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P3 Study to Assess Efficacy and Safety of Cefepime/Nacubactam and Aztreonam/Nacubactam Versus Best Available Therapy for Adults With Infection Due to Carbapenem Resistant Enterobacterales

NCT05905055 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2026-04-13

No results posted yet for this study

Summary

This study is a multi-center, randomized, single-blind, parallel-group study to assess the efficacy and safety, when nacubactam is coadministered with cefepime or aztreonam, compared with best available therapy (BAT), in the treatment of patients with cUTI, AP, HABP, VABP, and cIAI, due to Carbapenem Resistant Enterobacterales.

Conditions

  • Complicated Urinary Tract Infection
  • Acute Pyelonephritis
  • Hospital-acquired Bacterial Pneumonia
  • Ventilator-associated Bacterial Pneumonia
  • Complicated Intra-abdominal Infection

Interventions

DRUG

co-administration of cefepime and nacubactam

2 g cefepime and 1 g nacubactam every 8 hours for at least 5 days and up to 14 days via IV infusion over a period of 60 minutes

DRUG

co-administration of aztreonam and nacubactam

2 g aztreonam and 1 g nacubactam every 8 hours for at least 5 days and up to 14 days via IV infusion over a period of 60 minutes

DRUG

BAT

Dosage of BAT will be based per site's standard of care

Sponsors & Collaborators

  • Meiji Seika Pharma Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-22
Primary Completion
2025-09-01
Completion
2025-09-01
FDA Drug
Yes

Countries

  • China
  • Croatia
  • Czechia
  • France
  • Georgia
  • Greece
  • Israel
  • Japan
  • Latvia
  • Slovakia
  • Spain
  • Taiwan
  • Thailand
  • Turkey (Türkiye)

Study Locations

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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 NCT05905055 on ClinicalTrials.gov