Ignite Creation Date:
2024-05-05 @ 9:24 PM
Last Modification Date:
2024-10-26 @ 10:03 AM
Study NCT ID:
NCT00873522
Status:
UNKNOWN
Last Update Posted:
2009-04-01
First Post:
2009-03-31
Brief Title:
Microbiology and Clinical Outcome of Pneumonia
Sponsor:
Taichung Veterans General Hospital
Organization:
Taichung Veterans General Hospital
Study Overview
Official Title:
Microbiology and Clinical Outcome of Community Acquired Pneumonia and Health-Care-Associated Pneumonia in Taiwan a Multi-Center Study
Status:
UNKNOWN
Status Verified Date:
2009-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
1 BACKGROUND
Pneumonia occurring outside of the hospital setting is regarded as community acquired pneumonia However pneumonia occurring in non-hospital long-term care facilities constituted a distinct type of pneumonia from CAP Kollef et al has justified health care associated pneumonia HCAP as a new category of pneumonia 1 The HCAP patients are associated with severe disease higher mortality rate and greater length of stay and increased cost 1 HCAP are often at risk for multi-drug resistant bacterial pathogens such as Pseudomonas aeruginosa extended-spectrum beta-lactamase Klebsiella pneumoniae Acinetobacter baumannii and methicillin-resistant S aureus MRSA 2
Health care facilities have not been defined in Taiwan Respiratory care ward RCW is a special unit to take care long-term ventilatory dependent patients in Taiwan Some of the patients get pneumonia and are referred back to medical centers Besides community-acquired P aeruginosa Acinetobacter baumannii or MRSA have been reported 3-8 Therefore the core-organisms of HCAP in Taiwan might be multi-drug resistant and the causes of inadequate initial antibiotics treatment The common pathogens were also unknown
Till now there are no data about the pathogens of HCAP in Taiwan We define the health-care facilities and initiate a retrospective study to characterize the microbiology and clinical outcome of Community acquired pneumonia and Health-Care-Associated pneumonia in Taiwan Further analysis will perform to confirm the differences between CAP an HCAP in Taiwan
2 Objectives
I To characterize CAP and HCAP i Microbiological epidemiology ii Disease severity PSI iii Outcome length of stay mortality antimicrobial susceptibility and treatment outcomes II To characterize HCAP from RCW i Microbiological epidemiology ii Disease severity PSI iii Outcome length of stay mortality
3 Study design
This is a retrospective multi-center cohort study to characterize microbiology and clinical outcomes in Taiwan
Data sources CAP or HCAP registered in 4 medical centers from Jan 1 2007 to Dec 31 2007 2 in north Taiwan 1 in central Taiwan 1 in south Taiwan Expected case number 800 HCAP and 1800 CAP
Pneumonia occurring outside of the hospital setting is regarded as community acquired pneumonia However pneumonia occurring in non-hospital long-term care facilities constituted a distinct type of pneumonia from CAP Kollef et al has justified health care associated pneumonia HCAP as a new category of pneumonia 1 The HCAP patients are associated with severe disease higher mortality rate and greater length of stay and increased cost 1 HCAP are often at risk for multi-drug resistant bacterial pathogens such as Pseudomonas aeruginosa extended-spectrum beta-lactamase Klebsiella pneumoniae Acinetobacter baumannii and methicillin-resistant S aureus MRSA 2
Health care facilities have not been defined in Taiwan Respiratory care ward RCW is a special unit to take care long-term ventilatory dependent patients in Taiwan Some of the patients get pneumonia and are referred back to medical centers Besides community-acquired P aeruginosa Acinetobacter baumannii or MRSA have been reported 3-8 Therefore the core-organisms of HCAP in Taiwan might be multi-drug resistant and the causes of inadequate initial antibiotics treatment The common pathogens were also unknown
Till now there are no data about the pathogens of HCAP in Taiwan We define the health-care facilities and initiate a retrospective study to characterize the microbiology and clinical outcome of Community acquired pneumonia and Health-Care-Associated pneumonia in Taiwan Further analysis will perform to confirm the differences between CAP an HCAP in Taiwan
2 Objectives
I To characterize CAP and HCAP i Microbiological epidemiology ii Disease severity PSI iii Outcome length of stay mortality antimicrobial susceptibility and treatment outcomes II To characterize HCAP from RCW i Microbiological epidemiology ii Disease severity PSI iii Outcome length of stay mortality
3 Study design
This is a retrospective multi-center cohort study to characterize microbiology and clinical outcomes in Taiwan
Data sources CAP or HCAP registered in 4 medical centers from Jan 1 2007 to Dec 31 2007 2 in north Taiwan 1 in central Taiwan 1 in south Taiwan Expected case number 800 HCAP and 1800 CAP
Detailed Description:
BACKGROUND
Pneumonia occurring outside of the hospital setting is regarded as community acquired pneumonia However pneumonia occurring in non-hospital long-term care facilities constituted a distinct type of pneumonia from CAP Kollef et al has justified health care associated pneumonia HCAP as a new category of pneumonia The HCAP patients are associated with severe disease higher mortality rate and greater length of stay and increased cost - HCAP are often at risk for multi-drug resistant bacterial pathogens such as Pseudomonas aeruginosa extended-spectrum beta-lactamase Klebsiella pneumoniae Acinetobacter baumannii and methicillin-resistant S aureus MRSA Health care facilities have not been defined in Taiwan Respiratory care ward RCW is a special unit to take care long-term ventilatory dependent patients in Taiwan Some of the patients get pneumonia and are referred back to medical centers Besides community-acquired P aeruginosa Acinetobacter baumannii or MRSA have been reported 3-8 Therefore the core-organisms of HCAP in Taiwan might be multi-drug resistant and the causes of inadequate initial antibiotics treatment The common pathogens were also unknown
Till now there are no data about the pathogens of HCAP in Taiwan We define the health-care facilities and initiate a retrospective study to characterize the microbiology and clinical outcome of Community acquired pneumonia and Health-Care-Associated pneumonia in Taiwan Further analysis will perform to confirm the differences between CAP an HCAP in Taiwan
Objectives
To characterize CAP and HCAP
Microbiological epidemiology
Disease severity PSI
Outcome length of stay mortality antimicrobial susceptibility and treatment outcomes
Microbiological epidemiology
Disease severity PSI
Outcome length of stay mortality
Study design
This is a retrospective multi-center cohort study to characterize microbiology and clinical outcomes in Taiwan
Data sources CAP or HCAP registered in 4 medical centers from Jan 1 2007 to Dec 31 2007 2 in north Taiwan 1 in central Taiwan 1 in south Taiwan Expected case number 800 HCAP and 1800 CAP
Study population
Those adult patients age 18 yo met the criteria of pneumonia are evaluated The patients are enrolled if they meet the following criteria
The diagnosis of pneumonia is established within 48h of hospitalization including time of emergency room
Pneumonia is defined as clinical suspicion of pneumonia cough short of breath expectorant with new-onset pulmonary infiltrates plus at least one of the following criteria
Fever 383 C or hypothermia 360 C axillary temp - 05
Leukocytosis increase of total WBC 10000cumm or leukopenia 4000cumm or band 10
Purulent airway secretion tracheal aspirates or sputum
Etiology diagnosis
Specimens obtained within 72h sputum tracheal aspirate BAL pleural effusion or blood
Urine antigen test for legionella or Streptococcus at the onset of pneumonia
Paired serology at admission and within 4th to 8th weeks
virus culture
Definition of definite pathogen 9Resp Med 20051079
Blood culture is accepted if the same microorganism is identified in a respiratory specimens and no other source for the positive blood culture could be identified
The isolate is cultured from pleural effusion
4 x fold risk in IgG antibody titer to L pneumoniae C pneumoniae or to any of respiratory virus antigens tested or a seroconversion of antibodies to M pneumoniae based on manufactures criteria
M pneumoniae IgM L pneumoniae IgG higher above 1128 or C pneumoniae high above 1256 are also defined as definite pathogens
Detection of L pneumoniae antigen in urine
Detection of S pneumoniae antigen in urine or isolation of S pneumoniae from purulent sputum
Bronchoscope guided study BAL 104cfu PSB 103cfu
Sputum or BAL revealing Pneumocystic carinii Mycobacterium tuberculosis Cryptococcus neoformans
Growth of fungi in the respiratory samples is considered diagnostic only in the presence of a concomitant positive blood culture growing the same microorganism candida Aspergillosis
Probable pathogens
Pathogen was confirmed by the isolatioin of a predominant organism from sputum or endotracheal aspirate
Comorbidity
Neoplastic disease
Any cancer except basal or squamous cell ca of the skin that was active at the time of presentation or diagnosed within one year of presentation
Liver disease
A clinical or histologic diagnosis of cirrhosis or another form of chronic liver disease such as chronic active hepatitis
Cardiac comorbid illness
Systolic or diastolic ventricular dysfunction documented by history physical examination chest radiograph echocardiogram multiple gated acquisition scan or left ventriculogram congestive heart failure New York heart association class III to IV
Disorders of the central nervous systems
A clinical diagnosis of stroke or transient ischemic attack or stroke documented by MRI or CT scan
Presence of symptomatic acute or chronic vascular or nonvascular encephalopathy dementia parkinsonism motor neuron disease etc
Renal
A history of chronic renal disease or abnormal blood urea nitrogen and creatinine concentration documented in the medical record Cr 2mgdL
Pulmonary
treatment for asthma or COPD or presence of interstitial lung disease bronchiectasis tuberculosis
DM
Lung cancer
Lung cancer active at the time of presentation or requiring anti-neoplastic treatment within the preceding one year
Autoimmune disease
Treatment for RA SLE polymyositis dermatomyositis etc
Having an immunocompromised state
equivalent to daily prednisolone 5mg or prednisolone 150 mg month
other immunosuppressive medications cyclophosphamide cyclosporine etc
sp organ transplantation
Definition of clinical items
Altered mental status disorientation with respect to person place or time that is not known to be chronic stupor or coma
Neutropenia
neutropenia with absolute neutrophil count 1000
smoking pack year
current smoker
exsmoker quitting for 6 months
non-smoker never smoking
Septic shock a persistent arterial hypotension in a septic patient
Hypotension is defined by a systolic arterial pressure 90mmHg or Mean arterial pressure 60mmHg after adequate volume resuscitation 5000 cc fluid resuscitationday or vasopressor dopamine 5mcgkgh to maintain blood pressure
Acute respiratory failure need mechanical ventilation support intubation and MV support only non-invasive mechanical ventilator
ICU admission admission to ICU during hospitalization
Length of ICU days staying in ICU
Hospital days days staying in the hospital from ER to hospital discharge discharge status
mortality including AAD with impending death
survival
without MV invasive and non-invasive MV
tracheostomy
ventilator dependent
Residence after discharge
Home nursing home RCW others
Organ failure
Respiratory failurePaO2FiO2300
Acute renal failureCr20 or Cr increase05 dl
Acute liver failureTotal bilirubin4 dl
CoagulopathyINR15 time or aPTT60 seconds
ThrombocytopeniaPlatelets 100000CUMM
All parameters required for the calculation of PSI Pneumonia Severity Index appendix at baseline will be collected
Definition of appropriateness of Empirical therapy Empirical antibiotic therapy is defined as antibiotic given during the first 48 hours for pneumonia The appropriateness of antibiotic therapy will be analyzed only for cases with causative organism probably and definite organisms identified Inadequacy therapy is defined as administration of an antibiotic to which the isolated pathogen was resistant according to the subsequent antimicrobial susceptibility results or the absence of antimicrobial agents to cover the identified pathogens In addition patients with aspiration pneumonia Aspiration pneumonia are defined as witnessed aspiration pneumonia and food or material noted in the upper or lower airways who had not received agents with anti-anaerobic coverage will be considered inappropriate
Definition of Treatment outcomes
In addition to collecting microbiological response clinical response data will be used for all patients Successfavorable clinical response will be defined as all or most of pretreatment signs and symptoms of the index infection have resolved or improved eg TPR shift toward normal and no additional antibiotic therapy or switching of regimen was required While failure will be defined as no apparent response to therapy persistence or progression of mostall pre-therapy signs and symptoms and additional antibiotic therapy or switching of regimen was documented
Cases will be classified as Indeterminate when no sufficient data is available to permit evaluation of microbiological or clinical outcome or patients underlying medical condition is too complicated to precluded classification as a success or failure
Data collection and analysis plan
Data from all sites will be pooled and combined Statistical analyses will be conducted with the use of SAS software version 82 SAS Institute Inc Cary NC USA Data will also be presented as mean -SD for continuous variables and proportions for categories variables The patient demographics and baseline characteristics will be tabulated The distribution of comorbidities disease severity causative organisms clinical condition and outcomes will be summarized and analyzed To detect the significant differences between groups Chi-square tests or Fisher exact test for categorical variables and the two-tailed t test or Mann-Whitney test for continuous variables will be employed when appropriate Statistical significance will be established at alpha 005 Reported P values will be two-sided
Pneumonia occurring outside of the hospital setting is regarded as community acquired pneumonia However pneumonia occurring in non-hospital long-term care facilities constituted a distinct type of pneumonia from CAP Kollef et al has justified health care associated pneumonia HCAP as a new category of pneumonia The HCAP patients are associated with severe disease higher mortality rate and greater length of stay and increased cost - HCAP are often at risk for multi-drug resistant bacterial pathogens such as Pseudomonas aeruginosa extended-spectrum beta-lactamase Klebsiella pneumoniae Acinetobacter baumannii and methicillin-resistant S aureus MRSA Health care facilities have not been defined in Taiwan Respiratory care ward RCW is a special unit to take care long-term ventilatory dependent patients in Taiwan Some of the patients get pneumonia and are referred back to medical centers Besides community-acquired P aeruginosa Acinetobacter baumannii or MRSA have been reported 3-8 Therefore the core-organisms of HCAP in Taiwan might be multi-drug resistant and the causes of inadequate initial antibiotics treatment The common pathogens were also unknown
Till now there are no data about the pathogens of HCAP in Taiwan We define the health-care facilities and initiate a retrospective study to characterize the microbiology and clinical outcome of Community acquired pneumonia and Health-Care-Associated pneumonia in Taiwan Further analysis will perform to confirm the differences between CAP an HCAP in Taiwan
Objectives
To characterize CAP and HCAP
Microbiological epidemiology
Disease severity PSI
Outcome length of stay mortality antimicrobial susceptibility and treatment outcomes
Microbiological epidemiology
Disease severity PSI
Outcome length of stay mortality
Study design
This is a retrospective multi-center cohort study to characterize microbiology and clinical outcomes in Taiwan
Data sources CAP or HCAP registered in 4 medical centers from Jan 1 2007 to Dec 31 2007 2 in north Taiwan 1 in central Taiwan 1 in south Taiwan Expected case number 800 HCAP and 1800 CAP
Study population
Those adult patients age 18 yo met the criteria of pneumonia are evaluated The patients are enrolled if they meet the following criteria
The diagnosis of pneumonia is established within 48h of hospitalization including time of emergency room
Pneumonia is defined as clinical suspicion of pneumonia cough short of breath expectorant with new-onset pulmonary infiltrates plus at least one of the following criteria
Fever 383 C or hypothermia 360 C axillary temp - 05
Leukocytosis increase of total WBC 10000cumm or leukopenia 4000cumm or band 10
Purulent airway secretion tracheal aspirates or sputum
Etiology diagnosis
Specimens obtained within 72h sputum tracheal aspirate BAL pleural effusion or blood
Urine antigen test for legionella or Streptococcus at the onset of pneumonia
Paired serology at admission and within 4th to 8th weeks
virus culture
Definition of definite pathogen 9Resp Med 20051079
Blood culture is accepted if the same microorganism is identified in a respiratory specimens and no other source for the positive blood culture could be identified
The isolate is cultured from pleural effusion
4 x fold risk in IgG antibody titer to L pneumoniae C pneumoniae or to any of respiratory virus antigens tested or a seroconversion of antibodies to M pneumoniae based on manufactures criteria
M pneumoniae IgM L pneumoniae IgG higher above 1128 or C pneumoniae high above 1256 are also defined as definite pathogens
Detection of L pneumoniae antigen in urine
Detection of S pneumoniae antigen in urine or isolation of S pneumoniae from purulent sputum
Bronchoscope guided study BAL 104cfu PSB 103cfu
Sputum or BAL revealing Pneumocystic carinii Mycobacterium tuberculosis Cryptococcus neoformans
Growth of fungi in the respiratory samples is considered diagnostic only in the presence of a concomitant positive blood culture growing the same microorganism candida Aspergillosis
Probable pathogens
Pathogen was confirmed by the isolatioin of a predominant organism from sputum or endotracheal aspirate
Comorbidity
Neoplastic disease
Any cancer except basal or squamous cell ca of the skin that was active at the time of presentation or diagnosed within one year of presentation
Liver disease
A clinical or histologic diagnosis of cirrhosis or another form of chronic liver disease such as chronic active hepatitis
Cardiac comorbid illness
Systolic or diastolic ventricular dysfunction documented by history physical examination chest radiograph echocardiogram multiple gated acquisition scan or left ventriculogram congestive heart failure New York heart association class III to IV
Disorders of the central nervous systems
A clinical diagnosis of stroke or transient ischemic attack or stroke documented by MRI or CT scan
Presence of symptomatic acute or chronic vascular or nonvascular encephalopathy dementia parkinsonism motor neuron disease etc
Renal
A history of chronic renal disease or abnormal blood urea nitrogen and creatinine concentration documented in the medical record Cr 2mgdL
Pulmonary
treatment for asthma or COPD or presence of interstitial lung disease bronchiectasis tuberculosis
DM
Lung cancer
Lung cancer active at the time of presentation or requiring anti-neoplastic treatment within the preceding one year
Autoimmune disease
Treatment for RA SLE polymyositis dermatomyositis etc
Having an immunocompromised state
equivalent to daily prednisolone 5mg or prednisolone 150 mg month
other immunosuppressive medications cyclophosphamide cyclosporine etc
sp organ transplantation
Definition of clinical items
Altered mental status disorientation with respect to person place or time that is not known to be chronic stupor or coma
Neutropenia
neutropenia with absolute neutrophil count 1000
smoking pack year
current smoker
exsmoker quitting for 6 months
non-smoker never smoking
Septic shock a persistent arterial hypotension in a septic patient
Hypotension is defined by a systolic arterial pressure 90mmHg or Mean arterial pressure 60mmHg after adequate volume resuscitation 5000 cc fluid resuscitationday or vasopressor dopamine 5mcgkgh to maintain blood pressure
Acute respiratory failure need mechanical ventilation support intubation and MV support only non-invasive mechanical ventilator
ICU admission admission to ICU during hospitalization
Length of ICU days staying in ICU
Hospital days days staying in the hospital from ER to hospital discharge discharge status
mortality including AAD with impending death
survival
without MV invasive and non-invasive MV
tracheostomy
ventilator dependent
Residence after discharge
Home nursing home RCW others
Organ failure
Respiratory failurePaO2FiO2300
Acute renal failureCr20 or Cr increase05 dl
Acute liver failureTotal bilirubin4 dl
CoagulopathyINR15 time or aPTT60 seconds
ThrombocytopeniaPlatelets 100000CUMM
All parameters required for the calculation of PSI Pneumonia Severity Index appendix at baseline will be collected
Definition of appropriateness of Empirical therapy Empirical antibiotic therapy is defined as antibiotic given during the first 48 hours for pneumonia The appropriateness of antibiotic therapy will be analyzed only for cases with causative organism probably and definite organisms identified Inadequacy therapy is defined as administration of an antibiotic to which the isolated pathogen was resistant according to the subsequent antimicrobial susceptibility results or the absence of antimicrobial agents to cover the identified pathogens In addition patients with aspiration pneumonia Aspiration pneumonia are defined as witnessed aspiration pneumonia and food or material noted in the upper or lower airways who had not received agents with anti-anaerobic coverage will be considered inappropriate
Definition of Treatment outcomes
In addition to collecting microbiological response clinical response data will be used for all patients Successfavorable clinical response will be defined as all or most of pretreatment signs and symptoms of the index infection have resolved or improved eg TPR shift toward normal and no additional antibiotic therapy or switching of regimen was required While failure will be defined as no apparent response to therapy persistence or progression of mostall pre-therapy signs and symptoms and additional antibiotic therapy or switching of regimen was documented
Cases will be classified as Indeterminate when no sufficient data is available to permit evaluation of microbiological or clinical outcome or patients underlying medical condition is too complicated to precluded classification as a success or failure
Data collection and analysis plan
Data from all sites will be pooled and combined Statistical analyses will be conducted with the use of SAS software version 82 SAS Institute Inc Cary NC USA Data will also be presented as mean -SD for continuous variables and proportions for categories variables The patient demographics and baseline characteristics will be tabulated The distribution of comorbidities disease severity causative organisms clinical condition and outcomes will be summarized and analyzed To detect the significant differences between groups Chi-square tests or Fisher exact test for categorical variables and the two-tailed t test or Mann-Whitney test for continuous variables will be employed when appropriate Statistical significance will be established at alpha 005 Reported P values will be two-sided
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None