actual)
- Primary completion
- 29 Feb 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 20 Jul 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.
Empyema is associated with a wide range of complication and mortality. It is defined by either a positive pleural fluid culture or grossly pus appearance. However, little is known about the differences in aetiology and outcome between culture-positive empyema (CPE) and culture-negative empyema (CNE). The aim of the current study is to look at the local prevalence of CNE, and compare the clinical outcome between CPE and CNE.
Detailed description
Pneumonia is a common disease and it ranked second as the leading cause of death in Hong Kong in 2016. Among patients suffering from acute pneumonia, up to 57% of them would develop parapneumonic effusion. Without proper treatment, parapneumonic effusion would progress into empyema, which is a clinical emergency. Empyema leads to a longer length of hospital stay, a higher rate of complication and mortality than uncomplicated parapneumonic effusion.
The mainstay of treatment for empyema is antibiotics and drainage. Therefore, identification of causative microorganism is important in guiding the choice of antibiotics. The common bacterial culprits, for community acquired and hospital acquired, were identified by various local and international studies. However, the aetiological agents were still unknown in up to 40% of cases. In addition, the clinical outcomes between culture negative empyema (CNE) and culture positive empyema (CPE) are largely unknown. Data from one Taiwanese study suggested that patients with CPE had a higher in-hospital mortality than those with CNE. However, the primary objective of this study was not putting on the importance of CNE. Therefore, data on outcome of CNE patients remain largely uncertain, either worldwide and local population.
The aim of the current study is to look at the local prevalence of CNE, and compare the clinical outcome between CPE and CNE. Through more understanding of CNE, the clinical management of this patient group may be altered and a better patient outcome is anticipated.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Culture positive empyema | – | Other: Disease outcome (mortality)Patients with empyema confirmed by a positive pleural fluid culture, irrespective of its gross fluid appearance |
| Culture negative empyema | – | Other: Disease outcome (mortality)Patients with empyema confirmed by a gross pus appearance AND a negative pleural fluid culture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A. By using the International Classification of Diseases, Tenth Revision, Clinical Modification code 510.0 or 510.9, all primary hospital discharge diagnosis of empyema during a 5 year period, between 1st January 2013 to 31st December 2018
Key inclusion criteria (1 listed)
- All patients hospitalized for empyema, defined by the presence of purulent pleural fluid or positive culture result from pleural fluid ii. Age greater than 18 years old
Key exclusion criteria (1 listed)
- Inappropriate diagnosis of empyema after evaluation ii. Tuberculous pleuritis, defined by presence of Mycobacterium tuberculosis culture from pleural fluid or granulomatous inflammation on pleural biopsy histology
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 |
|---|---|---|
| Disease outcome (mortality)Mortality rate between the two groups | Other | Culture negative empyema, Culture positive empyema |
Primary outcome
Compare the mortality rate within same admission between patients with culture-positive empyema (CPE) and culture-negative empyema (CNE)
Time frame: Within the same episode of hospitalization or 7 days, whichever longer
Compare the mortality rate within same admission between patients with culture-positive empyema (CPE) and culture-negative empyema (CNE)
3 secondary outcomes
Prevalence of negative pleural fluid culture in patients with empyema
Time frame: 6 years
b. Compare other clinical outcomes (length of hospital stay, duration of intravenous antibiotics, number of pleural drainage received, need of surgical treatment, 30-days and 90-days mortality) between patients with CNE and CPE
Time frame: Within the same episode of hospitalization or 90 days, whichever longer
Investigate the risk factors of failure to obtain culture results in patients with CNE
Time frame: Within the same episode of hospitalization or 7 days, whichever longer
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 20 Jul 2020.
- Background: PubMed 7424940Light RW, Girard WM, Jenkinson SG, George RB. Parapneumonic effusions. Am J Med. 1980 Oct;69(4):507-12. doi: 10.1016/0002-9343(80)90460-x.
- Background: PubMed 19131449Chalmers JD, Singanayagam A, Murray MP, Scally C, Fawzi A, Hill AT. Risk factors for complicated parapneumonic effusion and empyema on presentation to hospital with community-acquired pneumonia. Thorax. 2009 Jul;64(7):592-7. doi: 10.1136/thx.2008.105080. Epub 2009 Jan 8.
- Background: PubMed 679746Taryle 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.
- Background: PubMed 26836918Dean NC, Griffith PP, Sorensen JS, McCauley L, Jones BE, Lee YC. Pleural Effusions at First ED Encounter Predict Worse Clinical Outcomes in Patients With Pneumonia. Chest. 2016 Jun;149(6):1509-15. doi: 10.1016/j.chest.2015.12.027. Epub 2016 Jan 16.
- Background: PubMed 26510382Kim J, Park JS, Cho YJ, Yoon HI, Lee JH, Lee CT, Lim HJ, Kim DK. Predictors of prolonged stay in patients with community-acquired pneumonia and complicated parapneumonic effusion. Respirology. 2016 Jan;21(1):164-71. doi: 10.1111/resp.12658. Epub 2015 Oct 29.
- Background: PubMed 8733515Ferguson AD, Prescott RJ, Selkon JB, Watson D, Swinburn CR. The clinical course and management of thoracic empyema. QJM. 1996 Apr;89(4):285-9. doi: 10.1093/qjmed/89.4.285.
- Background: PubMed 11401897Niederman MS, Mandell LA, Anzueto A, Bass JB, Broughton WA, Campbell GD, Dean N, File T, Fine MJ, Gross PA, Martinez F, Marrie TJ, Plouffe JF, Ramirez J, Sarosi GA, Torres A, Wilson R, Yu VL; American Thoracic Society. Guidelines for the management of adults with community-acquired pneumonia. Diagnosis, assessment of severity, antimicrobial therapy, and prevention. Am J Respir Crit Care Med. 2001 Jun;163(7):1730-54. doi: 10.1164/ajrccm.163.7.at1010. No abstract available.
- Background: PubMed 17548905Tsang KY, Leung WS, Chan VL, Lin AW, Chu CM. Complicated parapneumonic effusion and empyema thoracis: microbiology and predictors of adverse outcomes. Hong Kong Med J. 2007 Jun;13(3):178-86.
- Background: PubMed 16479377Tu CY, Hsu WH, Hsia TC, Chen HJ, Chiu KL, Hang LW, Shih CM. The changing pathogens of complicated parapneumonic effusions or empyemas in a medical intensive care unit. Intensive Care Med. 2006 Apr;32(4):570-6. doi: 10.1007/s00134-005-0064-7. Epub 2006 Feb 15.
- Background: PubMed 18414163Lin YC, Chen HJ, Liu YH, Shih CM, Hsu WH, Tu CY. A 30-month experience of thoracic empyema in a tertiary hospital: emphasis on differing bacteriology and outcome between the medical intensive care unit (MICU) and medical ward. South Med J. 2008 May;101(5):484-9. doi: 10.1097/SMJ.0b013e31816c00fa.
- Background: PubMed 10382237Lindstrom ST, Kolbe J. Community acquired parapneumonic thoracic empyema: predictors of outcome. Respirology. 1999 Jun;4(2):173-9. doi: 10.1046/j.1440-1843.1999.00170.x.
- Background: PubMed 24512757Chen KC, Chen HY, Lin JW, Tseng YT, Kuo SW, Huang PM, Hsu HH, Lee JM, Chen JS, Lai HS. Acute thoracic empyema: clinical characteristics and outcome analysis of video-assisted thoracoscopic surgery. J Formos Med Assoc. 2014 Apr;113(4):210-8. doi: 10.1016/j.jfma.2013.12.010. Epub 2014 Feb 7.
- assessed on 13th April 2018Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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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.
Ka Pang Chan, MBChB principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Empyema, Pleural, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 1 inclusion and 1 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 20 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 1 site in Hong Kong. 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?
Compare the mortality rate within same admission between patients with culture-positive empyema (CPE) and culture-negative empyema (CNE) (time frame: Within the same episode of hospitalization or 7 days, whichever longer). 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 NCT04477980, which also lists 12 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 20 Jul 2020; AzTrials last refreshed its copy on 7 Nov 2026.