Randomised double-blind comparison of oral gatifloxacin and co-amoxiclav for acute exacerbation of chronic Bronchitis.
Antimicrobial therapy can have a significant impact in the treatment of acute infectious exacerbations in patients with chronic bronchitis, in whom repeated episodes are common. The aim of this randomised, double-blind, double-dummy, parallel group study was to compare the efficacy and safety of oral gatifloxacin (200 and 400 mg once daily) administered for 5 days with co-amoxiclav (500 mg amoxicillin/125 mg clavulanic acid t.i.d.) administered for 10 days in 414 adult patients with acute exacerbation of chronic bronchitis. Overall clinical response rates (cure plus improvement) were 86.2%, 79.4% and 81.7% in the gatifloxacin 200 mg, gatifloxacin 400 mg and co-amoxiclav groups, respectively, and the equivalence hypothesis used for statistical analysis showed equivalent efficacy for both gatifloxacin 200 and 400 mg compared to co-amoxiclav. The same was true for rates of bacterial response, with eradication or presumed eradication of causative pathogens achieved in 87.5%, 87.3% and 79.1% of cases in the gatifloxacin 200 mg, gatifloxacin 400 mg and co-amoxiclav groups, respectively. All treatments were well tolerated, with the nature and frequency of treatment-related adverse events similar in all groups. The results of the study show that gatifloxacin is a safe and effective agent for the treatment of patients with chronic bronchitis experiencing an acute infectious exacerbation.
Solèr
M
M
Department of Chest Diseases, Kantonsspital Basel, Petersgraben 4, 4031, Basel, Switzerland. markus.soler@claraspital.ch
Lode
H
H
Baldwin
R
R
Levine
J H A
JH
Schreurs
A J M
AJ
van Noord
J A
JA
Maesen
F P V
FP
Zehrer
M
M
D000284:Administration, Oral; D019980:Amoxicillin-Potassium Clavulanate Combination / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000890:Anti-Infective Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001419:Bacteria / Q000145:classification / Q000302:isolation & purification; D001424:Bacterial Infections / Q000188:drug therapy; D029481:Bronchitis, Chronic / Q000188:drug therapy* / Q000382:microbiology; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D024841:Fluoroquinolones; D000077734:Gatifloxacin; D006801:Humans; D008297:Male; D010313:Partial Pressure; D016896:Treatment Outcome; D014797:Vital Capacity
D000890:Anti-Infective Agents; D024841:Fluoroquinolones; D019980:Amoxicillin-Potassium Clavulanate Combination; D000077734:Gatifloxacin