NCT Number: NCT00415753
Procalcitonin as a Marker of Bacterial Pneumonia
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.
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Department of Infectious Diseases, Skejby Hospital, Aarhus N, Denmark
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
Antibiotic use
-
Length of stay in hospital
Secondary outcomes
-
The proportion of patients where the doctor chooses to disregard treatment guidelines
Sponsors and collaborators
Lead sponsor
Aarhus University Hospital Skejby
Other
Registry information
Important dates
- Study start
- 2006
- Primary completion
- 2007
- Study completion
- 2007
- First posted
- Dec 25, 2006
- Registry last updated
- May 23, 2008
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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