NCT06672978

Brief Summary

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).

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for phase_2

Timeline
14mo left

Started Jun 2025

Geographic Reach
6 countries

26 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress45%
Jun 2025Jul 2027

First Submitted

Initial submission to the registry

November 1, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 4, 2024

Completed
7 months until next milestone

Study Start

First participant enrolled

June 3, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

1.6 years

First QC Date

November 1, 2024

Last Update Submit

April 28, 2026

Conditions

Acute PyelonephritisComplicated Urinary Tract Infection

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Adverse Events (AEs)

    Up to 28 days

Secondary Outcomes (6)

  • 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

  • Area Under the Plasma Concentration Curve from Zero to Infinity (AUC0-inf)

    Day 1 and Day 3: Up to 3 hours post-dose

  • Overall Response (OR)

    Up to 14 days

  • Clinical Cure

    Up to 14 days

  • +1 more secondary outcomes

Study Arms (3)

Cohort 1: Age 6 to < 12 years

EXPERIMENTAL

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-VaborbactamDrug: Antibiotics

Cohort 2: Age 2 to < 6 years

EXPERIMENTAL

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-VaborbactamDrug: Antibiotics

Cohort 3: Age 3 months to < 2 years

EXPERIMENTAL

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-VaborbactamDrug: Antibiotics

Interventions

Meropenem-VaborbactamDRUG

Administered as specified in the treatment arm

Also known as: Vabomere
Cohort 1: Age 6 to < 12 yearsCohort 2: Age 2 to < 6 yearsCohort 3: Age 3 months to < 2 years
AntibioticsDRUG

Administered as prescribed by the study physician in accordance with local guidelines and regulations.

Cohort 1: Age 6 to < 12 yearsCohort 2: Age 2 to < 6 yearsCohort 3: Age 3 months to < 2 years

Eligibility Criteria

Age3 Months - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

Arkansas Children's Hospital

Little Rock, Arkansas, 72202-3591, United States

RECRUITING

Children's Hospital of Orange County

Orange, California, 92868, United States

RECRUITING

University of Nebraska Medical Center, Department of Pediatrics

Omaha, Nebraska, 68198, United States

RECRUITING

University Hospitals Rainbow Babies & Children's Hospital

Cleveland, Ohio, 44106, United States

RECRUITING

Multiprofile Hospital for Active Treatment "Sv. Ivan Rilski - 2003" OOD, Department of Pediatric Diseases

Dupnitsa, 2600, Bulgaria

RECRUITING

Multiprofile Hospital for Active Treatment "Dr. Tota Venkova", Gabrovo, Department of Pediatrics Diseases

Gabrovo, 5300, Bulgaria

RECRUITING

Multiprofile Hospital for Active Treatment - Pazardzhik, Second Department of Pediatric Diseases

Pazardzhik, Bulgaria

RECRUITING

University Multipurpose Hospital for Active Treatment "Sveti Georgi", Pediatrics Clinic

Plovdiv, Bulgaria

RECRUITING

University Multiprofile Hospital for Active Treatment 'Kanev', Ruse, Department of Pediatrics

Rousse, Bulgaria

RECRUITING

Multiprofile Hospital for Active Treatment "Dr. Ivan Seliminski", Sliven

Sliven, Bulgaria

RECRUITING

Multiprofile Hospital For Active Treatment, "Vita", Department of Urology

Sofia, Bulgaria

RECRUITING

University Hospital for Active Treatment and Emergency Medicine (UHATEM) "N. I. Pirogov" LTD, Urology Clinic, Department of Urology

Sofia, Bulgaria

RECRUITING

University Hospital for Infectious Diseases "Dr. Fran Mihaljevic"

Zagreb, 10000, Croatia

RECRUITING

JSC Vian

Batumi, Georgia

RECRUITING

Geo Hospitals LLC

Tbilisi, 0144, Georgia

RECRUITING

JSC Georgian Clinics

Tbilisi, 0159, Georgia

RECRUITING

LTD L. Managadze National Center of Urology

Tbilisi, Georgia

RECRUITING

New Hospitals LLC

Tbilisi, Georgia

RECRUITING

Vian JSC

Tbilisi, Georgia

RECRUITING

University Hospital Alexandroupolis, Department of Pediatrics

Alexandroupoli, Greece

RECRUITING

Agia Sofia Children's Hospital, Infectious Diseases, Pediatrics - General

Athens, 11527, Greece

RECRUITING

University General Hospital "Attikon", 1 Rimini Str., Chaidari, PC 12462

Athens, Greece

RECRUITING

General Hospital of Thessaloniki "Ippokratio"

Thessaloniki, 54642, Greece

RECRUITING

Papageorgiou General Hospital

Thessaloniki, Greece

RECRUITING

St. Jadwiga the Queen Provincial Hospital #2 in Rzeszow, 1st Teaching Department of Pediatrics and Pediatric Gastroenterology, Pediatric Cardiology Subdivision

Rzeszów, 35-301, Poland

RECRUITING

St. Hedwig of Silesia Hospital in Trzebnica, Pediatric Department with Infantible Sub-department

Trzebnica, 55-100, Poland

RECRUITING

MeSH Terms

Interventions

meropenem and vaborbactamAnti-Bacterial Agents

Intervention Hierarchy (Ancestors)

Anti-Infective AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Medical Information

    Melinta Therapeutics, LLC

    STUDY DIRECTOR

Central Study Contacts

Medical Information Study Director Melinta Therapeutics, LLC

CONTACT

1-844-633-6568medinfo@melinta.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2024

First Posted

November 4, 2024

Study Start

June 3, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

April 30, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

PL(2)US(4)CR(1)GE(6)GR(5)BU(8)