title: Efficacy and safety of moxifloxacin in community acquired pneumonia: a prospective, multicenter, observational study (CAPRIVI).
abstract: BACKGROUND
  Community acquired pneumonia (CAP) is a major cause of morbidity, hospitalization, and mortality worldwide. Management of CAP for many patients requires rapid initiation of empirical antibiotic treatment, based on the spectrum of activity of available antimicrobial agents and evidence on local antibiotic resistance. Few data exist on the severity profile and treatment of hospitalized CAP patients in Eastern and Central Europe and the Middle East, in particular on use of moxifloxacin (Avelox®), which is approved in these regions.
  
  
  METHODS
  CAPRIVI (Community Acquired Pneumonia: tReatment wIth AVelox® in hospItalized patients) was a prospective observational study in 12 countries: Croatia, France, Hungary, Kazakhstan, Jordan, Kyrgyzstan, Lebanon, Republic of Moldova, Romania, Russia, Ukraine, and Macedonia. Patients aged >18 years were treated with moxifloxacin 400 mg daily following hospitalization with a CAP diagnosis. In addition to efficacy and safety outcomes, data were collected on patient history and disease severity measured by CRB-65 score.
  
  
  RESULTS
  2733 patients were enrolled. A low severity index (i.e., CRB-65 score <2) was reported in 87.5% of CAP patients assessed (n=1847), an unexpectedly high proportion for hospitalized patients. Moxifloxacin administered for a mean of 10.0 days (range: 2.0 to 39.0 days) was highly effective: 96.7% of patients in the efficacy population (n=2152) improved and 93.2% were cured of infection during the study. Severity of infection changed from "moderate" or "severe" in 91.8% of patients at baseline to "no infection" or "mild" in 95.5% at last visit. In the safety population (n=2595), 127 (4.9%) patients had treatment-emergent adverse events (TEAEs) and 40 (1.54%) patients had serious TEAEs; none of these 40 patients died. The safety results were consistent with the known profile of moxifloxacin.
  
  
  CONCLUSIONS
  The efficacy and safety profiles of moxifloxacin at the recommended dose of 400 mg daily are characterized in this large observational study of hospitalized CAP patients from Eastern and Central Europe and the Middle East. The high response rate in this study, which included patients with a range of disease severities, suggests that treatment with broader-spectrum drugs such as moxifloxacin is appropriate for patients with CAP who are managed in hospital.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier: NCT00987792.
authors: University of Zagreb School of Medicine, University Hospital for Infectious Diseases "Dr, Fran Mihaljević", Mirogojska cesta 8, 10000 Zagreb, Croatia. ilijakuzman@net.hr.
authors: Ilija
authors: I
authors: Kuzman
authors: Alexandr
authors: A
authors: Bezlepko
authors: Irena
authors: I
authors: Kondova Topuzovska
authors: László
authors: L
authors: Rókusz
authors: Liudmyla
authors: L
authors: Iudina
authors: Hans-Peter
authors: HP
authors: Marschall
authors: Thomas
authors: T
authors: Petri
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000627:therapeutic use*; D017714:Community-Acquired Infections / Q000175:diagnosis / Q000188:drug therapy; D005061:Europe, Eastern; D005260:Female; D024841:Fluoroquinolones / Q000009:adverse effects / Q000627:therapeutic use*; D005602:France; D006760:Hospitalization; D006801:Humans; D007623:Kazakhstan; D007707:Kyrgyzstan; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D008877:Middle East; D000077266:Moxifloxacin; D011014:Pneumonia / Q000175:diagnosis / Q000188:drug therapy*; D011446:Prospective Studies; D012720:Severity of Illness Index; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D024841:Fluoroquinolones; D000077266:Moxifloxacin