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Efficacy and Safety of Cefepime/Nacubactam or Aztreonam/Nacubactam Compared to Imipenem/Cilastatin in Subjects With Complicated Urinary Tract Infections or Acute Uncomplicated Pyelonephritis (Integral-1)

Primary Purpose

Complicated Urinary Tract Infection, Acute Pyelonephritis

Status
Recruiting
Phase
Phase 3
Locations
Estonia
Study Type
Interventional
Intervention
co-administration of cefepime and nacubactam
co-administration of aztreonam and nacubactam
imipenem/cilastatin
Sponsored by
Meiji Seika Pharma Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Complicated Urinary Tract Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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; Weight at most 140 kg; 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: 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. 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. Has only a known Gram-positive primary uropathogen (at least 10^5 CFU/mL), isolated from study qualifying urine culture;

Sites / Locations

  • Meiji Research SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

co-administration of cefepime and nacubactam

co-administration of aztreonam and nacubactam

imipenem/cilastatin

Arm Description

co-administration of 2 g cefepime and 1 g nacubactam q8h (60 min. infusion)

co-administration of 2 g aztreonam and 1 g nacubactam q8h (60 min. infusion)

combination of 1 g imipenem/1 g cilastatin q8h (60 min. infusion)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 25, 2023
Last Updated
May 24, 2023
Sponsor
Meiji Seika Pharma Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05887908
Brief Title
Efficacy and Safety of Cefepime/Nacubactam or Aztreonam/Nacubactam Compared to Imipenem/Cilastatin in Subjects With Complicated Urinary Tract Infections or Acute Uncomplicated Pyelonephritis
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 23, 2023 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meiji Seika Pharma Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complicated Urinary Tract Infection, Acute Pyelonephritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
co-administration of cefepime and nacubactam
Arm Type
Experimental
Arm Description
co-administration of 2 g cefepime and 1 g nacubactam q8h (60 min. infusion)
Arm Title
co-administration of aztreonam and nacubactam
Arm Type
Experimental
Arm Description
co-administration of 2 g aztreonam and 1 g nacubactam q8h (60 min. infusion)
Arm Title
imipenem/cilastatin
Arm Type
Active Comparator
Arm Description
combination of 1 g imipenem/1 g cilastatin q8h (60 min. infusion)
Intervention Type
Drug
Intervention Name(s)
co-administration of cefepime and nacubactam
Intervention Description
2 g cefepime and 1 g nacubactam
Intervention Type
Drug
Intervention Name(s)
co-administration of aztreonam and nacubactam
Intervention Description
2 g aztreonama and 1 g nacubactam
Intervention Type
Drug
Intervention Name(s)
imipenem/cilastatin
Intervention Description
1 g imipenem/1 g cilastatin
Primary Outcome Measure Information:
Title
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.
Description
Composite clinical and microbiological success is defined as the composite clinical outcome of cure and the microbiological outcome of eradication.
Time Frame
7 [±2] days after EOT [Day 10 to 23]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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; Weight at most 140 kg; 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: 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. 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. Has only a known Gram-positive primary uropathogen (at least 10^5 CFU/mL), isolated from study qualifying urine culture;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Keisuke Suwada
Phone
+81-3-3273-3745
Email
clinical-trials@meiji.com
Facility Information:
Facility Name
Meiji Research Site
City
Meegomäe
State/Province
Voru
Country
Estonia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Investigator

12. IPD Sharing Statement

Learn more about this trial

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

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