<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04477980</url>
  </required_header>
  <id_info>
    <org_study_id>CREC 2018.194</org_study_id>
    <nct_id>NCT04477980</nct_id>
  </id_info>
  <brief_title>Retrospective Review on Patients With Culture Negative Empyema</brief_title>
  <official_title>Retrospective Review on Patients With Culture Negative Empyema</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese University of Hong Kong</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Empyema is associated with a wide range of complication and mortality. It is defined by&#xD;
      either a positive pleural fluid culture or grossly pus appearance. However, little is known&#xD;
      about the differences in aetiology and outcome between culture-positive empyema (CPE) and&#xD;
      culture-negative empyema (CNE). The aim of the current study is to look at the local&#xD;
      prevalence of CNE, and compare the clinical outcome between CPE and CNE.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pneumonia is a common disease and it ranked second as the leading cause of death in Hong Kong&#xD;
      in 2016. Among patients suffering from acute pneumonia, up to 57% of them would develop&#xD;
      parapneumonic effusion. Without proper treatment, parapneumonic effusion would progress into&#xD;
      empyema, which is a clinical emergency. Empyema leads to a longer length of hospital stay, a&#xD;
      higher rate of complication and mortality than uncomplicated parapneumonic effusion.&#xD;
&#xD;
      The mainstay of treatment for empyema is antibiotics and drainage. Therefore, identification&#xD;
      of causative microorganism is important in guiding the choice of antibiotics. The common&#xD;
      bacterial culprits, for community acquired and hospital acquired, were identified by various&#xD;
      local and international studies. However, the aetiological agents were still unknown in up to&#xD;
      40% of cases. In addition, the clinical outcomes between culture negative empyema (CNE) and&#xD;
      culture positive empyema (CPE) are largely unknown. Data from one Taiwanese study suggested&#xD;
      that patients with CPE had a higher in-hospital mortality than those with CNE. However, the&#xD;
      primary objective of this study was not putting on the importance of CNE. Therefore, data on&#xD;
      outcome of CNE patients remain largely uncertain, either worldwide and local population.&#xD;
&#xD;
      The aim of the current study is to look at the local prevalence of CNE, and compare the&#xD;
      clinical outcome between CPE and CNE. Through more understanding of CNE, the clinical&#xD;
      management of this patient group may be altered and a better patient outcome is anticipated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 3, 2018</start_date>
  <completion_date type="Actual">May 31, 2020</completion_date>
  <primary_completion_date type="Actual">February 29, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Compare the mortality rate within same admission between patients with culture-positive empyema (CPE) and culture-negative empyema (CNE)</measure>
    <time_frame>Within the same episode of hospitalization or 7 days, whichever longer</time_frame>
    <description>Compare the mortality rate within same admission between patients with culture-positive empyema (CPE) and culture-negative empyema (CNE)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Prevalence of negative pleural fluid culture in patients with empyema</measure>
    <time_frame>6 years</time_frame>
    <description>Prevalence of negative pleural fluid culture in patients with empyema</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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</measure>
    <time_frame>Within the same episode of hospitalization or 90 days, whichever longer</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Investigate the risk factors of failure to obtain culture results in patients with CNE</measure>
    <time_frame>Within the same episode of hospitalization or 7 days, whichever longer</time_frame>
    <description>Investigate the risk factors of failure to obtain culture results in patients with CNE</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">153</enrollment>
  <condition>Empyema, Pleural</condition>
  <arm_group>
    <arm_group_label>Culture positive empyema</arm_group_label>
    <description>Patients with empyema confirmed by a positive pleural fluid culture, irrespective of its gross fluid appearance</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Culture negative empyema</arm_group_label>
    <description>Patients with empyema confirmed by a gross pus appearance AND a negative pleural fluid culture</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Disease outcome (mortality)</intervention_name>
    <description>Mortality rate between the two groups</description>
    <arm_group_label>Culture negative empyema</arm_group_label>
    <arm_group_label>Culture positive empyema</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        A. By using the International Classification of Diseases, Tenth Revision, Clinical&#xD;
        Modification code 510.0 or 510.9, all primary hospital discharge diagnosis of empyema&#xD;
        during a 5 year period, between 1st January 2013 to 31st December 2018&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        i. All patients hospitalized for empyema, defined by the presence of purulent pleural fluid&#xD;
        or positive culture result from pleural fluid ii. Age greater than 18 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        i. Inappropriate diagnosis of empyema after evaluation ii. Tuberculous pleuritis, defined&#xD;
        by presence of Mycobacterium tuberculosis culture from pleural fluid or granulomatous&#xD;
        inflammation on pleural biopsy histology&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ka Pang Chan, MBChB</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chinese University of Hong Kong</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chinese University of Hong Kong</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <link>
    <url>https://www.chp.gov.hk/en/statistics/data/10/27/117.html</url>
    <description>assessed on 13th April 2018</description>
  </link>
  <reference>
    <citation>Light RW, Girard WM, Jenkinson SG, George RB. Parapneumonic effusions. Am J Med. 1980 Oct;69(4):507-12. doi: 10.1016/0002-9343(80)90460-x.</citation>
    <PMID>7424940</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>19131449</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>679746</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>26836918</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>26510382</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>8733515</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>11401897</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>17548905</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>16479377</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>18414163</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>10382237</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>24512757</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>July 15, 2020</last_update_submitted>
  <last_update_submitted_qc>July 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Ka Pang Chan</investigator_full_name>
    <investigator_title>Honorary Clinical Tutor</investigator_title>
  </responsible_party>
  <keyword>Culture positive empyema</keyword>
  <keyword>Culture negative empyema</keyword>
  <keyword>Parapneumonic effusion</keyword>
  <keyword>Pleural fluid</keyword>
  <keyword>Pneumonia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Empyema</mesh_term>
    <mesh_term>Empyema, Pleural</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>all IPD that underlie results in a publication</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Starting 6 months after publication</ipd_time_frame>
    <ipd_access_criteria>upon individual approach for metaanalysis or related study</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04477980
org study id: CREC 2018.194
nct id: NCT04477980
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Cohort
time perspective: Retrospective
measure: 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
description: Compare the mortality rate within same admission between patients with culture-positive empyema (CPE) and culture-negative empyema (CNE)
measure: Prevalence of negative pleural fluid culture in patients with empyema
time frame: 6 years
description: Prevalence of negative pleural fluid culture in patients with empyema
measure: 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
description: 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
measure: 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
description: Investigate the risk factors of failure to obtain culture results in patients with CNE
arm group label: Culture positive empyema
description: Patients with empyema confirmed by a positive pleural fluid culture, irrespective of its gross fluid appearance
arm group label: Culture negative empyema
description: Patients with empyema confirmed by a gross pus appearance AND a negative pleural fluid culture
intervention type: Other
intervention name: Disease outcome (mortality)
description: Mortality rate between the two groups
arm group label: Culture negative empyema
arm group label: Culture positive empyema
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ka Pang Chan, MBChB
role: Principal Investigator
affiliation: Chinese University of Hong Kong
facility: 
country: Hong Kong
url: https://www.chp.gov.hk/en/statistics/data/10/27/117.html
description: assessed on 13th April 2018
citation: Light RW, Girard WM, Jenkinson SG, George RB. Parapneumonic effusions. Am J Med. 1980 Oct;69(4):507-12. doi: 10.1016/0002-9343(80)90460-x.
PMID: 7424940
citation: 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
citation: 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
citation: 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
citation: 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
citation: 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
citation: 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
citation: 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
citation: 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
citation: 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
citation: 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
citation: 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
responsible party type: Principal Investigator
investigator affiliation: Chinese University of Hong Kong
investigator full name: Ka Pang Chan
investigator title: Honorary Clinical Tutor
mesh term: Empyema
mesh term: Empyema, Pleural
sharing ipd: Yes
ipd description: all IPD that underlie results in a publication
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: Starting 6 months after publication
ipd access criteria: upon individual approach for metaanalysis or related study