Multicenter evaluation of the efficacy and safety of gatifloxacin in Mexican adult outpatients with respiratory tract infections.
Respiratory tract infections (RTIs), the most common indication for outpatient antimicrobial therapy, impose a heavy medical and societal burden and present a difficult therapeutic challenge in the face of increasing pathogen resistance worldwide. Gatifloxacin is a new broad-spectrum fluoroquinolone with excellent activity against prevalent respiratory bacteria, including penicillin-resistant Streptococcus pneumoniae and atypical pathogens. A multicenter, open-label, noncomparative surveillance study carried out in Mexico evaluated the safety and efficacy of oral gatifloxacin 400 mg once daily in 17,923 adult outpatients with community-acquired pneumonia (CAP) (n = 3322), acute exacerbations of chronic bronchitis (AECB) (n = 5885), and acute bacterial sinusitis (n = 8716). Voluntary, unpaid physician participation contributed to an unbiased study design. Physician-assessed global rate of cure or improvement was 96.3%; efficacy was 95.8% in CAP, 96.1% in AECB, and 96.4% in sinusitis. The incidences of relapse (1.5%) and therapeutic failure (0.7%) were low. The most commonly reported adverse events, nausea (2.76%), headache (2.20%), and dizziness (1.33%), were generally mild and self-limited. Oral gatifloxacin 400 mg once daily is effective and safe for patients with CAP, AECB, and acute sinusitis.
Casillas
J L
JL
Hospital de Especialidades Miguel Hidalgo Aguascalientes, AGS, Mexico.
Rico
G
G
Rodríguez-Parga
D
D
Mascareño
A
A
Rangel-Frausto
S
S
D000208:Acute Disease; D000284:Administration, Oral; D000328:Adult; D000553:Ambulatory Care / Q000379:methods*; D000890:Anti-Infective Agents / Q000627:therapeutic use*; D001424:Bacterial Infections / Q000188:drug therapy* / Q000382:microbiology; D001991:Bronchitis / Q000188:drug therapy* / Q000382:microbiology; D017714:Community-Acquired Infections / Q000188:drug therapy* / Q000382:microbiology; D004244:Dizziness / Q000139:chemically induced; D004352:Drug Resistance, Microbial; D005260:Female; D024841:Fluoroquinolones; D000077734:Gatifloxacin; D006261:Headache / Q000139:chemically induced; D006801:Humans; D008297:Male; D008800:Mexico; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D011014:Pneumonia / Q000188:drug therapy* / Q000382:microbiology; D011446:Prospective Studies; D012008:Recurrence; D012141:Respiratory Tract Infections / Q000188:drug therapy* / Q000382:microbiology; D012449:Safety; D012852:Sinusitis / Q000188:drug therapy* / Q000382:microbiology; D016896:Treatment Outcome
D000890:Anti-Infective Agents; D024841:Fluoroquinolones; D000077734:Gatifloxacin