Gatifloxacin 200 mg or 400 mg once daily is as effective as ciprofloxacin 500 mg twice daily for the treatment of patients with acute pyelonephritis or complicated urinary tract infections.
The efficacy and safety of two oral dosing regimens of gatifloxacin were compared to ciprofloxacin in the treatment of complicated urinary tract infection in a randomised, double-blind multi-centre trial. One thousand one hundred and twenty-three adult patients with complicated urinary tract infection (70%) or pyelonephritis (30%) were initially enrolled, 1122 were treated. Of these, 824 were included in a modified ITT population: gatifloxacin 200 mg (274 patients) or 400 mg (280 patients) once daily or ciprofloxacin 500 mg twice daily for 5-14 days (269 patients). Bacteriological and clinical responses were assessed 7-9 days after the end of treatment (EOT) and 4-6 weeks post-treatment (end of study visit, EOS). The bacteriological response rates per patient at EOT in the gatifloxacin 400 mg, gatifloxacin 200 mg and ciprofloxacin groups were 77% (207/269), 78% (208/268) and 73% (190/259), respectively. At EOS they were slightly lower: 70% (184/262), 71% (176/248) and 69% (174/252), respectively. The clinical responses at EOT were 69% (190/277), 70% (190/273) and 65% (174/266). At EOS they were 71% (193/273), 70% (182/259) and 74% (190/258). The overall eradication rates of initial pathogens at EOT and EOS were 85.3% and 88.4% in the gatifloxacin 400 mg group; 84.1 and 90.1% in the gatifloxacin 200 mg group and 85.1 and 91.4% in the ciprofloxacin group. Both oral regimens of gatifloxacin were as effective as that of ciprofloxacin. All treatment groups showed a similar safety profile, nausea being the most frequently reported adverse event.
Naber
K G
KG
Klinikum St. Elisabeth Straubing, Akademisches Lehrkrankenhaus TU München-Urologische Klinik, St Elisabeth-Strasse 23, 94315 Straubing, Germany. naberk@klinikum-straubing.de
Bartnicki
A
A
Bischoff
W
W
Hanus
M
M
Milutinovic
S
S
van Belle
F
F
Schönwald
S
S
Weitz
P
P
Ankel-Fuchs
D
D
D001424:Bacterial Infections / Q000145:classification / Q000188:drug therapy*; D002939:Ciprofloxacin / Q000008:administration & dosage / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D024841:Fluoroquinolones / Q000008:administration & dosage / Q000627:therapeutic use*; D000077734:Gatifloxacin; D006801:Humans; D008297:Male; D008875:Middle Aged; D011704:Pyelonephritis / Q000188:drug therapy*; D016896:Treatment Outcome; D014552:Urinary Tract Infections / Q000188:drug therapy*
D024841:Fluoroquinolones; D002939:Ciprofloxacin; D000077734:Gatifloxacin