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Procalcitonin as a Marker of Bacterial Pneumonia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00415753
Recruitment Status : Completed
First Posted : December 25, 2006
Last Update Posted : May 23, 2008
Information provided by:
Aarhus University Hospital Skejby

Brief Summary:

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 or disease Intervention/treatment Phase
Pneumonia Bronchitis COPD Behavioral: No antibiotics if se-procalcitonin is below stated limit Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 223 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Study Start Date : June 2006
Actual Primary Completion Date : April 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Antibiotic use
  2. Length of stay in hospital

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

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT00415753

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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
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Study Chair: Finn T Black, Professor Aarhus Universityhospital
Principal Investigator: Kristina B Kristoffersen Aarhus University Hospital Skejby

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Skejby Hospital Identifier: NCT00415753    
Other Study ID Numbers: 271-05-0765
First Posted: December 25, 2006    Key Record Dates
Last Update Posted: May 23, 2008
Last Verified: May 2008
Additional relevant MeSH terms:
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Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Bronchial Diseases
Lung Diseases, Obstructive
Anti-Bacterial Agents
Anti-Infective Agents