Healthcare Associated PneumoniaNCT01966796
Clinical Characteristics and Microbiology of Healthcare Associated Pneumonia
An observational study of Healthcare Associated Pneumonia, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
Background The prediction of multi-drug resistant (MDR) pathogens is a key issue in the management of health-care associated pneumonia (HCAP). Multiple risk factors have been proposed, some of which overlap with items of the pneumonia severity index (PSI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Healthcare Associated Pneumonia
- How many people
- 530 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2013to Oct 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who were admitted to the Far Eastern Memorial Hospital, an 800-bed tertiary care hospital in northern Taiwan, from January 2005 to December 2010 were screened by discharge diagnoses.The patients whose primary discharge diagnosis was pneumonia (International Classification of Diseases codes 482, 485, and 486) were selected.
Who may be able to join
- patients who had been hospitalized in an acute care hospital for two or more days within the past 90 days;
- residents of a nursing home or long-term care facility;
- recipients of recent intravenous antibiotic therapy, chemotherapy or wound care within the past 30 days;
- or patients who attended a hospital or hemodialysis clinic.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Background The prediction of multi-drug resistant (MDR) pathogens is a key issue in the management of health-care associated pneumonia (HCAP). Multiple risk factors have been proposed, some of which overlap with items of the pneumonia severity index (PSI). The aim of this study was to investigate the relationship between PSI and presence of MDR pathogens.
Methods Patients who were admitted to a tertiary-care hospital from January 2005 to December 2010 were screened by a discharge diagnosis of pneumonia. Patients were enrolled if they fulfilled the definition of HCAP by 2005 ATS/IDSA guideline.
Read the detailed description
MDR bacteria were defined as Pseudomonas aeruginosa (P. aeruginosa), Enterobacter species, those not sensitive to second and third generation cephalosporins, Acinetobacter species, extended-spectrum β-lactamase (ESBL) Enterobacteriaceae such as Escherichia coli (E. coli) and Klebsiella pneumoniae (K. pneumoniae), Burkholderia cepacia (B. cepacia), Stenotrophomonas maltophilia (S. maltophilia), and methicillin resistant Staphylococcus aureus (MRSA).
The criteria for HCAP is defined as follows: patients who had been hospitalized in an acute care hospital for two or more days within the past 90 days; residents of a nursing home or long-term care facility; recipients of recent intravenous antibiotic therapy, chemotherapy or wound care within the past 30 days; or patients who attended a hospital or hemodialysis clinic.
- Conditions
- Healthcare Associated Pneumonia
- Keywords
- healthcare associated pneumonia, drug-resistant bacteria, pneumonia severity index
- Medical subject headings
- Healthcare-Associated Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PSI II | PSI less than 70 or equal to 70 | |
| PSI III | PSI 70-90 | |
| PSI IV | PSI 90-130 | |
| PSI V | PSI more than 130 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathogens of Healthcare Associated Pneumonia, Measured by the Number of Participants
sputum culture and sterile specimen such as blood or pleural effusion culture for healthcare associated pneumonia within seven days of admission
Measured: 7 days
Number of Participants With MDR Pathogens
MDR bacteria were defined as Pseudomonas aeruginosa (P. aeruginosa), Enterobacter species, those not sensitive to second and third generation cephalosporins, Acinetobacter species, extended-spectrum β-lactamase (ESBL) Enterobacteriaceae such as Escherichia coli (E. coli) and Klebsiella pneumoniae (K. pneumoniae), Burkholderia cepacia (B. cepacia), Stenotrophomonas maltophilia (S. maltophilia), and methicillin resistant Staphylococcus aureus (MRSA).
Measured: seven days after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2013 (estimated)
- Study startFeb 2013
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Healthcare Associated PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 530 participants (actual)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ping-Huai Wang, Far Eastern Memorial Hospital
- Investigators
- Ping-huai Wang, M.D., Principal investigator, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01966796
- Sponsor's protocol ID
- 102013-E
- Status last verified
- Sep 2020
- First submitted
- 12 Oct 2013
- Last updated
- 9 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Bartlett JG, Dowell SF, Mandell LA, File TM Jr, Musher DM, Fine MJ. Practice guidelines for the management of community-acquired pneumonia in adults. Infectious Diseases Society of America. Clin Infect Dis. 2000 Aug;31(2):347-82. doi: 10.1086/313954. Epub 2000 Sep 7. No abstract available.
PubMed 10987697Hospital-acquired pneumonia in adults: diagnosis, assessment of severity, initial antimicrobial therapy, and preventive strategies. A consensus statement, American Thoracic Society, November 1995. Am J Respir Crit Care Med. 1996 May;153(5):1711-25. doi: 10.1164/ajrccm.153.5.8630626. No abstract available.
PubMed 8630626American Thoracic Society; Infectious Diseases Society of America. Guidelines for the management of adults with hospital-acquired, ventilator-associated, and healthcare-associated pneumonia. Am J Respir Crit Care Med. 2005 Feb 15;171(4):388-416. doi: 10.1164/rccm.200405-644ST. No abstract available.
PubMed 15699079Micek ST, Reichley RM, Kollef MH. Health care-associated pneumonia (HCAP): empiric antibiotics targeting methicillin-resistant Staphylococcus aureus (MRSA) and Pseudomonas aeruginosa predict optimal outcome. Medicine (Baltimore). 2011 Nov;90(6):390-395. doi: 10.1097/MD.0b013e318239cf0a.
PubMed 22033455Song JH, Oh WS, Kang CI, Chung DR, Peck KR, Ko KS, Yeom JS, Kim CK, Kim SW, Chang HH, Kim YS, Jung SI, Tong Z, Wang Q, Huang SG, Liu JW, Lalitha MK, Tan BH, Van PH, Carlos CC, So T; Asian Network for Surveillance of Resistant Pathogens Study Group. Epidemiology and clinical outcomes of community-acquired pneumonia in adult patients in Asian countries: a prospective study by the Asian network for surveillance of resistant pathogens. Int J Antimicrob Agents. 2008 Feb;31(2):107-14. doi: 10.1016/j.ijantimicag.2007.09.014. Epub 2007 Dec 26.
PubMed 18162378
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Characteristics and Microbiology of Healthcare Associated Pneumonia
- ClinicalTrials.gov ID
- NCT01966796
- Acronym / sponsor ID
- 102013-E
- Conditions
- Healthcare Associated Pneumonia
- Keywords
- healthcare associated pneumonia, drug-resistant bacteria, pneumonia severity index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 530 participants (actual)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 22 Oct 2013 (estimated)
- Results
- Posted 9 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background The prediction of multi-drug resistant (MDR) pathogens is a key issue in the management of health-care associated pneumonia (HCAP). Multiple risk factors have been proposed, some of which overlap with items of the pneumonia severity index (PSI). The aim of this study was to investigate the relationship between PSI and presence of MDR pathogens.
Methods Patients who were admitted to a tertiary-care hospital from January 2005 to December 2010 were screened by a discharge diagnosis of pneumonia. Patients were enrolled if they fulfilled the definition of HCAP by 2005 ATS/IDSA guideline.
Detailed description
MDR bacteria were defined as Pseudomonas aeruginosa (P. aeruginosa), Enterobacter species, those not sensitive to second and third generation cephalosporins, Acinetobacter species, extended-spectrum β-lactamase (ESBL) Enterobacteriaceae such as Escherichia coli (E. coli) and Klebsiella pneumoniae (K. pneumoniae), Burkholderia cepacia (B. cepacia), Stenotrophomonas maltophilia (S. maltophilia), and methicillin resistant Staphylococcus aureus (MRSA).
The criteria for HCAP is defined as follows: patients who had been hospitalized in an acute care hospital for two or more days within the past 90 days; residents of a nursing home or long-term care facility; recipients of recent intravenous antibiotic therapy, chemotherapy or wound care within the past 30 days; or patients who attended a hospital or hemodialysis clinic.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PSI II | – | –PSI less than 70 or equal to 70 |
| PSI III | – | –PSI 70-90 |
| PSI IV | – | –PSI 90-130 |
| PSI V | – | –PSI more than 130 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who were admitted to the Far Eastern Memorial Hospital, an 800-bed tertiary care hospital in northern Taiwan, from January 2005 to December 2010 were screened by discharge diagnoses.The patients whose primary discharge diagnosis was pneumonia (International Classification of Diseases codes 482, 485, and 486) were selected.
Key inclusion criteria (4 listed)
- patients who had been hospitalized in an acute care hospital for two or more days within the past 90 days;
- residents of a nursing home or long-term care facility;
- recipients of recent intravenous antibiotic therapy, chemotherapy or wound care within the past 30 days;
- or patients who attended a hospital or hemodialysis clinic.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pathogens of Healthcare Associated Pneumonia, Measured by the Number of Participants
Time frame: 7 days
sputum culture and sterile specimen such as blood or pleural effusion culture for healthcare associated pneumonia within seven days of admission
Number of Participants With MDR Pathogens
Time frame: seven days after admission
MDR bacteria were defined as Pseudomonas aeruginosa (P. aeruginosa), Enterobacter species, those not sensitive to second and third generation cephalosporins, Acinetobacter species, extended-spectrum β-lactamase (ESBL) Enterobacteriaceae such as Escherichia coli (E. coli) and Klebsiella pneumoniae (K. pneumoniae), Burkholderia cepacia (B. cepacia), Stenotrophomonas maltophilia (S. maltophilia), and methicillin resistant Staphylococcus aureus (MRSA).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 10987697Bartlett JG, Dowell SF, Mandell LA, File TM Jr, Musher DM, Fine MJ. Practice guidelines for the management of community-acquired pneumonia in adults. Infectious Diseases Society of America. Clin Infect Dis. 2000 Aug;31(2):347-82. doi: 10.1086/313954. Epub 2000 Sep 7. No abstract available.
- Background: PubMed 8630626Hospital-acquired pneumonia in adults: diagnosis, assessment of severity, initial antimicrobial therapy, and preventive strategies. A consensus statement, American Thoracic Society, November 1995. Am J Respir Crit Care Med. 1996 May;153(5):1711-25. doi: 10.1164/ajrccm.153.5.8630626. No abstract available.
- Background: PubMed 15699079American Thoracic Society; Infectious Diseases Society of America. Guidelines for the management of adults with hospital-acquired, ventilator-associated, and healthcare-associated pneumonia. Am J Respir Crit Care Med. 2005 Feb 15;171(4):388-416. doi: 10.1164/rccm.200405-644ST. No abstract available.
- Background: PubMed 22033455Micek ST, Reichley RM, Kollef MH. Health care-associated pneumonia (HCAP): empiric antibiotics targeting methicillin-resistant Staphylococcus aureus (MRSA) and Pseudomonas aeruginosa predict optimal outcome. Medicine (Baltimore). 2011 Nov;90(6):390-395. doi: 10.1097/MD.0b013e318239cf0a.
- Background: PubMed 18162378Song JH, Oh WS, Kang CI, Chung DR, Peck KR, Ko KS, Yeom JS, Kim CK, Kim SW, Chang HH, Kim YS, Jung SI, Tong Z, Wang Q, Huang SG, Liu JW, Lalitha MK, Tan BH, Van PH, Carlos CC, So T; Asian Network for Surveillance of Resistant Pathogens Study Group. Epidemiology and clinical outcomes of community-acquired pneumonia in adult patients in Asian countries: a prospective study by the Asian network for surveillance of resistant pathogens. Int J Antimicrob Agents. 2008 Feb;31(2):107-14. doi: 10.1016/j.ijantimicag.2007.09.014. Epub 2007 Dec 26.
Related trials for Healthcare Associated Pneumonia
Not yet recruitingObservational study
Traditional Chinese Medicine in Multidrug-Resistant Bacterial Pneumonia
Multi Drug Resistant Infections, Pneumnia
Not yet recruitingObservational study
Early Identification of Pathogens in Children With Respiratory Tract Infection by Mechanical Ventilation Using mNGS
VAP - Ventilator Associated Pneumonia
RecruitingPhase 4
EaRly impAct theraPy With Ceftazidime-avibactam Via rapID Diagnostics
Blood Stream Infections, Ventilator Associated Pneumonia
Not yet recruiting
Mobile-Based Microlearning for Improving ICU Nurses' Adherence to Ventilator-Associated Pneumonia Prevention Protocols
Ventilator-Associated Pneumonia
Recruiting
Immediate Versus Substantiated Antibiotic Therapy in Suspected Non-Severe Ventilator-Associated Pneumonia
Ventilator-Associated Pneumonia (VAP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ping-huai Wang, M.D. principal investigator
Far Eastern Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthcare Associated Pneumonia, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathogens of Healthcare Associated Pneumonia, Measured by the Number of Participants (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01966796, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2020.