Urinary Tract Infections Clinical Trial
Official title:
Randomized, Double-Blind, Multi-Center Study of Cefepime/AAI101 in Hospitalized Adults With Complicated Urinary Tract Infections, Including Acute Pyelonephritis
Phase 2, randomised, double-blind, 2-cohort study in hospitalised adults with complicated
urinary tract infection (cUTI), including acute pyelonephritis. All study cohorts were
randomised in a 2:1 ratio. Treatment duration for each cohort was 7 to 10 days. Patients were
not permitted to switch to oral therapy.
Cohort 1: 15 patients treated with cefepime 1 g/AAI101 500 mg intravenous (i.v.) infusion
over 2 hours once every 8 hours (q8h), and 7 patients treated with cefepime 1 g i.v. infusion
over 2 hours q8h.
Cohort 2: 15 patients treated with cefepime 2 g/AAI101 750 mg i.v. infusion over 2 hours q8h,
and 8 patients treated with cefepime 2 g i.v. infusion over 2 hours q8h.
n/a
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