MedTrace Logo

Efficacy and Safety of Cefepime/Nacubactam or Aztreonam/Nacubactam Compared to Imipenem/Cilastatin in Subjects With Complicated Urinary Tract Infections or Acute Uncomplicated Pyelonephritis

NCT05887908 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 614

Last updated 2025-12-24

Study results available
· View outcomes & findings →

Summary

Phase 3 study to evaluate the efficacy and safety of cefepime/nacubactam or aztreonam/nacubactam compared to imipenem/cilastatin in the treatment of complicated urinary tract infections (cUTI) or acute uncomplicated pyelonephritis (AP).

Conditions

  • Complicated Urinary Tract Infection
  • Acute Pyelonephritis
  • cUTI
  • AP

Interventions

DRUG

co-administration of cefepime and nacubactam

2 g cefepime and 1 g nacubactam

DRUG

co-administration of aztreonam and nacubactam

2 g aztreonama and 1 g nacubactam

DRUG

imipenem/cilastatin

1 g imipenem/1 g cilastatin

Sponsors & Collaborators

  • Meiji Seika Pharma Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-23
Primary Completion
2024-11-22
Completion
2024-11-26
FDA Drug
Yes

Countries

  • Bulgaria
  • China
  • Czechia
  • Estonia
  • Georgia
  • Japan
  • Latvia
  • Lithuania
  • Slovakia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05887908 on ClinicalTrials.gov