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, -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:
|
Authors | Antoni 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 |
Journal | Clinical 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 |
PMID | 18419482
(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
|