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

NCT06672978 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2026-04-30

No results posted yet for this study

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).

Conditions

  • Acute Pyelonephritis
  • Complicated Urinary Tract Infection

Interventions

DRUG

Meropenem-Vaborbactam

Administered as specified in the treatment arm

DRUG

Antibiotics

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

Sponsors & Collaborators

Principal Investigators

  • Medical Information · Melinta Therapeutics, LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Months
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-03
Primary Completion
2027-01-31
Completion
2027-07-31
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Croatia
  • Georgia
  • Greece
  • Poland

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06672978 on ClinicalTrials.gov