- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00312741
Usefulness of Microbiological Tests in Community-Acquired Pneumonia
Prospective Study on Benefits Derived From Microbiological Tests in Community-Acquired Pneumonia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In community-acquired pneumonia, identification of the etiologic agent has theoretically important advantages. For individual patients, it facilitates the administration of a targeted, narrow-spectrum antibiotic therapy that may improve the efficacy of treatment, and reduces risks of antibiotic-related toxicity. For the community, microbiologic results contribute to understanding the local microbial epidemiology of community-acquired pneumonia and the antimicrobial resistance patterns of pathogens, information that is essential in the instauration or modification of empiric treatment regimens.
Guidelines recommend that all admitted patients with community-acquired pneumonia should have a collection of two sets of blood cultures, a good quality sputum sample for Gram stain and culture, a sample of pleural fuid if present and, for severe patients, an urine sample for antigen detection. In contrast, several prospective studies (usually without include urinary tests) concluded that these microbiological studies have limited value in the management of patients admitted with community-acquired pneumonia.
In addition, microbiological studies could provide erroneous or incomplete information. Thus, investigations has showed false-positive results from pneumococcal antigen detection in urine caused by a frequent persistence of positivity after infection or a nasopharyngeal or bronchial colonization. Other authors suggested that community-acquired pneumonia is a polymicrobial infection; consequently, despite the detection of a true microorganism, treatment needs to be also addressed against other potential pathogenic agents.
The purpose of the study is to assess the clinical and the economic derived from the initial microbiological studies, including antigen detection tests in urine for Streptococcus pneumoniae and Legionella pneumophila, in patients with community-acquired pneumonia.
The hypothesis is that community-acquired pneumonia is usually a monomicrobial infection. Therefore, early detection of the etiology allows to select the most active, narrow-spectrum, and cheap, and less toxic antibiotic agent.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Miquel Falguera, M.D.
- Phone Number: 2679 0034-973248100
- Email: mfalguera@comll.cat
Study Locations
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Lleida, Spain, 25198
- Recruiting
- Hospital Arnau de Vilanova
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Contact:
- Miquel Falguera, M.D.
- Phone Number: 2679 0034-973248100
- Email: mfalguera@comll.es
-
Sub-Investigator:
- Agustin Ruiz-González, M.D.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age: 18 years and above
- Clinical and radiological diagnosis of community-acquired pneumonia
- Informed consent of patient
- Hospital admission
Exclusion Criteria:
- Prior hospital admission (less than 15 days)
- Alternative diagnosis at the discharge
- Immunosuppression (HIV infection, immunosuppressive therapies, neutropenia)
- Risk factors for unusual etiologies
- Patient is pregnant
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Clinical and economic consequences obtained with the antibiotic selection in basis to early mcrobiological results
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Secondary Outcome Measures
Outcome Measure |
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Importance of polimicrobial etiology in community-acquired pneumonia
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Practice usefulness of urinary antigen detection tests in pneumonia
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Miquel Falguera, M.D., Hospital Arnau de Vilanova (Lleida)
Study record dates
Study Major Dates
Study Start
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- pneumonia1
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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