Microbiology and Clinical Outcome of Pneumonia
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ClinicalTrials.gov Identifier: NCT00873522 |
Recruitment Status : Unknown
Verified March 2009 by Taichung Veterans General Hospital.
Recruitment status was: Recruiting
First Posted : April 1, 2009
Last Update Posted : April 1, 2009
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Tracking Information | ||||
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First Submitted Date | March 31, 2009 | |||
First Posted Date | April 1, 2009 | |||
Last Update Posted Date | April 1, 2009 | |||
Study Start Date | March 2008 | |||
Estimated Primary Completion Date | March 2010 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures |
Success/favorable clinical response after treatment for pneumonia [ Time Frame: weeks ] | |||
Original Primary Outcome Measures | Same as current | |||
Change History | No Changes Posted | |||
Current Secondary Outcome Measures | Not Provided | |||
Original Secondary Outcome Measures | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | Microbiology and Clinical Outcome of Pneumonia | |||
Official Title | Microbiology and Clinical Outcome of Community Acquired Pneumonia and Health-Care-Associated Pneumonia in Taiwan: a Multi-Center Study | |||
Brief Summary |
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 |
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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:
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 y/o) 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:
Etiology diagnosis
Probable pathogens:
Comorbidity:
Renal:
treatment for asthma, or COPD, or presence of interstitial lung disease, bronchiectasis, tuberculosis,
Lung cancer:
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
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 pathogen(s). 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. Success/favorable clinical response will be defined as all or most of pretreatment signs and symptoms of the index infection have resolved or improved (e.g.: 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 most/all 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 patient's 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 8.2 (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 =0.05. Reported P values will be two-sided. |
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Study Type | Observational | |||
Study Design | Observational Model: Cohort Time Perspective: Retrospective |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Non-Probability Sample | |||
Study Population | Those adult patients (age ≥ 18 y/o) met the criteria of pneumonia are evaluated. The patients are enrolled if they meet the following criteria [9] .
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Condition | Pneumonia | |||
Intervention | Not Provided | |||
Study Groups/Cohorts |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Unknown status | |||
Estimated Enrollment |
2600 | |||
Original Estimated Enrollment | Same as current | |||
Estimated Study Completion Date | March 2010 | |||
Estimated Primary Completion Date | March 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria: CAP criteria:
HCAP criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Taiwan | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT00873522 | |||
Other Study ID Numbers | C08012 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Current Responsible Party | Chieh-Liang Wu, Department of Respiratory Therapy, Taichung Veterans General Hospital | |||
Original Responsible Party | Same as current | |||
Current Study Sponsor | Taichung Veterans General Hospital | |||
Original Study Sponsor | Same as current | |||
Collaborators |
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Investigators |
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PRS Account | Taichung Veterans General Hospital | |||
Verification Date | March 2009 |