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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00471757
Other study ID # PRO07040291
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 2007
Est. completion date June 2017

Study information

Verified date June 2018
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date June 2017
Est. primary completion date June 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Locations

Country Name City State
United States University of Pittsburgh Medical Center Pittsburgh Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

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