Moxifloxacin Monotherapy Is Effective in Hospitalized Patients with Community-Acquired Pneumonia: The MOTIV Study—A Randomized Clinical Trial

Background. The aim of this study was to show that sequential intravenous and oral moxifloxacin monotherapy (400 mg once per day) is as efficacious and safe as a combination regimen (intravenous ceftriaxone, 2 g once per day, plus sequential intravenous and oral levofloxacin, 500 mg twice per day) in patients hospitalized with community-acquired pneumonia. Methods. We conducted a prospective, multicenter, randomized, double-blind noninferiority trial. Patients with a Pneumonia Severity Index (PSI) of III–V were stratified on the basis of PSI risk class before randomization. The primary efficacy end point was clinical response at test of cure (4–14 days after the completion of treatment). Secondary efficacy end points were clinical and bacteriological response at end of treatment (days 7–14) and at follow-up assessment (21–28 days after the end of treatment), overall mortality, and mortality attributable to pneumonia. Results. Seven hundred thirty-three patients were enrolled in the study (368 in the moxifloxacin arm and 365 in the comparator arm); 49% had a PSI of IV, and 10% had a PSI of V. Of 569 patients (291 in the moxifloxacin arm and 278 in the comparator arm) valid for per-protocol analysis, the overall clinical cure rates at test of cure were 86.9% for moxifloxacin and 89.9% for the comparator regimen (95% confidence interval, −8.1% to 2.2%). Bacteriological success at test of cure was 83.3% for moxifloxacin and 85.1% for the comparator regimen (95% confidence interval, −15.4% to 11.8%). There were no significant differences between moxifloxacin and comparator treatments in the incidence of treatment-emergent adverse events or in mortality. Conclusions. Monotherapy with sequential intravenous/oral moxifloxacin was noninferior to treatment with ceftriaxone plus levofloxacin combination therapy in patients with community-acquired pneumonia who required hospitalization. Clinical trials registration. The MOxifloxacin Treatment IV Study is registered at NLM Clinical Trials (registration number NCT00431678).