An open, randomised, multi-centre study comparing the safety and efficacy of sitafloxacin and imipenem/cilastatin in the intravenous treatment of hospitalised patients with pneumonia

This was a phase II. randomised, open-label, multi-centre study to assess t he safety. tolerability, and efficacy of sitafloxacin (DU-6859a, 400 mg onc e daily) compared with imipenem (imipenem/cilastatin. 500 me three times da ily) in the treatment of hospitalised patients with pneumonia. Patients (n = 69) were entered into the study in the intent-to-treat group, 35 in the s itafloxacin and 34 in the imipenem group. Patients (n = 65) were included i n the clinically evaluable population and 42 in the bacteriologically evalu able population. Baseline demographic data and clinical characteristics wer e similar for both treatment groups and across all patient populations. The incidence, severity and type of adverse events were similar in both treatm ent groups. The frequency of adverse events, which were considered to be re lated to the study of drugs was low and generally similar between the two g roups. Mild transient increases in alanine aminotransferase and alkaline ph osphatase occurred in the sitafloxacin treatment group, but there were no a pparent trends in the other serum enzyme levels. The clinical response at t he first and second follow-up assessments indicated that 94-97% of patients in the clinically evaluable population and 91% of patients in the intent-t o-treat population were classified as cured in both treatment groups. The b acteriological response was classified as satisfactory for all patients (10 0%) in the bacteriologically evaluable population in the imipenem treatment group and satisfactory for 90 and 95% of cases at the first and second fol low-up assessments in the bacteriologically evaluable population in the sit afloxacin treatment group, respectively. In conclusion, for the treatment o f pneumonia, sitafloxacin was considered as safe and as tolerable as imipen em and preliminary data from this study suggest that it may have similar ef ficacy. (C) 2001 Elsevier Science B.V. and International Society of Chemoth erapy All rights reserved.