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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
Ist Teil von
International journal of antimicrobial agents, 2004-03, Vol.23, p.41-53
Ort / Verlag
London: Elsevier B.V
Erscheinungsjahr
2004
Quelle
Access via ScienceDirect (Elsevier)
Beschreibungen/Notizen
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.