Cefepime/AAI101 Phase 2 Study in Hospitalized Adults With cUTI

Phase 2

Completed

• Conditions: Urinary Tract Infections
• Interventions: Drug: Cefepime 1G - 2G / AAI101 0.5G - 0.75G; Drug: cefepime 1 g or cefepime 2 g

• Registration Number: NCT03680612
• Lead Sponsor: Allecra

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-05
• Primary Completion: 2018-02-14
• Study Completion: 2018-02-14
• Status Verified: 2018-09
• Study First Submitted: 2018-09-19
• Study First Submitted QC: 2018-09-20
• Last Update Submitted: 2018-09-20
• Study First Posted: 2018-09-21
• Last Update Posted: 2018-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cefepime 1G - 2G / AAI101 0.5G - 0.75G	Cefepime 1G - 2G / AAI101 0.5G - 0.75G	cefepime 1 g or cefepime 2 g in combination with AAI101 500 mg or 750 mg
cefepime monotherapy	cefepime 1 g or cefepime 2 g	cefepime 1 g or cefepime 2 g

Primary Outcome Measures

Name	Time	Method
Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-Treat (mMITT) Population	6 to 9 days post-End of Treatment	Microbiological response is eradication for each baseline pathogen

Secondary Outcome Measures

Name	Time	Method
Microbiological Response at the TOC Visit in the Microbiologically Evaluable (ME) Population.	6 to 9 days post-End of Treatment	Microbiological response is eradication for each baseline pathogen

Trial Locations

Locations (5)

Chernihiv City Hospital #2 of Chernihiv City Council, department of Urology; 🇺🇦 Chernihiv, Ukraine

Fakultna nemocnica s poliklinikou J.A. Reimana Presov; 🇸🇰 Prešov, Slovakia

Jahn Ferenc Del-pesti Korhaz; 🇭🇺 Budapest, Hungary

Kromerizska nemocnice; 🇨🇿 Kromeriz, Czechia

Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji w Warszawie, Klinika Chorob Wewnetrznych, Nefrologii i Transplantologii; 🇵🇱 Warsaw, Poland