Imipenem/Cilastatin/XNW4107 for Hospital Acquired Bacterial Pneumonia or Ventilator-Associated Bacterial Pneumonia

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Hospital Acquired Bacterial Pneumonia or Ventilator-Associated Bacterial PneumoniaCombination of Imipenem/Cilastatin and XNW4107 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This is A Multicenter, Randomized, Double-Blind, Comparative, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous Imipenem/Cilastatin/XNW4107 in Comparison with Imipenem/Cilastatin/Relebactam in Adults with Hospital-Acquired Bacterial Pneumonia or Ventilator-Associated Bacterial Pneumonia.

Eligible Conditions
  • Hospital Acquired Bacterial Pneumonia or Ventilator-Associated Bacterial Pneumonia

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

0 Primary · 5 Secondary · Reporting Duration: Day 4; EOT: from treatment day 7 up to day 15; TOC: Day 21[±2 days]; LFU: Day 28[±3 days]

Day 28
clinical success
Day 28
By-Pathogen microbiological success
microbiological success
Day 28
all-cause mortality rate
Up to Day 28
Number of days in intensive care unit (ICU)
Number of days on a ventilator and ventilator free days
Total number of days in hospital
Day 28
Adverse events

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Imipenem/Cilastatin/Relebactam
1 of 2
Imipenem/Cilastatin/XNW4107
1 of 2

Active Control

Experimental Treatment

450 Total Participants · 2 Treatment Groups

Primary Treatment: Imipenem/Cilastatin/XNW4107 · No Placebo Group · Phase 3

Imipenem/Cilastatin/XNW4107
Drug
Experimental Group · 1 Intervention: Combination of Imipenem/Cilastatin and XNW4107 · Intervention Types: Drug
Imipenem/Cilastatin/Relebactam
Drug
ActiveComparator Group · 1 Intervention: Imipenem/Cilastatin/Relebactam · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: day 4; eot: from treatment day 7 up to day 15; toc: day 21[±2 days]; lfu: day 28[±3 days]

Who is running the clinical trial?

Sinovent Pty Ltd.Lead Sponsor
7 Previous Clinical Trials
1,033 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are willing and able to provide written informed consent or where consent is provided by legally authorized representatives.
You are willing and able to comply with all study assessments and adhere to the protocol schedule.
You have a new onset of or increase in suctioned respiratory secretions, demonstrating evidence of inflammation and absence of contamination.
You have a need for acute changes in the ventilator support system to enhance oxygenation, as determined by worsening oxygenation or needed changes in the amount of positive end-expiratory pressure.
You have HABP or VABP as defined below and requires treatment with IV antibiotic therapy.