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

Acute Pyelonephritis Clinical Trial

— Integral-1  

Official title:

A Phase 3, Multi-Center, Randomized, Double-Blind 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 or Acute Uncomplicated Pyelonephritis, in Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05887908
• Other study ID #: OP0595-5
• Status: Recruiting
• Phase: Phase 3
• Start date: May 23, 2023
• Est. completion date: August 2024

Study information

• Verified date: April 2023
• Source: Meiji Seika Pharma Co., Ltd.
• Contact: Keisuke Suwada
• Phone: +81-3-3273-3745
• Email: clinical-trials[@]meiji.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male or female patients at least18 years of age (or age of legal consent, whichever is older) at the time of obtaining informed consent and who can be hospitalized throughout the Treatment Period;

2. Weight at most 140 kg;

3. Expectation, in the opinion of the Investigator, that the patient's cUTI or AP will require treatment with at least 5 days of IV antibiotics;

Exclusion Criteria:

1. Has a known imipenem- and/or meropenem-resistant Gram-negative uropathogen (at least 10^5 CFU/mL), isolated from study-qualifying urine culture; Note: If after randomization the susceptibility testing indicates resistance to imipenem and/or meropenem, the patient may remain on the study drug at the Investigator's discretion.

2. Has known or suspected single or concurrent infection with Acinetobacter spp. or other organisms that are not adequately covered by the study drug (eg, concurrent viral, mycobacterial, or fungal infection) and needs to be managed with other anti-infectives; Note: Patients with qualifying pathogen coinfected with a Gram-positive pathogen may be administered narrow spectrum, open-label glycopeptide (eg, vancomycin), oxazolidinone (eg, linezolid), or daptomycin concomitantly with the study drug at the Investigator's discretion.

3. Has only a known Gram-positive primary uropathogen (at least 10^5 CFU/mL), isolated from study qualifying urine culture;

Related Conditions & MeSH terms

• Acute Pyelonephritis
• Communicable Diseases
• Complicated Urinary Tract Infection
• Infections
• Pyelonephritis
• Urinary Tract Infections

Intervention

Drug:
• co-administration of cefepime and nacubactam
2 g cefepime and 1 g nacubactam
• co-administration of aztreonam and nacubactam
2 g aztreonama and 1 g nacubactam
• imipenem/cilastatin
1 g imipenem/1 g cilastatin

Locations

Country	Name	City	State
Estonia	Meiji Research Site	Meegomäe	Voru

Sponsors (1)

Lead Sponsor	Collaborator
Meiji Seika Pharma Co., Ltd.

Country where clinical trial is conducted

Estonia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary efficacy endpoint is the proportion of patients who achieve composite clinical and microbiological success at TOC in the Microbiological Modified Intent-to-Treat (m-MITT) Population.	Composite clinical and microbiological success is defined as the composite clinical outcome of cure and the microbiological outcome of eradication.	7 [±2] days after EOT [Day 10 to 23]