Imipenem/Cilastatin/XNW4107 vs Meropenem for Urinary Tract Infection

Overseen By Yuanyuan Pan

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Sinovent Pty Ltd.

Must not be taking: Valproic acid, Divalproex

Disqualifiers: Seizure disorder, Immunodeficiency, Liver disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 21

Duration: 7-15 days

780 Participants Needed

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.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you require medication with valproic acid or divalproex.

What data supports the effectiveness of the drug Imipenem/Cilastatin/XNW4107 for treating urinary tract infections?

Research shows that Imipenem/Cilastatin is effective in treating complicated urinary tract infections, with clinical improvement in 99% of cases and bacteriological improvement in 81% of cases. This suggests that Imipenem/Cilastatin/XNW4107 could also be effective, as it includes similar components. ^{1 2 3 4 5}

Is Imipenem/Cilastatin/XNW4107 safe for humans?

Imipenem/cilastatin has been shown to be generally safe in humans, with some patients experiencing mild side effects like injection site inflammation. In studies comparing it to meropenem, both drugs were well tolerated, though meropenem had slightly fewer drug-related adverse reactions. ^{1 4 5 6 7}

How does the drug Imipenem/Cilastatin/XNW4107 differ from Meropenem in treating urinary tract infections?

Imipenem/Cilastatin/XNW4107 is unique because it combines imipenem with cilastatin to prevent the breakdown of imipenem in the kidneys, potentially enhancing its effectiveness, while Meropenem is known for having fewer drug-related side effects and a slightly better clinical response rate in some studies. ^{2 3 4 5 8}

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Imipenem/Cilastatin/XNW4107 or Meropenem for complicated urinary tract infections

7-15 days

Daily visits for infusion

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Visits on Day 21 and Day 28

Treatment Details

Interventions

• Imipenem/Cilastatin/XNW4107
• Meropenem

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+

Findings from Research

In a study involving 20 adult patients with severe bacterial infections, imipenem/cilastatin sodium demonstrated a high efficacy, with 90% of patients showing satisfactory clinical responses and a 90% pathogen eradication rate.

Both imipenem/cilastatin and cefotaxime were found to be safe, with no major adverse effects reported in either treatment group, indicating that imipenem/cilastatin is a viable option for treating severe infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative clinical evaluation of imipenem/cilastatin vs. cefotaxime in treatment of severe bacterial infections. Stamboulian, D., Argüello, EA., Jasovich, A., et al.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Intravenous meropenem versus imipenem/cilastatin in the treatment of serious bacterial infections in hospitalized patients. Meropenem Serious Infection Study Group. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Intramuscular meropenem in the treatment of bacterial infections of the urinary and lower respiratory tracts. Italian Intramuscular Meropenem Study Group. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Imipenem/cilastatin (1.5 g daily) versus meropenem (3.0 g daily) in patients with intra-abdominal infections: results of a prospective, randomized, multicentre trial. [2018]

4. Italy pubmed.ncbi.nlm.nih.gov

[Multicenter comparative study of meropenem vs. imipenem in the intramuscular treatment of hospital infections of the urinary tract]. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

A multicenter comparative study of meropenem and imipenem/cilastatin in the treatment of complicated urinary tract infections in hospitalized patients. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Comparative clinical evaluation of imipenem/cilastatin vs. cefotaxime in treatment of severe bacterial infections. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Meropenem versus imipenem/cilastatin in intra-abdominal infections requiring surgery. Meropenem Study Group. [2019]

8. Germany pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of meropenem compared to imipenem-cilastatin in young, healthy males. [2019]