Study of Cefepime-zidebactam (FEP-ZID) in Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)

Wockhardt530 enrolled

Overview

This is a Phase 3, randomized, double-blind, multicenter, non-inferiority study to evaluate the efficacy, safety, and tolerability of FEP-ZID vs. meropenem in the treatment of hospitalized adults with cUTI or AP. Approximately 528 hospitalized adult subjects (≥ 18 years of age) diagnosed with cUTI or AP will be enrolled in the study. The diagnosis of cUTI or AP will be based on a combination of clinical symptoms and signs plus the presence of pyuria. The total duration of treatment with study drug is 7 to 10 days. Each subject must remain hospitalized during the study drug treatment period; no outpatient parenteral antibiotic therapy is allowed.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

530

Conditions

Complicated Urinary Tract Infection Acute Pyelonephritis

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Male or female ≥ 18 years of age 2. Provide a signed written informed consent prior to any study-specific procedures 3. Meet the clinical criteria for either cUTI or AP 4. Requires hospitalization to manage the cUTI or AP 5. Agrees to use effective methods of contraception Exclusion Criteria: 1. Known or suspected disease that may confound the assessment of efficacy. 2. Receipt of more than 72 hours of prior antibiotic therapy except for those failing prior antibiotic therapy and/or having documented uropathogen resistant to the prior therapy. 3. Rapidly progressive illness such that the subject is unlikely to survive the study period. 4. Pregnant or breastfeeding women 5. History of a seizure disorder requiring current treatment 6. Creatinine clearance \< 15 mL/min or on renal dialysis 7. Neutropenia or elevated liver enzymes 8. Hypersensitivity to beta-lactam antibiotics 9. Unlikely to comply with the protocol or the Investigator considers that study participation may not be optimal for the subject

Locations (48)

S&D Clinical Research, LLC

Fort Myers, Florida, United States

Santos Research Center

Tampa, Florida, United States

MHAT Dobrich AD

Dobrich, Bulgaria

UMHAT Dr. Georgi Stranski

Pleven, Bulgaria

Multiprofile Hospital for Active Treatment - Plovdiv AD, Plovdiv

Plovdiv, Bulgaria

Multiprofile Hospital for Active Treatment - KANEV

Outcomes

Primary Outcomes

Percentage of subjects with overall success at Test-of-Cure

Overall success is defined as complete resolution of cUTI or AP symptoms present at study entry (or return to premorbid state) and no new cUTI or AP symptoms together with microbiologic eradication of the bacterial pathogen found at study entry (reduced to \<1000 colony forming units or CFU/mL)

Time frame: Test Of Cure Visit (Day 17 ± 2 days)

Percentage of subjects with Treatment-Emergent Adverse Events (TEAE)

Collection of number of adverse events.

Time frame: Day 1 to the end of study Late Follow-Up visit (LFU) (26 ± 2 days)]

Secondary Outcomes

Percentage of subjects with overall success at End-of-Treatment

Time frame: End of Treatment Visit (Day 7 - 10 ± 1 day)

Percentage of subjects with clinical cure at End-of-Treatment

Clinical cure is defined as complete resolution of cUTI or AP symptoms present at study entry (or return to premorbid state) and no new cUTI or AP symptoms together with microbiologic eradication of the bacterial pathogen found at study entry (reduced to \<1000 CFU/mL)(CFU)/mL.

Time frame: End of Treatment Visit (Day 7 - 10 ± 1 day)

Percent of subjects with microbiological eradication at End-of-Treatment

Microbiologic eradication is defined as demonstrating \<1000 CFU/mL of the bacterial pathogen found at study entry

Time frame: End of Treatment Visit (Day 7 - 10 ± 1 day)

Percentage of subjects with clinical cure at Test-of-Cure

Time frame: End of Treatment Visit (Day 17 ± 2 days)

Percent of subjects with microbiological eradication at Test-of-Cure

Microbiologic eradication is defined as demonstrating \<1000 CFU/mL of the bacterial

Time frame: End of Treatment Visit (Day 17 ± 2 days)

Percentage of subjects with clinical cure at Late Follow-up

Time frame: End of Treatment Visit (Day 26 ± 2 days)

Plasma Concentration of FEP-ZID

Time frame: On Days 1 and 3 of dosing prior to infusion, within 15 minutes after the end of infusion, and at 3 timepoints up to 7 hours hours post infusion