Retrospective Review on Patients With Culture Negative Empyema

NCT04477980 | Completed

• 1 other identifier: CREC 2018.194
• Study Type: observational
• Target: 153
• Locations: 1 country
• Sites: 1

Brief 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). The aim of the current study is to look at the local prevalence of CNE, and compare the clinical outcome between CPE and CNE.

Conditions

Empyema, Pleural

Keywords

Culture positive empyema; Culture negative empyema; Parapneumonic effusion; Pleural fluid; Pneumonia

Outcome Measures

Primary Outcomes (1)

• 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)

  Within the same episode of hospitalization or 7 days, whichever longer

Secondary Outcomes (3)

• Prevalence of negative pleural fluid culture in patients with empyema

  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

  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

  Within the same episode of hospitalization or 7 days, whichever longer

Study Arms (2)

Culture positive empyema

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

Other: Disease outcome (mortality)

Culture negative empyema

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

Other: Disease outcome (mortality)

Interventions

Disease outcome (mortality) OTHER

Mortality rate between the two groups

Culture negative empyema; Culture positive empyema

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

Related Publications (12)

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  PMID: 7424940 BACKGROUND

• 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.

  PMID: 19131449 BACKGROUND

• 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: 679746 BACKGROUND

• 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.

  PMID: 26836918 BACKGROUND

• 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.

  PMID: 26510382 BACKGROUND

• 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.

  PMID: 8733515 BACKGROUND

• 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.

  PMID: 11401897 BACKGROUND

• 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.

  PMID: 17548905 BACKGROUND

• 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.

  PMID: 16479377 BACKGROUND

• 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.

  PMID: 18414163 BACKGROUND

• 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.

  PMID: 10382237 BACKGROUND

• 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.

  PMID: 24512757 BACKGROUND

Related Links

• assessed on 13th April 2018

MeSH Terms

Conditions

Empyema, Pleural; Pneumonia

Interventions

Mortality

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Empyema; Suppuration; Pleural Diseases; Respiratory Tract Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases

Intervention Hierarchy (Ancestors)

Vital Statistics; Data Collection; Epidemiologic Methods; Investigative Techniques; Demography; Population Characteristics; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Ka Pang Chan, MBChB

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Honorary Clinical Tutor

Study Record Dates

• First Submitted: June 28, 2020
• First Posted: July 20, 2020
• Study Start: May 3, 2018
• Primary Completion: February 29, 2020
• Study Completion: May 31, 2020
• Last Updated: July 20, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Starting 6 months after publication
• Access Criteria: upon individual approach for metaanalysis or related study

Locations

HK (1)