Cefepime/AAI101 Phase 2 Study in Hospitalized Adults With cUTI

Urinary Tract Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03680612
• Other study ID #: AT-201
• Status: Completed
• Phase: Phase 2
• Start date: September 5, 2017
• Est. completion date: February 14, 2018

Study information

• Verified date: September 2018
• Source: Allecra
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: February 14, 2018
• Est. primary completion date: February 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Infection
• Urinary Tract Infections

Intervention

Drug:
• Cefepime 1G - 2G / AAI101 0.5G - 0.75G
Experimental drug
• cefepime 1 g or cefepime 2 g
cefepime monotherapy

Locations

Country	Name	City	State
Czechia	Kromerizska nemocnice	Kromeriz
Hungary	Jahn Ferenc Del-pesti Korhaz	Budapest
Poland	Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji w Warszawie, Klinika Chorob Wewnetrznych, Nefrologii i Transplantologii	Warsaw
Slovakia	Fakultna nemocnica s poliklinikou J.A. Reimana Presov	Prešov
Ukraine	Chernihiv City Hospital #2 of Chernihiv City Council, department of Urology	Chernihiv

Sponsors (2)

Lead Sponsor	Collaborator
Allecra	Medpace, Inc.

Countries where clinical trial is conducted

Czechia,  Hungary,  Poland,  Slovakia,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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