Procalcitonin as a Marker of Bacterial Pneumonia
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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 |
- Antibiotic use
- Length of stay in hospital
- 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 |
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| Denmark | |
| Department of Infectious Diseases, Skejby Hospital | |
| Aarhus N, Denmark, 8200 | |
| Departement of Medicin, Silkeborg Hospital | |
| Silkeborg, Denmark, 8600 | |
| Study Chair: | Finn T Black, Professor | Aarhus Universityhospital |
| Principal Investigator: | Kristina B Kristoffersen | Skejby Hospital |
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:
|
Pneumonia, Bacterial Bronchitis Pneumonia Bacterial Infections Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections |
Bronchial Diseases Lung Diseases, Obstructive Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013