Retrospective Review on Patients With Culture Negative Empyema

Sponsor
Chinese University of Hong Kong (Other)
Overall Status
Completed
CT.gov ID
NCT04477980
Collaborator
(none)
153
1
24.9
6.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Disease outcome (mortality)

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

Study Type:
Observational
Actual Enrollment :
153 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Retrospective Review on Patients With Culture Negative Empyema
Actual Study Start Date :
May 3, 2018
Actual Primary Completion Date :
Feb 29, 2020
Actual Study Completion Date :
May 31, 2020

Arms and Interventions

Arm Intervention/Treatment
Culture positive empyema

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

Other: Disease outcome (mortality)
Mortality rate between the two groups

Culture negative empyema

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

Other: Disease outcome (mortality)
Mortality rate between the two groups

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Prevalence of negative pleural fluid culture in patients with empyema [6 years]

    Prevalence of negative pleural fluid culture in patients with empyema

  2. 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

  3. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. 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:
  1. 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chinese University of Hong Kong Hong Kong Hong Kong

Sponsors and Collaborators

  • Chinese University of Hong Kong

Investigators

  • Principal Investigator: Ka Pang Chan, MBChB, Chinese University of Hong Kong

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Ka Pang Chan, Honorary Clinical Tutor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT04477980
Other Study ID Numbers:
  • CREC 2018.194
First Posted:
Jul 20, 2020
Last Update Posted:
Jul 20, 2020
Last Verified:
Jul 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ka Pang Chan, Honorary Clinical Tutor, Chinese University of Hong Kong
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 20, 2020