Pneumonia Clinical Trial
Official title:
Procalcitonin as a Marker of Antibiotic Therapy in Patients With Lower Respiratory Tract Infections. Can Measurement of Procalcitonin Reduce the Use of Antibiotics?
The purpose of this study is to investigate weather or not the use of a procalcitonin(PCT)-based treatment in the daily clinical work could lower the consumption of antibiotics in patients with lower respiratory tract infections.
An increasing amount of antibiotics are being consumed and along with the increased
resistance they carry along, they pose an increasing problem for the health sector. A method
to decrease the use of antibiotics is highly desirable and of great importance in order to
halt the spread of multi-resistant bacteria that is becoming an increasing problem in
Denmark.
Lower respiratory tract infections such as pneumonia and acute exacerbations of chronic
obstructive pulmonary disease (AECOPD) are frequent reasons for patient contact in both the
primary and secondary sectors. Identifying which patients that could benefit from treatment
with antibiotics is a great challenge to the health sector. This is why patients often are
treated with antibiotics if there is a mere suspicion of the above-mentioned disorders, even
if they are not proved for certain.
An increasing amount of data suggests that procalcitonin (PCT) could serve as a possible
marker of respiratory tract infections caused by bacteria. Alongside the conventional
clinical parameters, the level of PCT is regarded as a promising means to decide whether to
treat with antibiotics and how long such a treatment should endure. When an infection is
under control by the immune system of the individual or by treatment with antibiotics, the
level of PCT will diminish by 50% on a daily basis. Accordingly, a decline in the PCT levels
should indicate a favorable response to antibiotic treatment. Therefore there is a need to
further investigate if the PCT levels can be used, in the everyday clinic, to diagnose
patients with pneumonia or AECOPD caused by bacteria and if this could have an effect on the
use of antibiotics, thus optimizing the treatment of the patients.
The purpose of this research project is to compare the amount of antibiotics consumed using
standard treatment and treatment based on the PCT levels of patients with lower respiratory
tract infections, respectively.
With the research at hand, a clarification of whether a measurement of PCT can serve as a
diagnostic tool to distinguish between bacterial and non-bacterial infections in patients
that are suspected of having pneumonia or AECOPD is desirable. In extension, this study
wants to clarify if the PCT levels can indicate when a potential antibiotic treatment should
be initiated and if the use of a PCT-based treatment in the daily clinical work could lower
the consumption of antibiotics.
The hypothesis is that PCT will be increased (≥0.25 µg/l and ≥0.10 µg/l for pneumonia and
AECOPD respectively) in lower respiratory tract infections caused by bacteria, whereas PCT
should only be slightly increased in non-bacterial lower respiratory tract infections if at
all. It is expected that using a PCT-based treatment in lower respiratory tract infections
could lower the consumption of antibiotics, while at the same time it should not prove a
greater health risk to patients than by using a standard treatment.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic
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