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

Abstract

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, Ϫ8.1% to 2.2%). Bacteriological success at test of cure was 83.3% for moxifloxacin and 85.1% for the comparator regimen (95% confidence interval, Ϫ15.4% 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).

Efficacy and safety of moxifloxacin for community-acquired bacterial pneumonia based on pharmacokinetic analysis

“…The same dosage and administration schedule developed in Europe and the United States is also employed in Japan, and the drug is expected to be highly useful as outpatient treatment for mild and moderate community-acquired pneumonia. Although the results of many clinical studies have been reported in other countries [1][2][3][4][5], few studies on patients with respiratory infection have been performed in Japan, and to our knowledge, only two domestic clinical studies have been reported [6,7]. Also, detailed evaluation of the pharmacokinetics of MFLX has not been conducted in Japanese patients with community-acquired pneumonia.…”

Fluoroquinolones or macrolides alone versus combined with β-lactams for adults with community-acquired pneumonia: Systematic review and meta-analysis

“…After further excluding duplicate publications ( Fig. 1), 16 RCTs fulfilling the inclusion criteria were included [5][6][7][8][9][10][11][12][13][14][15][16][17][18][19][20] Two were published only as conference proceedings and contact with the authors could not be established [6,13].…”

What Is New in Antibiotic Therapy in Community-Acquired Pneumonia? An Evidence-Based Approach Focusing on Combined Therapy

“…No differences in mortality or an increased eradication rate in the fluoroquinolone arm were found when comparing a fluoroquinolone versus a beta-lactam plus a macrolide [25][26][27]. One clinical trial by Torres et al [24] did not observe differences in mortality after comparing moxifloxacin monotherapy with ceftriaxone plus levofloxacin in a cohort of CAP patients including 10 % with severe pneumonia (PSI score IV or V). Thirteen observational studies were identified.…”