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Usefulness of Microbiological Tests in Community-Acquired Pneumonia

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ClinicalTrials.gov Identifier: NCT00312741
Recruitment Status : Unknown
Verified February 2009 by Hospital Arnau de Vilanova.
Recruitment status was:  Recruiting
First Posted : April 11, 2006
Last Update Posted : February 27, 2009
Sponsor:
Information provided by:
Hospital Arnau de Vilanova

Brief Summary:
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.

Condition or disease Intervention/treatment
Community-Acquired Pneumonia Procedure: empirical versus microbiological guided 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
Estimated Enrollment : 250 participants
Time Perspective: Prospective
Official Title: Prospective Study on Benefits Derived From Microbiological Tests in Community-Acquired Pneumonia
Study Start Date : April 2006
Estimated Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia
U.S. FDA Resources




Primary Outcome Measures :
  1. Clinical and economic consequences obtained with the antibiotic selection in basis to early mcrobiological results

Secondary Outcome Measures :
  1. Importance of polimicrobial etiology in community-acquired pneumonia
  2. Practice usefulness of urinary antigen detection tests in pneumonia


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00312741


Contacts
Contact: Miquel Falguera, M.D. 0034-973248100 ext 2679 mfalguera@comll.cat

Locations
Spain
Hospital Arnau de Vilanova Recruiting
Lleida, Spain, 25198
Contact: Miquel Falguera, M.D.    0034-973248100 ext 2679    mfalguera@comll.es   
Sub-Investigator: Agustin Ruiz-González, M.D.         
Sponsors and Collaborators
Hospital Arnau de Vilanova
Investigators
Principal Investigator: Miquel Falguera, M.D. Hospital Arnau de Vilanova (Lleida)

ClinicalTrials.gov Identifier: NCT00312741     History of Changes
Other Study ID Numbers: pneumonia1
First Posted: April 11, 2006    Key Record Dates
Last Update Posted: February 27, 2009
Last Verified: February 2009

Keywords provided by Hospital Arnau de Vilanova:
community-acquired pneumonia
microbiological tests
urinary antigen
selection of antibiotic treatment

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections