Usefulness of Microbiological Tests in Community-Acquired Pneumonia

February 26, 2009 updated by: Hospital Arnau de Vilanova

Prospective Study on Benefits Derived From Microbiological Tests in 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 Overview

Status

Unknown

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

Observational

Enrollment (Anticipated)

250

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

  • Spain
      • Lleida, Spain, 25198
        • Recruiting
        • Hospital Arnau De Vilanova
        • Contact:
        • Sub-Investigator:
          • Agustin Ruiz-González, M.D.

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

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Clinical and economic consequences obtained with the antibiotic selection in basis to early mcrobiological results

Secondary Outcome Measures

Outcome Measure
Importance of polimicrobial etiology in community-acquired pneumonia
Practice usefulness of urinary antigen detection tests in pneumonia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Arnau de Vilanova

Investigators

  • Principal Investigator: Miquel Falguera, M.D., Hospital Arnau de Vilanova (Lleida)

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

April 1, 2006

Study Completion (Anticipated)

May 1, 2008

Study Registration Dates

First Submitted

April 7, 2006

First Submitted That Met QC Criteria

April 7, 2006

First Posted (Estimate)

April 11, 2006

Study Record Updates

Last Update Posted (Estimate)

February 27, 2009

Last Update Submitted That Met QC Criteria

February 26, 2009

Last Verified

February 1, 2009

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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