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Ceftolozane-tazobactam compared with levofloxacin in the treatment of complicated urinary-tract infections, including pyelonephritis: a randomised, double-blind, phase 3 trial (ASPECT-cUTI).
Wagenlehner, Florian M; Umeh, Obiamiwe; Steenbergen, Judith; Yuan, Guojun; Darouiche, Rabih O.
Afiliação
  • Wagenlehner FM; Clinic for Urology, Paediatric Urology and Andrology, Justus-Liebig University, Giessen, Germany. Electronic address: florian.wagenlehner@chiru.med.uni-giessen.de.
  • Umeh O; Cubist Pharmaceuticals, Lexington, MA, USA.
  • Steenbergen J; Cubist Pharmaceuticals, Lexington, MA, USA.
  • Yuan G; Cubist Pharmaceuticals, Lexington, MA, USA.
  • Darouiche RO; Michael E DeBakey Veterans Affairs Medical Center and Baylor College of Medicine, Houston, TX, USA.
Lancet ; 385(9981): 1949-56, 2015 May 16.
Article em En | MEDLINE | ID: mdl-25931244
BACKGROUND: Treatment of complicated urinary-tract infections is challenging due to rising antimicrobial resistance. We assessed the efficacy and safety of ceftolozane-tazobactam, a novel antibacterial with Gram-negative activity, in the treatment of patients with complicated lower-urinary-tract infections or pyelonephritis. METHODS: ASPECT-cUTI was a randomised, double-blind, double-dummy, non-inferiority trial done in 209 centres in 25 countries. Between July, 2011, and September, 2013, hospital inpatients aged 18 years or older who had pyuria and a diagnosis of a complicated lower-urinary-tract infection or pyelonephritis were randomly assigned in a 1:1 ratio to receive intravenous 1·5 g ceftolozane-tazobactam every 8 h or intravenous high-dose (750 mg) levofloxacin once daily for 7 days. The randomisation schedule was computer generated in blocks of four and stratified by study site. The next allocation was obtained by the study site pharmacist via an interactive voice-response system. The primary endpoint was a composite of microbiological eradication and clinical cure 5-9 days after treatment in the microbiological modified intention-to-treat (MITT) population, with a non-inferiority margin of 10%. This study is registered with ClinicalTrials.gov, numbers NCT01345929 and NCT01345955. FINDINGS: Of 1083 patients enrolled, 800 (73·9%), of whom 656 (82·0%) had pyelonephritis, were included in the microbiological MITT population. Ceftolozane-tazobactam was non-inferior to levofloxacin for composite cure (306 [76·9%] of 398 vs 275 [68·4%] of 402, 95% CI 2·3-14·6) and, as the lower bound of the two-sided 95% CI around the treatment difference was positive and greater than zero, superiority was indicated. Adverse event profiles were similar in the two treatment groups and were mainly non-serious. INTERPRETATION: Treatment with ceftolozane-tazobactam led to better responses than high-dose levofloxacin in patients with complicated lower-urinary-tract infections or pyelonephritis. FUNDING: Cubist Pharmaceuticals.
Assuntos

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Infecções Urinárias / Cefalosporinas / Infecções por Bactérias Gram-Positivas / Infecções por Bactérias Gram-Negativas / Ácido Penicilânico / Levofloxacino / Anti-Infecciosos Urinários Tipo de estudo: Clinical_trials Limite: Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Ano de publicação: 2015 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Infecções Urinárias / Cefalosporinas / Infecções por Bactérias Gram-Positivas / Infecções por Bactérias Gram-Negativas / Ácido Penicilânico / Levofloxacino / Anti-Infecciosos Urinários Tipo de estudo: Clinical_trials Limite: Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Ano de publicação: 2015 Tipo de documento: Article