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

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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Acute Pyelonephritis; Complicated Urinary Tract Infection
• Intervention / Treatment: Drug: Meropenem-Vaborbactam; Drug: Antibiotics

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Phase 2

Contacts and Locations

Study Locations

• Bulgaria
  • Dupnitsa, Bulgaria, 2600
    • Multiprofile Hospital for Active Treatment "Sv. Ivan Rilski - 2003" OOD, Department of Pediatric Diseases
  • Gabrovo, Bulgaria, 5300
    • Multiprofile Hospital for Active Treatment "Dr. Tota Venkova", Gabrovo, Department of Pediatrics Diseases
  • Pazardzhik, Bulgaria
    • Multiprofile Hospital for Active Treatment - Pazardzhik, Second Department of Pediatric Diseases
  • Plovdiv, Bulgaria
    • University Multipurpose Hospital for Active Treatment "Sveti Georgi", Pediatrics Clinic
  • Rousse, Bulgaria
    • University Multiprofile Hospital for Active Treatment 'Kanev', Ruse, Department of Pediatrics
  • Sliven, Bulgaria
    • Multiprofile Hospital for Active Treatment "Dr. Ivan Seliminski", Sliven
  • Sofia, Bulgaria
    • Multiprofile Hospital For Active Treatment, "Vita", Department of Urology
  • Sofia, Bulgaria
    • University Hospital for Active Treatment and Emergency Medicine (UHATEM) "N. I. Pirogov" LTD, Urology Clinic, Department of Urology
• Croatia
  • Zagreb, Croatia, 10000
    • University Hospital for Infectious Diseases "Dr. Fran Mihaljevic"
• Georgia
  • Batumi, Georgia
    • JSC Vian
  • Tbilisi, Georgia, 0159
    • JSC Georgian Clinics
  • Tbilisi, Georgia, 0144
    • Geo Hospitals LLC
  • Tbilisi, Georgia
    • LTD L. Managadze National Center of Urology
  • Tbilisi, Georgia
    • New Hospitals LLC
  • Tbilisi, Georgia
    • Vian JSC
• Greece
  • Alexandroupoli, Greece
    • University Hospital Alexandroupolis, Department of Pediatrics
  • Athens, Greece, 11527
    • Agia Sofia Children's Hospital, Infectious Diseases, Pediatrics - General
  • Athens, Greece
    • University General Hospital "Attikon", 1 Rimini Str., Chaidari, PC 12462
  • Thessaloniki, Greece
    • Papageorgiou General Hospital
  • Thessaloniki, Greece, 54642
    • General Hospital of Thessaloniki "Ippokratio"
• Poland
  • Rzeszów, Poland, 35-301
    • St. Jadwiga the Queen Provincial Hospital #2 in Rzeszow, 1st Teaching Department of Pediatrics and Pediatric Gastroenterology, Pediatric Cardiology Subdivision
  • Trzebnica, Poland, 55-100
    • St. Hedwig of Silesia Hospital in Trzebnica, Pediatric Department with Infantible Sub-department
• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72202-3591
      • Arkansas Children's Hospital
  • California
    • Orange, California, United States, 92868
      • Children's Hospital of Orange County
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • University of Nebraska Medical Center, Department of Pediatrics
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Rainbow Babies & Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 > 5 WBCs 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/minute/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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1: Age 6 to < 12 years; Participants will receive meropenem-vaborbactam via an 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 or home IV therapy after Day 3.	Drug: Meropenem-Vaborbactam; Administered as specified in the treatment arm; Other Names: Vabomere; Drug: Antibiotics; Administered as prescribed by the study physician in accordance with local guidelines and regulations.
Experimental: Cohort 2: Age 2 to < 6 years; 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 or home IV therapy after Day 3.	Drug: Meropenem-Vaborbactam; Administered as specified in the treatment arm; Other Names: Vabomere; Drug: Antibiotics; Administered as prescribed by the study physician in accordance with local guidelines and regulations.
Experimental: Cohort 3: Age 3 months to < 2 years; 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 or home IV therapy after Day 3.	Drug: Meropenem-Vaborbactam; Administered as specified in the treatment arm; Other Names: Vabomere; Drug: Antibiotics; Administered as prescribed by the study physician in accordance with local guidelines and regulations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants With Adverse Events (AEs)	Up to 28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Observed Plasma Concentration (Cmax)		Day 1 and Day 3: Up to 3 hours post-dose
Time to Maximum Observed Plasma Concentration (Tmax)		Day 1 and Day 3: Up to 3 hours post-dose
Overall Response (OR)	OR as assessed by the combined per-participant clinical cure and favorable microbiological response.	Up to 14 days
Clinical Cure	Clinical cure is defined as the complete resolution or significant improvement of signs and symptoms of cUTI or AP present at baseline, no new symptoms, and participant is alive.	Up to 14 days
Favorable Microbiological Response (Microbiological Eradication)	Favorable microbial response is defined as the reduction of baseline pathogen(s) (< 10^3 colony-forming units per milliliter [CFU/mL] and at least 1-log reduction from baseline) or negative urine culture, negative repeated blood culture if blood culture was positive for pathogen(s) growth at baseline, and participant is alive.	Up to 14 days
Area Under the Plasma Concentration Curve from Zero to Infinity (AUC0-inf)		Day 1 and Day 3: Up to 3 hours post-dose

Collaborators and Investigators

• Sponsor: Rempex (a wholly owned subsidiary of Melinta Therapeutics, LLC)
• Collaborators: Biomedical Advanced Research and Development Authority
• Investigators: Study Director: Medical Information, Melinta Therapeutics, LLC

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: November 1, 2024
• First Submitted That Met QC Criteria: November 1, 2024
• First Posted (Actual): November 4, 2024

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Disease Attributes; Nephritis; Nephritis, Interstitial; Pyelitis; Infections; Communicable Diseases; Urinary Tract Infections; Pyelonephritis; Anti-Infective Agents; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Anti-Bacterial Agents; meropenem and vaborbactam
• Other Study ID Numbers: ML-VAB-201-3248-2; 2024-516360-29 (EudraCT Number); U1111-1310-7249 (Other Identifier: Universal Trial Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No