Cefepime/AAI101 Phase 2 Study in Hospitalized Adults With cUTI

NCT ID: NCT03680612

Last Updated: 2018-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-05
• Study Completion Date: 2018-02-14

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

cefepime 1 g or cefepime 2 g in combination with AAI101 500 mg or 750 mg

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

Experimental drug

cefepime monotherapy

cefepime 1 g or cefepime 2 g

Group Type: ACTIVE_COMPARATOR

cefepime 1 g or cefepime 2 g

Intervention Type: DRUG

cefepime monotherapy

Interventions

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

Experimental drug

Intervention Type: DRUG

cefepime 1 g or cefepime 2 g

cefepime monotherapy

Intervention Type: DRUG

Other Intervention Names

cefepime/AAI101 combination; cefepime alone

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medpace, Inc.

INDUSTRY

Sponsor Role: collaborator

Allecra

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Kromerizska nemocnice

Kroměříž, , Czechia

Jahn Ferenc Del-pesti Korhaz

Budapest, , Hungary

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

Warsaw, , Poland

Fakultna nemocnica s poliklinikou J.A. Reimana Presov

Prešov, , Slovakia

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

Chernihiv, , Ukraine

Countries

Czechia; Hungary; Poland; Slovakia; Ukraine

Other Identifiers

AT-201

Identifier Type: -

Identifier Source: org_study_id