Trial intelligence / Profile preview

Levofloxacin vs Ciprofloxacin in Complicated UTI

NCT00258089Phase 3

Key facts

Status
Completed
Start
Jun 1993
Modality
Small Molecules
Conditions
complicated urinary tract infection (cUTI)
01

Overview

Phase 3, randomised, double-blind trial of levofloxacin in complicated urinary tract infection (cUTI) (2 arms), sponsored by Johnson & Johnson. Primary endpoints: Clinical Response and Microbiological Response. Started Jun 1993; status: completed.

02

Design

2 arms
Study design
RandomizedDouble-blind
  • Levofloxacin

    Levofloxacin 250 mg QD + Placebo

  • Ciprofloxacin

    Ciprofloxacin 500 mg BID + Placebo

03

Who it enrols

Adults with complicated urinary tract infections capable of taking oral medication. Excludes patients requiring IV therapy, with complete urinary obstruction, prostate inflammation, or pregnancy.

04

Endpoints

Primary

  • Clinical Response

  • Microbiological Response

Secondary

  • Overall Clinical Response

  • Incidence of Adverse Events

  • Change in Clinical Laboratory Tests

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