- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00471757
Etiology of Community Acquired Pneumonia (CAP)
June 11, 2018 updated by: University of Pittsburgh
The proposed study aims to provide current information, etiology and outcome of community-acquired pneumonia (CAP), risk factors for for CAP in isolates of Streptococcus pneumoniae and Haemophilus influencae, Mycoplasma pneumoniae, chlamydia pneumoniae and Legionella.
Risk factors, including patient demographics, comorbid illnesses, setting of presentation, causative organisms, antibiotic history, and resistance profiles will be assessed and outcome will be recorded.
Study Overview
Status
Completed
Detailed Description
The following information will be collected: age, sex, occupation, hospital location at the time of positive culture (ER, medical ward, ICU etc), date of positive culture, prior hospitalization, receipt of outpatient dialysis, home care or other regular medical care (eg, outpatient chemotherapy), presence of invasive devices, receipt of antibiotics, including their type and whether they were adequate for the resistance profile of the organism, prior positive microbiologic cultures, time and location of positive cultures, underlying diseases and severity of illness, co-morbid illnesses, presence of urinary or intravascular devices, recent immunomodulative therapies or radiation therapy, physical exam findings, laboratory and radiographical data, antimicrobial usage within 30 days of onset of the infection, microbiological data and resistance patterns, choice of antibiotics once organism identified, bacteriological outcomes, laboratory results, demographic information, medications, clinical outcome,gender, height, weight, ethnicity, and past medical history.
We will collect information retrospectively.
Study Type
Observational
Enrollment (Actual)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
streptococcus pneumoniae positive
Description
Inclusion Criteria:
- All patients with Streptococcus pneumoniae, Haemophilus influencae, Mycoplasma pneumoniae, chlamydia pneumoniae and Legionella species infections during the time period the study will be reviewed. A community-associated pneumonia isolate will be defined as one which was recovered from a clinical culture from a patient at UPMC who had no established risk factors for infection with an antibiotic resistant organism. Established risk factors are defined as: Isolation of the organism two or more days after admission for hospitalization OR history of hospitalization, surgery, dialysis, or residence in a long-term care facility within one year before the culture date OR The presence of an indwelling catheter or percutaneous medical device (eg, tracheostomy tube, gastrostomy tube, or Foley catheter) at the time of the culture OR Previous isolation of an antibiotic resistant organism.
Exclusion Criteria:
- Does not meet entry criteria
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: David L Paterson, MD, University of Pittsburgh/University of Pittsburgh Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2007
Primary Completion (Actual)
June 1, 2017
Study Completion (Actual)
June 1, 2017
Study Registration Dates
First Submitted
May 9, 2007
First Submitted That Met QC Criteria
May 9, 2007
First Posted (Estimate)
May 10, 2007
Study Record Updates
Last Update Posted (Actual)
June 13, 2018
Last Update Submitted That Met QC Criteria
June 11, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Lung Diseases
- Gram-Negative Bacterial Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Streptococcal Infections
- Gram-Positive Bacterial Infections
- Pneumonia, Bacterial
- Pneumococcal Infections
- Mycoplasmatales Infections
- Mycoplasma Infections
- Pneumonia
- Pneumonia, Pneumococcal
- Pneumonia, Mycoplasma
Other Study ID Numbers
- PRO07040291
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
not sharing
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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