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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 2

Contacts and Locations

Study Locations

• Czechia
  • Kromeriz, Czechia, 76701
    • Kromerizska nemocnice
• Hungary
  • Budapest, Hungary, 1204
    • Jahn Ferenc Dél-Pesti Kórház
• Poland
  • Warsaw, Poland, 02-507
    • Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji w Warszawie, Klinika Chorob Wewnetrznych, Nefrologii i Transplantologii
• Slovakia
  • Prešov, Slovakia, 081 81
    • Fakultna nemocnica s poliklinikou J.A. Reimana Presov
• Ukraine
  • Chernihiv, Ukraine, 14034
    • Chernihiv City Hospital #2 of Chernihiv City Council, department of Urology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Cefepime 1G - 2G / AAI101 0.5G - 0.75G; cefepime 1 g or cefepime 2 g in combination with AAI101 500 mg or 750 mg	Drug: Cefepime 1G - 2G / AAI101 0.5G - 0.75G; Experimental drug; Other Names: cefepime/AAI101 combination
ACTIVE_COMPARATOR: cefepime monotherapy; cefepime 1 g or cefepime 2 g	Drug: cefepime 1 g or cefepime 2 g; cefepime monotherapy; Other Names: cefepime alone

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Allecra
• Collaborators: Medpace, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 5, 2017
• Primary Completion (ACTUAL): February 14, 2018
• Study Completion (ACTUAL): February 14, 2018

Study Registration Dates

• First Submitted: September 19, 2018
• First Submitted That Met QC Criteria: September 20, 2018
• First Posted (ACTUAL): September 21, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 21, 2018
• Last Update Submitted That Met QC Criteria: September 20, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Infections; Urinary Tract Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; beta-Lactamase Inhibitors; Cefepime; Enmetazobactam
• Other Study ID Numbers: AT-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No