Clinical trial NCT00415753: Procalcitonin as a Marker of Bacterial Pneumonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pneumonia
Bronchitis
COPD
Lead sponsor: Aarhus University Hospital Skejby
Sponsor class: OTHER
First posted: 2006-12-25
Enrollment: 223
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: DIAGNOSTIC

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.


Eligibility 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

Primary outcomes:
measure: Antibiotic use
measure: Length of stay in hospital
Secondary outcomes:
measure: The proportion of patients where the doctor chooses to disregard treatment guidelines
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Department of Infectious Diseases, Skejby Hospital
city: Silkeborg
country: Denmark
facility: Departement of Medicin, Silkeborg Hospital
Study officials:
affiliation: Aarhus Universityhospital
name: Finn T Black, Professor
role: STUDY_CHAIR
affiliation: Aarhus University Hospital Skejby
name: Kristina B Kristoffersen
role: PRINCIPAL_INVESTIGATOR
References:
citation: Christ-Crain M, Jaccard-Stolz D, Bingisser R, Gencay MM, Huber PR, Tamm M, Muller B. Effect of procalcitonin-guided treatment on antibiotic use and outcome in lower respiratory tract infections: cluster-randomised, single-blinded intervention trial. Lancet. 2004 Feb 21;363(9409):600-7. doi: 10.1016/S0140-6736(04)15591-8.
citation: Kristoffersen KB, Sogaard OS, Wejse C, Black FT, Greve T, Tarp B, Storgaard M, Sodemann M. Antibiotic treatment interruption of suspected lower respiratory tract infections based on a single procalcitonin measurement at hospital admission--a randomized trial. Clin Microbiol Infect. 2009 May;15(5):481-7. doi: 10.1111/j.1469-0691.2009.02709.x. Epub 2009 Mar 5.