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Moxifloxacin monotherapy is effective in hospitalized patients with community-acquired pneumonia: the MOTIV study--a randomized clinical trial.

AbstractBACKGROUND:
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.
AuthorsAntoni Torres, Javier Garau, Pierre Arvis, Jean Carlet, Shurjeel Choudhri, Amar Kureishi, Marie-Aude Le Berre, Hartmut Lode, John Winter, Robert C Read, MOTIV (MOxifloxacin Treatment IV) Study Group
JournalClinical infectious diseases : an official publication of the Infectious Diseases Society of America (Clin Infect Dis) Vol. 46 Issue 10 Pg. 1499-509 (May 15 2008) ISSN: 1537-6591 [Electronic] United States
PMID18419482 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Anti-Bacterial Agents
  • Aza Compounds
  • Fluoroquinolones
  • Quinolines
  • Levofloxacin
  • Ceftriaxone
  • Ofloxacin
  • Moxifloxacin
Topics
  • Aged
  • Aged, 80 and over
  • Anti-Bacterial Agents (administration & dosage, adverse effects, therapeutic use)
  • Aza Compounds (administration & dosage, adverse effects, therapeutic use)
  • Bacteria (isolation & purification)
  • Ceftriaxone (administration & dosage, adverse effects, therapeutic use)
  • Community-Acquired Infections (drug therapy, mortality)
  • Double-Blind Method
  • Drug Therapy, Combination
  • Female
  • Fluoroquinolones
  • Humans
  • Levofloxacin
  • Male
  • Middle Aged
  • Moxifloxacin
  • Ofloxacin (administration & dosage, adverse effects, therapeutic use)
  • Pneumonia, Bacterial (drug therapy, mortality)
  • Prospective Studies
  • Quinolines (administration & dosage, adverse effects, therapeutic use)
  • Severity of Illness Index
  • Treatment Outcome

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