Usefulness of Microbiological Tests in Community-Acquired Pneumonia

Community-Acquired Pneumonia Clinical Trial

Official title:

Prospective Study on Benefits Derived From Microbiological Tests in Community-Acquired Pneumonia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00312741
• Other study ID #: pneumonia1
• Status: Recruiting
• Phase: N/A
• First received: April 7, 2006
• Last updated: February 26, 2009
• Start date: April 2006
• Est. completion date: May 2008

Study information

• Verified date: February 2009
• Source: Hospital Arnau de Vilanova
• Contact: Miquel Falguera, M.D.
• Phone: 0034-973248100
• Email: mfalguera[@]comll.cat
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Community-Acquired Pneumonia
• Pneumonia

Intervention

Procedure:
• empirical versus microbiological guided treatment

Locations

Country	Name	City	State
Spain	Hospital Arnau de Vilanova	Lleida

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Arnau de Vilanova

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical and economic consequences obtained with the antibiotic selection in basis to early mcrobiological results
Secondary	Importance of polimicrobial etiology in community-acquired pneumonia
Secondary	Practice usefulness of urinary antigen detection tests in pneumonia