RECRUITING

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

Conditions

Acute Pyelonephritis Complicated Urinary Tract Infection

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Official Title

A Multi-Center, Open-Label, Single-Arm, Phase 2 Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of Vabomere (Meropenem-Vaborbactam) In The Treatment Of Children With Complicated Urinary Tract Infection, Including Acute Pyelonephritis

Quick Facts

Study Start:2025-03

Study Completion:2027-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06672978

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:3 Months to 12 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Medical Information Study Director Melinta Therapeutics, LLC

CONTACT

1-844-633-6568

medinfo@melinta.com

Principal Investigator

Medical Information

STUDY_DIRECTOR

Melinta Therapeutics, LLC

Study Locations (Sites)

Children's Hospital of Orange County

Orange, California, 92868

United States

Collaborators and Investigators

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

Medical Information, STUDY_DIRECTOR, Melinta Therapeutics, LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03

Study Completion Date2027-07

Study Record Updates

Study Start Date2025-03

Study Completion Date2027-07

Terms related to this study

Additional Relevant MeSH Terms

Acute Pyelonephritis
Complicated Urinary Tract Infection