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A reduction in the use of antibiotics to a third, lower antibiotic prescriptions and fewer side effects without negative implications for the patients: These are the results of the multi-centric, randomised ProHOSP study on the use of a Procalcitonin (PCT) marker for lower respiratory tract infections (LRTI). The aim of this high-investment, unilateral equivalence analysis in this patient collective was to compare a systematic application of the biomarker by B·R·A·H·M·S with the current standard care practice in emergency hospitalisation. The results have been published in JAMA (Journal of the American Medical Association) and are considered groundbreaking for the future of antibiotics administration.
For lower respiratory tract infections, clinical symptoms and prevalent lab reports are often unable to reliably indicate if the cause is viral or bacterial and whether or not an antibiotic treatment would be effective. Consequently, 75 percent of all patients with lower respiratory tract infections are treated with antibiotics, even if the cause of the illness is viral. However, the unnecessary use of antibiotics is an important factor in increasing bacterial resistances, which in turn lead to increasing medical costs and undesirable side effects.
The PCT marker is an promising step towards avoiding the unnecessary administration of antibiotics: In normal metabolism, Procalcitonin is a precursor of the hormonally active calcitonin, which regulates the calcium and phosphate balance in the body along with the so-called parathormone. In a healthy person, PCT is evident in very weak concentrations, since it is produced only in the thyroid gland and is promptly converted to the mature hormone. However, in the event of bacterial infections, it is produced by nearly all cell systems and released in the blood circulation, where it is then found in high concentrations. In contrast, PCT increases marginally or sometimes not at all in viral and auto-immune diseases or allergic reactions.
ProHOSP: PCT algorithm achieves better results as compared to treatment strategies dictated by standard care practice
Initial, smaller investigations have indicated that a PCT-based algorithm can help reduce the use of antibiotics in LRTIs. Now, the recently revealed results of a large, multi-centric, randomised study conducted in Switzerland confirm the same. This study examined the extent to which the use of PCT monitoring can be equated with a treatment based on internationally established care practices: The study conducted in 6 clinics involved 1359 analysable patients with predominantly severe lower respiratory tract infections. The primary endpoint of the study was a statistical construct of all negative implications for the patients within 30 days after emergency hospitalisation, including death, hospitalisation in intensive care, onset of disease-specific complications and a recurring infection: Patients with PCT base demonstrated a lower share of effect on them with 15.4 percent as opposed to the control group (18.9 percent).
Furthermore, the prescription rates of antibiotics were significantly lower in the entire PCT group at 12.2 percent as well as in the LRTI sub-groups with PCT base. The total duration of antibiotics administration also dropped by 34.8 percent with the PCT algorithm (5.7 vs. 8.7 days). The same was observed for patient sub-groups with pneumonia contracted during ambulant treatment (CAP, 7.2 vs. 10.7 days, -32.4 percent), aggravated chronic obstructive pulmonary disease (COPD, 2.5 vs. 5.1 days, -50.4 percent) and acute bronchitis (1.0 vs. 2.8 days, -65.0 percent). Additionally, a decrease of 8.2 percent in side effects related with antibiotics was observed in the PCT base (19.8 percent vs. 28.1 percent in control base). The duration of hospitalisation was same in both study groups (9.4 days for PCT vs. 9.2 days in control base).
The PCT algorithm
The determination of PCT took place within 20 minutes during the study with the Kryptor from B·R·A·H·M·S. Results were available within an hour in every case. Instructions on the algorithm were available on the web: Initiating or continuing antibiotic treatment was strongly discouraged for PCT values below < 0.1 µg/l or discouraged in case of ≤0.25 µg/l. On the other hand, introduction or continuation of antibiotic treatment was recommended for PCT values > 0.25 µg/l and strongly recommended for >0.5 µg/l.
Another analysis was conducted after 6 to 24 hours for a patient who had not been prescribed antibiotic treatment. After 3, 5 and 7 days, PCT was re-analysed using the algorithm for patients of the PCT group with increased values and antibiotic treatment. If the patients had very high PCT values of > 10 µg/l to begin with, ending the antibiotic treatment was recommended if a decrease of 80 percent was evident. It was strongly recommended if there was a decrease of 90 percent from the initial value. In case of ambulant patients, the analysis was made again only if the symptoms became worse.
B·R·A·H·M·S Aktiengesellschaft is engaged in the research, development, production and marketing of innovative diagnostic biomarkers. It is one of the three largest biotech companies in Germany. The company markets its products in more than 65 countries through its subsidiaries and distribution companies. In-house laboratory systems and globally operating licensees also contribute to this end. The B·R·A·H·M·S Aktiengesellschaft’s headquarters are in Hennigsdorf, close to Berlin, where 220 of the worldwide over 400 employees are working.