What side effects are associated with this type of intervention?

Common treatments for urinary tract infections (UTIs) involving broad-spectrum beta-lactam antibiotics, such as imipenem, often include side effects like allergic reactions, rash, diarrhea, and renal toxicity. High doses can lead to seizures. When combined with cilastatin, a renal dehydropeptidase inhibitor, the risk of nephrotoxicity is reduced but not eliminated. Beta-lactamase inhibitors like funobactam can cause gastrointestinal disturbances and hypersensitivity reactions. Overall, while these combinations are effective, they must be used cautiously due to potential adverse effects.

What prior FDA approvals exist?

The FDA has approved several treatments for Urinary Tract Infections (UTIs) that are similar to the combination of Intravenous Imipenem/Cilastatin/Funobactam. Notably, combinations like Imipenem/Cilastatin alone have been used for complicated UTIs due to their broad-spectrum activity. Additionally, other carbapenem-beta-lactamase inhibitor combinations, such as Meropenem/Vaborbactam and Ceftazidime/Avibactam, have been approved for treating complicated UTIs, including those caused by multidrug-resistant organisms. These combinations work by inhibiting bacterial cell wall synthesis and protecting the antibiotic from degradation by beta-lactamase enzymes, thereby extending their spectrum of activity.

What other types of research exist?

Promising novel alternatives to Intravenous Imipenem/Cilastatin/Funobactam for UTI treatment in 2024 include Ceftazidime-Avibactam and Ceftolozane-Tazobactam. Both combinations have shown efficacy against Gram-negative bacterial infections, including those caused by multidrug-resistant organisms. Ceftazidime-Avibactam is particularly effective against carbapenem-resistant Enterobacteriaceae, while Ceftolozane-Tazobactam has demonstrated activity against Pseudomonas aeruginosa and other resistant pathogens.

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Beta-lactam antibiotics

Imipenem/Cilastatin/XNW4107 vs Meropenem for Urinary Tract Infection

Phase 3

Waitlist Available

Research Sponsored by Sinovent Pty Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Evidence of AP or cUTI

Requiring treatment with IV antibiotic therapy

Must not have

If the culture result is available prior to randomization and identifies only a Gram-positive pathogen and/or only a Gram negative pathogen (>10^5 CFU/mL) known to be resistant to meropenem

Receipt of more than 24 hours of a potentially effective systemic antibacterials within 72 hours prior to start of study therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 4; eot: from treatment day 7 up to day 15; toc: day 21[±2 days]; lfu: day 28[±3 days]

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include allergic reactions to antibiotics such as rashes or itching; gastrointestinal issues like nausea or diarrhea; possible liver enzyme changes; and risk of seizures especially for those with seizure disorders.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a complicated urinary tract infection or acute pyelonephritis.

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I need treatment with antibiotics through an IV.

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I am 18 or older and in the hospital for a complicated urinary tract infection or acute pyelonephritis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My infection is caused by bacteria resistant to meropenem.

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

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I am on dialysis.

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I have urinary symptoms caused by an STD.

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I have a history of seizures.

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My urinary tract is completely and permanently blocked.

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I am a woman able to have children and will not use birth control during the study.

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I have a long-term condition where urine flows back to my kidneys.

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I have severe blood in my urine needing treatment beyond study medication.

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I need to take valproic acid or divalproex for my condition.

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My kidney function is very low, as measured by a specific test.

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I am not pregnant, breastfeeding, or have a positive pregnancy test.

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My condition is worsening quickly and threatens my life.

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I have or might have a kidney abscess.

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I have or might have an infection in my prostate, testicle, or epididymis.

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I have or might have an abscess near my kidney.

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I have polycystic kidney disease or only one working kidney.

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I have a history of serious liver disease.

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I have a weak immune system due to a condition like HIV, cancer, or I'm on long-term steroids.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 4; eot: from treatment day 7 up to day 15; toc: day 21[±2 days]; lfu: day 28[±3 days]

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 4; eot: from treatment day 7 up to day 15; toc: day 21[±2 days]; lfu: day 28[±3 days]

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 4; eot: from treatment day 7 up to day 15; toc: day 21[±2 days]; lfu: day 28[±3 days] for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

By-pathogen microbiological success

The proportion of overall success; symptomatic clinical, and microbiologic success

clinical success

+3 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Imipenem/Cilastatin/XNW4107Experimental Treatment1 Intervention

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

Group II: MeropenemActive Control1 Intervention

Meropenem 1g ,q8h (0.5h infusion)

0 / 22Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Urinary Tract Infections (UTIs) often include combinations like Intravenous Imipenem/Cilastatin/Funobactam. Imipenem is a broad-spectrum beta-lactam antibiotic that inhibits bacterial cell wall synthesis, leading to bacterial cell death. Cilastatin is a renal dehydropeptidase inhibitor that prevents the degradation of imipenem in the kidneys, enhancing its effectiveness. Funobactam is a beta-lactamase inhibitor that protects imipenem from being broken down by beta-lactamase enzymes produced by resistant bacteria. This combination is essential for UTI patients as it provides a robust treatment against a wide range of pathogens, including resistant strains, thereby improving treatment outcomes and reducing the risk of resistance.

Efficacy and safety of ceftazidime-avibactam versus imipenem-cilastatin in the treatment of complicated urinary tract infections, including acute pyelonephritis, in hospitalized adults: results of a prospective, investigator-blinded, randomized study.