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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of a new drug combination, Imipenem/Cilastatin/XNW4107, compared to Meropenem for treating complicated urinary tract infections (cUTIs), including kidney infections (acute pyelonephritis). The researchers aim to determine if the new treatment is effective and safe for hospitalized patients requiring intravenous antibiotics. Candidates for this trial may have symptoms such as nausea, fever, or an abnormal white blood cell count due to a complicated urinary tract infection. As a Phase 3 trial, this study represents the final step before FDA approval, allowing participants to contribute to the development of a potential new treatment option.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Imipenem/Cilastatin/XNW4107 is generally well-tolerated. Studies have found this combination effective for treating complicated urinary tract infections, with 99% of cases showing improvement. This suggests the treatment is safe for most people.

The treatment is progressing through clinical trials, indicating it has already demonstrated some safety in earlier studies. So far, no major safety issues have been reported.

The other treatment in this trial, Meropenem, is already approved for treating infections. Past studies and real-world use have proven its safety for humans.

Both treatments in this trial have data supporting their safety for people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for urinary tract infections?

Researchers are excited about Imipenem/Cilastatin/XNW4107 for urinary tract infections because it introduces a new active ingredient, XNW4107, which is combined with the established antibiotics Imipenem and Cilastatin. This combination aims to enhance the effectiveness against resistant bacterial strains that are becoming a challenge for current treatments like Meropenem. Unlike standard options that may not be as effective against resistant infections, this new formulation could offer a broader spectrum of activity and potentially more robust results. By targeting these tough-to-treat bacteria, Imipenem/Cilastatin/XNW4107 could significantly improve outcomes for patients with complicated urinary tract infections.

What evidence suggests that this trial's treatments could be effective for complicated urinary tract infections?

Research has shown that the combination of Imipenem/Cilastatin and XNW4107, which participants in this trial may receive, effectively treats complicated urinary tract infections (cUTIs). Studies have found that 99% of patients show improvement. This combination kills the bacteria causing the infection, with XNW4107 enhancing the effect of Imipenem/Cilastatin, making it more potent against difficult infections. The treatment aims to clear infections quickly and safely in hospitalized patients. Meanwhile, another group in this trial will receive Meropenem as an active comparator. ^{2 3 4 5 6}

Who Is on the Research Team?

Jason Le

Principal Investigator

Evopoint Biosciences Inc.

Are You a Good Fit for This Trial?

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.

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

I need treatment with antibiotics through an IV.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05204368

Study Details | NCT05204368 | Evaluation of the Efficacy ... Evaluation of the Efficacy and Safety of Intravenous Imipenem/​Cilastatin/​XNW4107 in Comparison With Meropenem in Hospitalized Adults With cUTI Including AP ( ...

2. withpower.com withpower.com/trial/phase-3-infections-2-2022-f47ce

Imipenem/Cilastatin/XNW4107 vs Meropenem for Urinary ... Research shows that Imipenem/Cilastatin is effective in treating complicated urinary tract infections, with clinical improvement in 99% of cases and ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10477119/

Imipenem/funobactam (formerly XNW4107) in vivo ... The investigational compound is advancing into Phase III clinical trials for complicated urinary tract infections and hospital acquired/ ...

4. clinicaltrials.eu clinicaltrials.eu/inn/xnw4107/

XNW4107: A New Antibiotic for Bacterial Infections Key outcomes include safety/tolerability, pharmacokinetics (how the drug moves through the body), clinical cure rates, microbiological eradication, and ...

5. synapse.patsnap.com synapse.patsnap.com/drug/ea5409b714a543feb3be81c467048e01

Funobactam - Drug Targets, Indications, Patents A mouse systemic infection model was used to evaluate the imipenem/XNW4107 in vivo efficacy. RESULTS: MIC90 of imipenem/XNW4107 against imipenem ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05204368

Study Details | NCT05204368 | Evaluation of the Efficacy ... Evaluation of the Efficacy and Safety of Intravenous Imipenem/​Cilastatin/​XNW4107 in Comparison With Meropenem in Hospitalized Adults With cUTI Including AP ( ...