Oral vs intravenous ciprofloxacin in the initial empirical management of severe pyelonephritis or complicated urinary tract infections - A prospective randomized clinical trial

Background: There are few data on the efficacy of oral antibiotics in the i nitial empirical management of severe forms of urinary tract infection (UTI ). Methods: In a multicenter, prospective, randomized trial we compared oral ( 500 mg twice daily) vs intravenous ciprofloxacin (200 mg twice daily) in th e initial empirical management of hospitalized patients with serious forms of UTI. Exclusion criteria were severe sepsis, inability to take oral medic ation, or the presence of obstruction or renal foci of suppuration. The stu dy population included 66 women with pyelonephritis, 43 patients with commu nity-acquired UTIs, and 32 patients with hospital-acquired UTIs. The freque ncy of bacteremia was 28 (42%) of 66 in the patients with pyelonephritis an d 25 (33%) of 75 in those with complicated UTIs. Seventy-two patients were randomized to treatment with oral and 69 to intravenous ciprofloxacin. Results: There were no infection-related deaths and no patients required an early change of antibiotics because of worsening clinical status during th e initial empirical phase of treatment. The mean duration of fever was 1.7 days in patients treated by the oral vs 1.9 days in patients treated by the intravenous route (P = .15). The rates of microbiological failure (3% in t he oral vs 2% in the intravenous treatment group) and of unsatisfactory cli nical response (4% oral vs 3% intravenous) were low. A treatment change was eventually required in 14% of the patients assigned to the oral and 7% of the patients assigned to the intravenous regimen, mainly because of the iso lation of enterococci or ciprofloxacin-resistant organisms in pretherapy ur ine specimens. Conclusions: In the hospital setting, oral ciprofloxacin is as effective as the intravenous regimen in the initial empirical management of serious UTI s, including bacteremic forms, in patients without severe sepsis, obstructi on, or renal foci of suppuration. The efficacy of the oral regimen indicate s a potential use for ciprofloxacin in outpatient treatment of a subset of patients currently hospitalized on account of disease severity.