Procalcitonin as a Marker of Bacterial Pneumonia

This study has been completed.
Sponsor:
Information provided by:
Aarhus University Hospital Skejby
ClinicalTrials.gov Identifier:
NCT00415753
First received: December 22, 2006
Last updated: May 22, 2008
Last verified: May 2008
  Purpose

Objective: To evaluate PCT as a marker of bacterial community acquired pneumonia in a Danish Hospital setting. To test if it is possible to reduce the use of antibiotics and the length of stay in hospital, and the willingness of the clinicians to take this new marker under advisement in their choice of treatment.

The study is a randomised, controlled intervention study. All adult patients admitted to the Department of Infectious Disease at Skejby hospital suspected of a lower respiratory tract infection (e.g. CAP, acute exacerbation of COPD and bronchitis) are eligible for inclusion. Patients are randomised to have either PCT guided treatment or standard care, in which case the doctor will not learn the PCT test result. In the PCT group the antibiotic treatment will be based on serum PCT as follows: If PCT is less than 0.25 µg/L antibiotic treatment is discouraged; if PCT is greater than 0.25 µg/L antibiotic treatment is encouraged and if PCT is greater than 0.5 µg/L antibiotic treatment is strongly encouraged. The treating doctor is allowed to overrule the treatment guidelines. The control group will receive antibiotics according to usual practice.

The primary endpoints are antibiotic use and length of stay in hospital. Secondary endpoint is the proportion of patients where the treating doctor chooses to disregard the guidelines.


Condition Intervention
Pneumonia
Bronchitis
COPD
Behavioral: No antibiotics if se-procalcitonin is below stated limit

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Resource links provided by NLM:


Further study details as provided by Aarhus University Hospital Skejby:

Primary Outcome Measures:
  • Antibiotic use
  • Length of stay in hospital

Secondary Outcome Measures:
  • The proportion of patients where the doctor chooses to disregard treatment guidelines

Enrollment: 223
Study Start Date: June 2006
Study Completion Date: August 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • suspected lower respiratory tract infection
  • must be able to give consent

Exclusion Criteria:

  • age under 18 years
  • not able to give consent
  • admitted not primarily because of the respiratory tract infection
  • hospital acquired infections
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00415753

Locations
Denmark
Department of Infectious Diseases, Skejby Hospital
Aarhus N, Denmark, 8200
Departement of Medicin, Silkeborg Hospital
Silkeborg, Denmark, 8600
Sponsors and Collaborators
Aarhus University Hospital Skejby
Investigators
Study Chair: Finn T Black, Professor Aarhus Universityhospital
Principal Investigator: Kristina B Kristoffersen Aarhus University Hospital Skejby
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Skejby Hospital
ClinicalTrials.gov Identifier: NCT00415753     History of Changes
Other Study ID Numbers: 271-05-0765
Study First Received: December 22, 2006
Last Updated: May 22, 2008
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: The Regional Committee on Biomedical Research Ethics

Additional relevant MeSH terms:
Bronchitis
Pneumonia
Bronchial Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on October 20, 2014