NCT03680612

Cefepime/AAI101 Phase 2 Study in Hospitalized Adults With cUTI

Randomized, Double-Blind, Multi-Center Study of Cefepime/AAI101 in Hospitalized Adults With Complicated Urinary Tract Infections, Including Acute Pyelonephritis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Allecra · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Urinary Tract Infections

Interventions

Type	Name	Description
DRUG	Cefepime 1G - 2G / AAI101 0.5G - 0.75G	Experimental drug
DRUG	cefepime 1 g or cefepime 2 g	cefepime monotherapy

Timeline

• Start date: 2017-09-05
• Primary completion: 2018-02-14
• Completion: 2018-02-14
• First posted: 2018-09-21
• Last updated: 2018-09-21

Locations

5 sites across 5 countries: Czechia, Hungary, Poland, Slovakia, Ukraine