The efficacy and safety of ceftaroline in the treatment of community-acquired pneumonia - the results of a multicentre, randomized, double-blind, phase III study of FOCUS 2
Patients hospitalized for community pneumonia of risk classes III-IV according to the PORT scale and treated with ceftaroline have shown high clinical and microbiological efficacy of the treatment.
Cefarolin is a new representative of the antibacterial group of cephalosporins with activity against pathogens which are most often the agents responsible for community-acquired pneumonia, including Streptococcus pneumoniae and Gram-negative pathogens.
A multicentre, randomized, double-blind, phase III study of FOCUS 2 evaluated the efficacy and safety of ceftaroline in the treatment of patients with community-acquired pneumonia.
The main objective of the study was to determine the statistical criterion of non-inferiority for the clinical cure of ceftaroline compared to the use of ceftriaxone in a population of clinical trials and a modified patient population to be treated ( m-ITT population)
The study involved patients hospitalized in general hospitals (and not in the ICU) for community pneumonia of risk classes III-IV according to the PORT scale, who needed intravenous antibacterial treatment. The patients were randomly assigned in a 1: 1 ratio into two groups: the first received 600 mg of ceftaroline iv every 12 hours, the second received 1 g iv of ceftriaxone every 24 hours. During the study, the frequency of clinical recovery and the frequency of microbiological efficacy were evaluated therapy and adverse events.
A total of 627 patients participated in the study, of which 315 received ceftaroline, 307 received ceftriaxone. Patients in both clinical groups had comparable baseline data.
The clinical recovery rate in the population to be evaluated was 82.1% (193/235) in the ceftaroline group and 77.2% (166/215) in the ceftriaxone group (difference of 4.9%, confidence interval 95% -2 5-12.5); in the modified patient population, 81.3% (235/289) in the ceftaroline group and 75.5% (206/273) in the ceftriaxone group (difference 5.9%, 95% confidence interval - 1.0-12, 7).
Clinical cure rate for community-acquired pneumonia caused by S. pneumoniae, in the modified microbiological population of patients to be treated, was 83.3% (35/42) and 70.0% (28 / 40) in the ceftaroline and ceftriaxone groups, respectively.
Both drugs were characterized by good tolerance with a similar incidence of adverse events, serious adverse events, frequency of death and discontinuation of the drug due to the development of adverse events. The most commonly reported adverse events in treatment with ceftaroline were diarrhea, headache, hypokalemia, sleep disturbance and phlebitis, and treatment with cetriaxone was diarrhea, sleep disturbance, phlebitis and hypertension.
Thus, during this study, it was demonstrated that in the treatment of community-level class III-IV risk pneumonia at PORT scale with ceftaroline, a high frequency of clinical cure and a microbiological response to treatment can be obtained. Ceftaroline has good tolerance and a favorable safety profile comparable to ceftriaxone. In connection with the above, ceftaroline can be considered a promising and antimicrobial drug in the treatment of community-acquired pneumonia.