Cefepime/AAI101 Phase 2 Study in Hospitalized Adults With cUTI
Cefepime/AAI101 Phase 2 Study in Hospitalized Adults With cUTI
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.
Inclusion criteria:

 • Male or female patients with clinical signs and/or symptoms of cUTI or acute
 pyelonephritis that were expected to require hospitalization and initial treatment with at
 least 7 days of i.v.

 antibiotics.

 Exclusion criteria:

 -  Patients with concurrent infection that would interfere with evaluation of response to
 the study antibiotics;

 -  Patients needing concomitant systemic antimicrobial agents in addition to those
 designated in the various study treatment groups;

 -  Patients receiving effective antibacterial drug therapy for any indication for a
 continuous duration of >24 hours during the previous 72 hours before the
 study-qualifying baseline urine was obtained or receiving any amount of potentially
 therapeutic antibacterial therapy after collection of the pre-treatment baseline urine
 culture and before administration of the first dose of study drug;

 -  Patients likely to require the use of an antibiotic for cUTI or acute pyelonephritis
 prophylaxis during participation in the study;

 -  Patients with confirmed fungal urinary tract infection at the screening visit (with
 ≥103 fungal colony forming units [CFU]/mL); or

 -  Patients with intractable urinary infection at baseline that the Investigator
 anticipated would require >10 days of study drug therapy were excluded from
 participation