Retrospective Review on Patients With Culture Negative Empyema

July 15, 2020 updated by: Ka Pang Chan, Chinese University of Hong Kong
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

153

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Chinese University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Within the same episode of hospitalization or 7 days, whichever longer

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of negative pleural fluid culture in patients with empyema
Time Frame: 6 years
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
Time Frame: 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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 3, 2018

Primary Completion (Actual)

February 29, 2020

Study Completion (Actual)

May 31, 2020

Study Registration Dates

First Submitted

June 28, 2020

First Submitted That Met QC Criteria

July 15, 2020

First Posted (Actual)

July 20, 2020

Study Record Updates

Last Update Posted (Actual)

July 20, 2020

Last Update Submitted That Met QC Criteria

July 15, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CREC 2018.194

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

all IPD that underlie results in a publication

IPD Sharing Time Frame

Starting 6 months after publication

IPD Sharing Access Criteria

upon individual approach for metaanalysis or related study

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Empyema, Pleural

Clinical Trials on Disease outcome (mortality)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in El Salvador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe