Cefepime/AAI101 Phase 2 Study in Hospitalized Adults With cUTI

NCT03680612 | Completed Phase 2

• 1 other identifier: AT-201
• Study Type: interventional
• Target: 45
• Locations: 5 countries
• Sites: 5

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.

Conditions

Urinary Tract Infections

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Microbiological Response at the TOC Visit in the Microbiologically Evaluable (ME) Population.

  6 to 9 days post-End of Treatment

Study Arms (2)

Cefepime 1G - 2G / AAI101 0.5G - 0.75G

EXPERIMENTAL

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

cefepime monotherapy

ACTIVE COMPARATOR

cefepime 1 g or cefepime 2 g

Drug: cefepime 1 g or cefepime 2 g

Interventions

Cefepime 1G - 2G / AAI101 0.5G - 0.75G DRUG

Experimental drug

Also known as: cefepime/AAI101 combination

Cefepime 1G - 2G / AAI101 0.5G - 0.75G

cefepime 1 g or cefepime 2 g DRUG

cefepime monotherapy

Also known as: cefepime alone

cefepime monotherapy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Allecra: lead
• Medpace, Inc.: collaborator

Study Sites (5)

Kromerizska nemocnice

Kroměříž, 76701, Czechia

Location

Jahn Ferenc Del-pesti Korhaz

Budapest, 1204, Hungary

Location

Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji w Warszawie, Klinika Chorob Wewnetrznych, Nefrologii i Transplantologii

Warsaw, 02-507, Poland

Location

Fakultna nemocnica s poliklinikou J.A. Reimana Presov

Prešov, 081 81, Slovakia

Location

Chernihiv City Hospital #2 of Chernihiv City Council, department of Urology

Chernihiv, 14034, Ukraine

Location

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

Cefepime; enmetazobactam

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2018
• First Posted: September 21, 2018
• Study Start: September 5, 2017
• Primary Completion: February 14, 2018
• Study Completion: February 14, 2018
• Last Updated: September 21, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

UA (1); PL (1); CZ (1); SL (1); HU (1)