Imipenem/Cilastatin/XNW4107 vs Meropenem for Urinary Tract Infection

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Sinovent Pty Ltd.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing a combination of three drugs given through an IV to treat severe urinary tract infections in hospitalized adults. The treatment aims to kill bacteria, prevent the main drug from being broken down, and stop bacteria from resisting the treatment. The goal is to see if this new combination is more effective and safer than an existing antibiotic called Meropenem, which has been used effectively to treat complicated urinary tract infections and other bacterial infections.

Research Team

Jason Le

Principal Investigator

Evopoint Biosciences Inc.

Eligibility Criteria

Adults hospitalized or needing hospitalization for complicated urinary tract infections (cUTI) or acute pyelonephritis (AP), who are willing to follow study procedures and can give informed consent. Excluded are those with certain abscesses, one functional kidney, severe non-urinary infections, recent surgery, poor renal function, known drug allergies, immunodeficiency conditions, or on disallowed treatments.

Inclusion Criteria

I have a complicated urinary tract infection or acute pyelonephritis.

I need treatment with antibiotics through an IV.

You have at least one of the specific health issues related to complicated urinary tract infections.

Exclusion Criteria

I haven't taken strong antibiotics for more than a day within the last 3 days.

I am on dialysis.

I have urinary symptoms caused by an STD.

Treatment Details

Interventions

• Imipenem/Cilastatin/XNW4107 (Beta-lactam antibiotics)
• Meropenem (Beta-lactam antibiotics)

Trial Overview The trial is testing the effectiveness and safety of a new antibiotic combination (Imipenem/Cilastatin/XNW4107) versus Meropenem in treating cUTI including AP. It's a phase 3 study where participants are randomly assigned to either treatment group in a double-blind manner.

Participant Groups

Group I: Imipenem/Cilastatin/XNW4107 Experimental Treatment 1 Intervention

Imipenem/Cilastatin 500mg/500mg in combination with XNW4107 250mg ,q6h(0.5h infusion)

Group II: Meropenem Active Control 1 Intervention

Meropenem 1g ,q8h (0.5h infusion)

Who Is Running the Clinical Trial?

Sinovent Pty Ltd.

Lead Sponsor

Trials

8

Recruited

1,500+

Evopoint Biosciences Inc.

Lead Sponsor

Trials

15

Recruited

2,800+