A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Meropenem-Vaborbactam in Children With Complicated Urinary Tract Infection, Including Acute Pyelonephritis
NCT ID: NCT06672978
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
66 participants
INTERVENTIONAL
2025-06-03
2027-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Meropenem-Vaborbactam
Administered as specified in the treatment arm
Antibiotics
Administered as prescribed by the study physician in accordance with local guidelines and regulations.
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.
Meropenem-Vaborbactam
Administered as specified in the treatment arm
Antibiotics
Administered as prescribed by the study physician in accordance with local guidelines and regulations.
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.
Meropenem-Vaborbactam
Administered as specified in the treatment arm
Antibiotics
Administered as prescribed by the study physician in accordance with local guidelines and regulations.
Interventions
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Meropenem-Vaborbactam
Administered as specified in the treatment arm
Antibiotics
Administered as prescribed by the study physician in accordance with local guidelines and regulations.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
3 Months
11 Years
ALL
No
Sponsors
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Biomedical Advanced Research and Development Authority
FED
Rempex (a wholly owned subsidiary of Melinta Therapeutics, LLC)
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Information
Role: STUDY_DIRECTOR
Melinta Therapeutics, LLC
Locations
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Arkansas Children's Hospital
Little Rock, Arkansas, United States
Children's Hospital of Orange County
Orange, California, United States
University of Nebraska Medical Center, Department of Pediatrics
Omaha, Nebraska, United States
University Hospitals Rainbow Babies & Children's Hospital
Cleveland, Ohio, United States
Multiprofile Hospital for Active Treatment "Sv. Ivan Rilski - 2003" OOD, Department of Pediatric Diseases
Dupnitsa, , Bulgaria
Multiprofile Hospital for Active Treatment "Dr. Tota Venkova", Gabrovo, Department of Pediatrics Diseases
Gabrovo, , Bulgaria
Multiprofile Hospital for Active Treatment - Pazardzhik, Second Department of Pediatric Diseases
Pazardzhik, , Bulgaria
University Multipurpose Hospital for Active Treatment "Sveti Georgi", Pediatrics Clinic
Plovdiv, , Bulgaria
University Multiprofile Hospital for Active Treatment 'Kanev', Ruse, Department of Pediatrics
Rousse, , Bulgaria
Multiprofile Hospital for Active Treatment "Dr. Ivan Seliminski", Sliven
Sliven, , 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
Sofia, , Bulgaria
University Hospital for Infectious Diseases "Dr. Fran Mihaljevic"
Zagreb, , Croatia
JSC Vian
Batumi, , Georgia
Geo Hospitals LLC
Tbilisi, , Georgia
JSC Georgian Clinics
Tbilisi, , Georgia
LTD L. Managadze National Center of Urology
Tbilisi, , Georgia
New Hospitals LLC
Tbilisi, , Georgia
Vian JSC
Tbilisi, , Georgia
University Hospital Alexandroupolis, Department of Pediatrics
Alexandroupoli, , Greece
Agia Sofia Children's Hospital, Infectious Diseases, Pediatrics - General
Athens, , Greece
General Hospital of Thessaloniki "Ippokratio"
Thessaloniki, , Greece
St. Jadwiga the Queen Provincial Hospital #2 in Rzeszow, 1st Teaching Department of Pediatrics and Pediatric Gastroenterology, Pediatric Cardiology Subdivision
Rzeszów, , Poland
St. Hedwig of Silesia Hospital in Trzebnica, Pediatric Department with Infantible Sub-department
Trzebnica, , Poland
Countries
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Central Contacts
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Medical Information Study Director Melinta Therapeutics, LLC
Role: CONTACT
Facility Contacts
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Zlatomira Manolova
Role: primary
Nino Chikvaidze
Role: primary
Zaza Tchanturaia
Role: primary
Nino Kvirkvelia
Role: primary
Other Identifiers
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2024-516360-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1310-7249
Identifier Type: OTHER
Identifier Source: secondary_id
ML-VAB-201-3248-2
Identifier Type: -
Identifier Source: org_study_id