A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Meropenem-Vaborbactam in Children With Complicated Urinary Tract Infection, Including Acute Pyelonephritis

Launched by REMPEX (A WHOLLY OWNED SUBSIDIARY OF MELINTA THERAPEUTICS, LLC) · Nov 1, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called meropenem-vaborbactam for children with complicated urinary tract infections (cUTIs), including a specific type known as acute pyelonephritis. The goal is to see if this treatment is safe and well-tolerated when given through an intravenous (IV) infusion. The study is open to children aged 3 months to under 12 years who need to be hospitalized and receive at least 3 days of IV antibiotics for their infection.

To be eligible for the trial, participants must have a confirmed or suspected cUTI or acute pyelonephritis and meet certain health criteria, such as having specific signs of infection in their urine. However, children with known allergies to certain antibiotics or those with specific health issues, like severe liver disease or kidney problems, cannot participate. If enrolled, participants will receive the treatment and be monitored for any side effects and overall health during their hospital stay. This trial aims to help find effective treatments for serious urinary infections in children.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • Have a clinically suspected and/or bacteriologically documented cUTI or AP judged by the Investigator to require hospitalization for treatment with at least 3 days of IV antibiotics.
• * Evidence of pyuria, confirmed by either of the following:
• • A urine specimen that is positive for leukocyte esterase via urine dipstick or urinalysis, or
• • A urine specimen with either \> 10 white blood cells (WBCs) per microliter from an unspun urine or \> 5WBCs per high power field from a centrifuged specimen
• • Symptomatic or asymptomatic cUTI or AP as specified in the protocol.
• • Acute Pyelonephritis (qualifying symptoms specified in protocol)
• • Have a pretreatment "baseline" urine specimen obtained for culture by an acceptable method, including suprapubic aspiration (SPA), clean urethral catheterization, in dwelling urethral catheter, or mid-stream clean catch (urine specimens obtained from externally placed urine bags will not be allowed) within 48 hours before the start of the administration of the first dose of IV study drug therapy.
• • Must, based on the judgment of the Investigator, require hospitalization initially and 7 to14 days of antibacterial therapy for the treatment of the presumed cUTI.
• Key Exclusion Criteria:
• • History of hypersensitivity or allergic reaction to beta-lactam antibiotics (for example \[e.g.\],cephalosporins, penicillins, carbapenems, monobactams).
• • Known Vabomere-resistant gram-negative organism from study-qualifying urine or blood culture, confirmed cUTI or AP only due to gram-positive organism from study-qualifying urine or blood culture, or known or suspected infection with organisms that are not adequately covered by Vabomere (e.g., viral, mycobacterial, fungal).
• • Receipt of a potentially effective antibacterial drug therapy for cUTI for a duration of more than 24 hours during the previous 72 hours prior to enrollment. Exceptions: participants with unequivocal clinical evidence of treatment failure (that is, worsening signs and symptoms); urine culture confirms resistance to the initial antibiotic; or the participant developed signs and symptoms of cUTI or AP while on antibiotics for another indication.
• • Participants undergoing dialysis or with estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m\^2, as calculated using the updated bedside Schwartz formula.
• • Evidence of significant hepatic disease or dysfunction, including known acute viral or inactive chronic hepatitis or hepatic encephalopathy, or aspartate aminotransferase or alanine aminotransferase \> 3 × upper limit normal (ULN), or total bilirubin \> 1.5 × ULN.
• • Note: Other protocol-defined Inclusion/Exclusion criteria may apply.