An observational study in Empyema, Pleural, sponsored by Chinese University of Hong Kong. Completed at 1 site in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-20.
Sponsored by Chinese University of Hong Kong · Observational
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.
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.
33 studies on the registry are indexed under Empyema, Pleural; 11 are open to participants now.
Browse Empyema, Pleural studies →Chinese University of Hong Kong is the lead sponsor of 1,454 studies on the registry; 474 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 histology
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with empyema confirmed by a positive pleural fluid culture, irrespective of its gross fluid appearance
Other: Disease outcome (mortality)
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
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)
Time frame: Within the same episode of hospitalization or 7 days, whichever longer
Prevalence of negative pleural fluid culture in patients with empyema
Prevalence of negative pleural fluid culture in patients with empyema
Time frame: 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
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
Investigate the risk factors of failure to obtain culture results in patients with CNE
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
Plan to share: Yes — all IPD that underlie results in a publication
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Starting 6 months after publication
Access criteria: upon individual approach for metaanalysis or related study
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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