Safety and efficacy of tigecycline compared to levofloxacin in the treatment of community-acquired pneumonia: results of a randomized phase 3 trial

The journal Microbiology Diagnostics and Infectious Diseases published the results of a phase 3, randomized, double-blind, controlled study that compared the efficacy and safety of tigecycline and levofloxacin in the treatment of patients with community-acquired pneumonia.

Taigecycline, a new antibacterial drug from the glycylcycline group, has high in vitro activity against most of the causative agents of community-acquired pneumonia, including antibiotic-resistant strains.

Hospitalized patients with community-acquired pneumonia (n = 418) were randomized to receive either tigecycline or levofloxacin iv. After receiving 6 or more doses of the study drug in / in, patients may be transferred to levofloxacin internally. The duration of treatment varied from 7 to 14 days.

As the main criterion for evaluating the efficacy of the treatment, we considered the clinical response to treatment in patients undergoing clinical evaluation (tigecycline n = 138; levofloxacin n = 156) and in a clinically modified population of patients for whom treatment was prescribed (c-mITT) (tigecycline n = 191; levofloxacin n = 203). The clinical cure rate, which was assessed during the healing visit, was 90.6% and 87.2% in the group of patients undergoing clinical evaluation of tigecycline and levofloxacin, respectively, and 78% and 77.8% when analyzed in a clinical study. a modified population of patients who have been prescribed treatment.

Nausea and vomiting occurred reliably more often in the tigecycline group, while an increase in liver enzymes (ALT and AST) was significantly more often seen in patients receiving levofloxacin. There were statistically significant differences in the length of hospital stay, the average duration of IV or oral therapy, the frequency of repeat hospitalizations and in the number of patients in each group who were transferred to oral levofloxacin.

Thus, this study demonstrated that tigecycline is not inferior in efficacy and safety to levofloxacin in the treatment of patients hospitalized for community-acquired pneumonia.