Retrospective Review on Patients With Culture Negative Empyema

Completed

• Conditions: Empyema, Pleural
• Interventions: Other: Disease outcome (mortality)

• Registration Number: NCT04477980
• Lead Sponsor: Chinese University of Hong Kong

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.

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 Timeline

• Study Start: 2018-05-03
• Primary Completion: 2020-02-29
• Study Completion: 2020-05-31
• Study First Submitted: 2020-06-28
• Status Verified: 2020-07
• Study First Submitted QC: 2020-07-15
• Last Update Submitted: 2020-07-15
• Study First Posted: 2020-07-20
• Last Update Posted: 2020-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 153

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Culture negative empyema	Disease outcome (mortality)	Patients with empyema confirmed by a gross pus appearance AND a negative pleural fluid culture
Culture positive empyema	Disease outcome (mortality)	Patients with empyema confirmed by a positive pleural fluid culture, irrespective of its gross fluid appearance

Primary Outcome Measures

Name	Time	Method
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	Compare the mortality rate within same admission between patients with culture-positive empyema (CPE) and culture-negative empyema (CNE)

Secondary Outcome Measures

Name	Time	Method
Prevalence of negative pleural fluid culture in patients with empyema	6 years	Prevalence of negative pleural fluid culture in patients with empyema
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	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
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	Investigate the risk factors of failure to obtain culture results in patients with CNE

Trial Locations

Locations (1)

Chinese University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong