Meropenem-Vaborbactam for Urinary Tract Infections

Recruiting at 2 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

Trial Summary

What is the purpose of this trial?

The primary objective of the study is to assess the safety and tolerability of meropenem-vaborbactam administered by intravenous (IV) infusion in children 3 months and above to less than 12 years with complicated urinary tract infections (cUTI), including acute pyelonephritis (AP)

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.

What data supports the effectiveness of the drug Meropenem-Vaborbactam for urinary tract infections?

Research shows that Meropenem-Vaborbactam is effective against complicated urinary tract infections, especially those caused by drug-resistant bacteria. In clinical trials, it was found to be more successful and safer than some traditional treatments, with better outcomes in treating infections caused by resistant bacteria. ^{1 2 3 4 5}

Is Meropenem-Vaborbactam safe for humans?

Meropenem-Vaborbactam appears to be safe and well tolerated in humans, with studies showing it has a similar risk of side effects compared to other treatments. It is associated with lower rates of toxicity and is considered a preferred option for certain infections. ^{1 2 3 4 6}

What makes the drug Meropenem-Vaborbactam unique for treating urinary tract infections?

Meropenem-Vaborbactam is unique because it combines a powerful antibiotic with a beta-lactamase inhibitor, making it effective against tough, drug-resistant bacteria that cause complicated urinary tract infections. This combination is particularly effective against bacteria that produce enzymes called carbapenemases, which make them resistant to many other antibiotics. ^{1 2 3 4 7}

Research Team

Medical Information

Principal Investigator

Melinta Therapeutics, LLC

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Correction to: Meropenem/Vaborbactam: A Review in Complicated Urinary Tract Infections. [2019]

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

Meropenem-vaborbactam for adults with complicated urinary tract and other invasive infections. [2019]

3. Germany pubmed.ncbi.nlm.nih.gov

Meropenem-vaborbactam: a carbapenem and beta-lactamase inhibitor with activity against carbapenem-resistant Enterobacteriaceae. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Meropenem-vaborbactam: a new weapon in the war against infections due to resistant Gram-negative bacteria. [2019]

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

Activity of Meropenem-Vaborbactam against Carbapenem-Resistant Enterobacteriaceae in a Murine Model of Pyelonephritis. [2019]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Meropenem-Vaborbactam in the Treatment of Acute Bacterial Infections. [2020]

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

Meropenem-vaborbactam for the treatment of complicated urinary tract infections including acute pyelonephritis. [2019]