Once daily, levofloxacin 750 mg for 5 days in the treatment of acute pyelonephritis and associated bacteraemia
Abstract number: 1732_86
Brown P., Peterson J., Khashab M., Kaul S., Fisher A., Kahn J.
Objective: Urinary tract infections, in particular, pyelonephritis, have been identified as a common cause of Gram-negative bacteraemia. Studies that evaluated the prevalence of positive blood cultures in acute pyelonephritis (AP) yielded a blood pathogen in up to 23% of patients. The current clinical study represents one of the largest cohorts of patients with AP studied to date and provides an opportunity to assess the incidence, clinical presentation and outcome of bacteraemia in patients with AP.
Methods: This was a randomised, double-blind study. Subjects >18 yrs were stratified depending on diagnosis (cUTI or AP), residence, and catheter status. Subjects were randomised to treatment with iv/oral levofloxacin (levo) 750 mg qd, 5d or iv/oral ciprofloxacin (cipro) 400/500 mg bid, 10d. Blood cultures were obtained at study entry and, if positive, again at Posttherapy.
Results: 1109 subjects were enrolled; 1093 were randomised and received >1 dose of study drug; 619 had a confirmed clinical diagnosis and a study entry uropathogen (modified intent-to-treat [mITT] population). 192 mITT subjects were diagnosed with AP. Urine eradication rates for subjects with AP were 86.2% (81/94) for levo and 80.6% (79/98) for cipro (95% CI: -16.0, 4.9). 23 AP subjects (11 levo, 12 cipro) had a positive blood culture at study entry. 5 of the 23 subjects were hospitalised. All blood cultures identified E. coli. One cipro-resistant isolate (MIC > 32) was isolated from a cipro-treated subject. 9 levo subjects were clinical successes, 2 were failures. With cipro, 7 subjects were clinical successes, 2 were failures and for 3, the outcome was unknown. The urine pathogen was eradicated in 10 and was unknown for 1 levo subject compared to eradicated in 7, persisted in 3, and unknown in 2 cipro-treated subjects. A repeat blood culture was obtained for 7 levo and 8 cipro subjects, with the blood pathogen eradicated in all subjects. For one other cipro-treated subject, the blood pathogen was presumed persisted based on clinical failure. The outcome for the cipro-resitant E. coli was unknown.
Conclusions: For the overall population (cUTI and AP) and for the cUTI and AP cohorts. 5 doses of levo were non-inferior to 20 doses of cipro. Levo and cipro eradicated blood pathogens in all subjects who had a 2nd blood culture.
|Session name:||European Society of Clinical Microbiology and Infectious Diseases|
|Location:||ICC, Munich, Germany|
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