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RECRUITING Phase 2

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

NCT06672978 · View on ClinicalTrials.gov ↗

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).

Interventions

  • DRUG Antibiotics
  • DRUG Meropenem-Vaborbactam

Study Locations (20)

Other

  • Multiprofile Hospital for Active Treatment "Sv. Ivan Rilski - 2003" OOD, Department of Pediatric Diseases — Dupnitsa
  • Multiprofile Hospital for Active Treatment "Dr. Tota Venkova", Gabrovo, Department of Pediatrics Diseases — Gabrovo
  • Multiprofile Hospital for Active Treatment - Pazardzhik, Second Department of Pediatric Diseases — Pazardzhik
  • University Multipurpose Hospital for Active Treatment "Sveti Georgi", Pediatrics Clinic — Plovdiv
  • University Multiprofile Hospital for Active Treatment 'Kanev', Ruse, Department of Pediatrics — Rousse
  • Multiprofile Hospital for Active Treatment "Dr. Ivan Seliminski", Sliven — Sliven
  • Multiprofile Hospital For Active Treatment, "Vita", Department of Urology — Sofia
  • University Hospital for Active Treatment and Emergency Medicine (UHATEM) "N. I. Pirogov" LTD, Urology Clinic, Department of Urology — Sofia
  • University Hospital for Infectious Diseases "Dr. Fran Mihaljevic" — Zagreb
  • JSC Vian — Batumi
  • Geo Hospitals LLC — Tbilisi
  • JSC Georgian Clinics — Tbilisi
  • LTD L. Managadze National Center of Urology — Tbilisi
  • New Hospitals LLC — Tbilisi
  • Vian JSC — Tbilisi
  • University Hospital Alexandroupolis, Department of Pediatrics — Alexandroupoli

Arkansas

  • Arkansas Children's Hospital — Little Rock

California

  • Children's Hospital of Orange County — Orange

Nebraska

  • University of Nebraska Medical Center, Department of Pediatrics — Omaha

Ohio

  • University Hospitals Rainbow Babies & Children's Hospital — Cleveland

Trial Details

FieldValue
Enrollment Target 66 participants
Start Date 2025-06-03
Est. Completion 2027-07
Phase Phase 2

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06672978

The ClinicalTrials.gov registry entry for NCT06672978 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 66 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rempex (a wholly owned subsidiary of Melinta Therapeutics, LLC), which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Acute Pyelonephritis appearing as the primary indexed condition, and to 2 interventions — of which Antibiotics is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06672978 reports 20 study locations spanning 5 distinct geographic areas — top geographies include Other, Arkansas, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06672978 about?

NCT06672978 is a clinical study titled "A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Meropenem-Vaborbactam in 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).

What is the current status of trial NCT06672978?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 66 participants. The study started on 2025-06-03. Estimated completion is 2027-07.

What conditions does trial NCT06672978 study?

This clinical trial studies the following conditions: Acute Pyelonephritis, Complicated Urinary Tract Infection. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06672978?

The interventions under investigation include: Antibiotics (DRUG), Meropenem-Vaborbactam (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06672978?

This trial is sponsored by Rempex (a wholly owned subsidiary of Melinta Therapeutics, LLC), which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06672978 being conducted?

This trial has 20 study locations across Arkansas, California, Nebraska, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial