Retrospective Review on Patients With Culture Negative Empyema

NCT ID: NCT04477980

Last Updated: 2020-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

153 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-03

Study Completion Date

2020-05-31

Brief Summary

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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

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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

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Empyema, Pleural

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Culture positive empyema

Patients with empyema confirmed by a positive pleural fluid culture, irrespective of its gross fluid appearance

Disease outcome (mortality)

Intervention Type OTHER

Mortality rate between the two groups

Culture negative empyema

Patients with empyema confirmed by a gross pus appearance AND a negative pleural fluid culture

Disease outcome (mortality)

Intervention Type OTHER

Mortality rate between the two groups

Interventions

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Disease outcome (mortality)

Mortality rate between the two groups

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

i. 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

Exclusion Criteria

i. 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Ka Pang Chan

Honorary Clinical Tutor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ka Pang Chan, MBChB

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

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Chinese University of Hong Kong

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

References

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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. doi: 10.1378/chest.74.2.170. No abstract available.

Reference Type BACKGROUND
PMID: 679746 (View on PubMed)

Dean 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.

Reference Type BACKGROUND
PMID: 26836918 (View on PubMed)

Kim 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.

Reference Type BACKGROUND
PMID: 26510382 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7424940 (View on PubMed)

Chalmers 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.

Reference Type BACKGROUND
PMID: 19131449 (View on PubMed)

Ferguson 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.

Reference Type BACKGROUND
PMID: 8733515 (View on PubMed)

Niederman 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.

Reference Type BACKGROUND
PMID: 11401897 (View on PubMed)

Tsang 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.

Reference Type BACKGROUND
PMID: 17548905 (View on PubMed)

Tu 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.

Reference Type BACKGROUND
PMID: 16479377 (View on PubMed)

Lin 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.

Reference Type BACKGROUND
PMID: 18414163 (View on PubMed)

Lindstrom 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.

Reference Type BACKGROUND
PMID: 10382237 (View on PubMed)

Chen 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.

Reference Type BACKGROUND
PMID: 24512757 (View on PubMed)

Related Links

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Other Identifiers

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CREC 2018.194

Identifier Type: -

Identifier Source: org_study_id

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