Meropenem-Vaborbactam for Urinary Tract Infections

Recruiting at 24 trial locations

Overseen By Medical Information Study Director Melinta Therapeutics, LLC

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: Melinta Therapeutics, Inc.

Must not be taking: Beta-lactams

Disqualifiers: Dialysis, Hepatic disease, others

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

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

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 14 days

66 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and tolerability of an antibiotic called meropenem-vaborbactam, administered through an IV drip, for children with difficult urinary tract infections (UTIs), including kidney infections. The goal is to determine if this treatment can aid children who require at least a three-day hospital stay for recovery. Children with a suspected or confirmed complicated UTI who need IV antibiotics might be suitable candidates for this study. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, providing an opportunity to contribute to significant medical advancements.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on antibiotics for a urinary tract infection, you may need to stop if you've been on them for more than 24 hours in the past 72 hours, unless there's evidence of treatment failure or resistance.

Is there any evidence suggesting that meropenem-vaborbactam is likely to be safe for children with complicated urinary tract infections?

Research has shown that meropenem-vaborbactam is generally safe for treating complicated urinary tract infections (cUTI) in adults. The FDA approved it for this use in 2017. Studies found the treatment successful, with most patients tolerating it well. Common side effects included headache, diarrhea, and nausea, but these were usually mild. This trial is in an earlier phase and aims to test the drug's safety in children aged 3 months to less than 12 years. Although this age group is new for the drug, its use in adults suggests it could be safe for young participants. ^{1 2 3 4 5}

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

Meropenem-vaborbactam is unique because it combines meropenem, a powerful antibiotic, with vaborbactam, a beta-lactamase inhibitor. This combination is designed to tackle resistant bacteria by preventing them from breaking down the antibiotic before it can work. Unlike some other treatments for urinary tract infections (UTIs) that may not be effective against resistant strains, meropenem-vaborbactam targets these tough-to-treat bacteria directly. Researchers are excited about this treatment because it has the potential to treat UTIs more effectively and swiftly, particularly in patients who have infections caused by resistant bacteria.

What evidence suggests that meropenem-vaborbactam might be an effective treatment for complicated urinary tract infections?

Studies have shown that meropenem-vaborbactam effectively treats complicated urinary tract infections (cUTIs), achieving a high success rate of 98.4% compared to piperacillin-tazobactam. A detailed review found that meropenem, a component of this treatment, had the best cure rate for cUTIs at 91.4%. These findings suggest that meropenem-vaborbactam is a strong choice for managing difficult urinary tract infections. Participants in this trial will receive meropenem-vaborbactam via intravenous infusion, with the option to switch to an oral antibiotic after Day 3 if clinical improvement occurs. ^{3 5 6 7 8}

Who Is on the Research Team?

Medical Information

Principal Investigator

Melinta Therapeutics, LLC

Are You a Good Fit for This Trial?

This trial is for children aged 3 months to less than 12 years with complicated urinary tract infections or acute pyelonephritis, requiring hospitalization and IV antibiotics. They must have a positive urine test for infection and need at least a week of antibacterial therapy.

Inclusion Criteria

I need hospital treatment for a serious urinary infection.

I have a urinary tract infection that may or may not cause symptoms.

I have been diagnosed with a severe kidney infection.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive meropenem-vaborbactam via intravenous infusion for a minimum of 3 days, up to 14 days, with an option to switch to oral antibiotics after Day 3 if clinically improved

Up to 14 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Meropenem-Vaborbactam

Trial Overview The study tests the safety and how well kids handle Meropenem-Vaborbactam, an antibiotic given through IV. It's aimed at those with serious UTIs including kidney infections, to see if it helps them get better.

How Is the Trial Designed?

Group I: Cohort 3: Age 3 months to < 2 years Experimental Treatment 2 Interventions

Participants will receive meropenem-vaborbactam IV infusion for a minimum of 3 days, for up to 14 days. Participants with clinical improvement have the option to switch to an oral antibiotic after Day 3.

Group II: Cohort 2: Age 2 to < 6 years Experimental Treatment 2 Interventions

Participants will receive meropenem-vaborbactam IV infusion for a minimum of 3 days, for up to 14 days. Participants with clinical improvement have the option to switch to an oral antibiotic after Day 3.

Group III: Cohort 1: Age 6 to < 12 years Experimental Treatment 2 Interventions

Participants will receive meropenem-vaborbactam via an intravenous (IV) infusion for a minimum of 3 days, for up to 14 days. Participants with clinical improvement have the option to switch to an oral antibiotic after Day 3.

Who Is Running the Clinical Trial?

Melinta Therapeutics, Inc.

Lead Sponsor

Trials

36

Recruited

9,600+

Rempex (a wholly owned subsidiary of Melinta Therapeutics, LLC)

Lead Sponsor

Trials

2

Recruited

130+

Biomedical Advanced Research and Development Authority

Collaborator

Trials

108

Recruited

574,000+

Published Research Related to This Trial

Meropenem-vaborbactam is effective against complicated urinary tract infections and acute pyelonephritis caused by carbapenem-resistant Enterobacteriaceae, as shown in the Phase III trial TANGO I.

The drug is safe, well tolerated, and has better pharmacokinetic and pharmacodynamic profiles compared to other antibiotics targeting the same resistant bacteria, making it a valuable option for treating infections caused by K. pneumoniae carbapenemase-producing CRE.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meropenem-vaborbactam: a new weapon in the war against infections due to resistant Gram-negative bacteria. Patel, TS., Pogue, JM., Mills, JP., et al.[2019]

The combination of meropenem and vaborbactam (Vabomere) has shown strong effectiveness against Gram-negative bacteria, particularly KPC-producing, carbapenem-resistant Enterobacteriaceae, in a murine pyelonephritis model.

This combination therapy significantly enhanced bacterial killing compared to untreated controls, indicating its potential utility for treating complicated urinary tract infections caused by these resistant pathogens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Activity of Meropenem-Vaborbactam against Carbapenem-Resistant Enterobacteriaceae in a Murine Model of Pyelonephritis. Weiss, WJ., Pulse, ME., Nguyen, P., et al.[2019]

Meropenem-vaborbactam is an effective treatment for complicated urinary tract infections caused by carbapenem-resistant Enterobacteriaceae (CRE), particularly those producing Klebsiella pneumoniae carbapenemase (KPC), showing higher treatment success rates compared to traditional therapies.

This novel combination not only has lower toxicity but also presents a stronger defense against developing antimicrobial resistance, making it a preferred option for managing serious infections caused by KPC-producing CRE.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meropenem-vaborbactam for adults with complicated urinary tract and other invasive infections. Albin, OR., Patel, TS., Kaye, KS.[2019]

Citations

1. tandfonline.com tandfonline.com/doi/full/10.1080/1120009X.2025.2465129

Real-world effectiveness and safety of meropenem ... In addition, our review showed that the pooled survival rates at 30 and 90 d reached 75% (95% CI, 71–78%) and 69% (95% CI 61–76%), respectively. Overall, this ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02166476

Study Details | NCT02166476 | Efficacy/Safety of ... Meropenem-vaborbactam is being compared to piperacillin-tazobactam in the treatment of adults with complicated urinary tract infection (cUTI) or acute ...

3. academic.oup.com academic.oup.com/ofid/article/11/6/ofae273/7667230

Outcomes and Predictors of Mortality in Patients With KPC-Kp ... Most infections (62.3%) were managed with meropenem-vaborbactam monotherapy, or in combination with at least 1 other active drug (usually fosfomycin, ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11559027/

A systematic review of efficacy and safety of newer drugs ... Among the drugs used for treating complicated urinary tract infections, meropenem had the highest cure rate at 91.4%, followed by plazomicin at 88% and ...

5. vabomere.com vabomere.com/clinical-data.html

VABOMERE (meropenem and vaborbactam) ǀ Clinical ... VABOMERE® (meropenem and vaborbactam) demonstrated an overall success rate of 98.4% vs 94.3% with piperacillin/tazobactam.

6. mayoclinic.org mayoclinic.org/drugs-supplements/meropenem-and-vaborbactam-intravenous-route/description/drg-20406505

Meropenem and vaborbactam (intravenous route) Meropenem and vaborbactam combination injection is used to treat complicated urinary tract infections (cUTI), including pyelonephritis (kidney infection).

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2017/209776lbl.pdf

VABOMERE (meropenem and vaborbactam) for injection VABOMERE™ is indicated for the treatment of patients 18 years of age and older with complicated urinary tract infections (cUTI) including pyelonephritis caused ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7768741/

Early Experience With Meropenem-Vaborbactam for ... The agent was approved by the US Food and Drug Administration (FDA) for treatment of complicated urinary tract infections in August 2017 [2]. Meropenem- ...