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NCT06672978 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Acute Pyelonephritis and Complicated Urinary Tract Infection, sponsored by Rempex (a wholly owned subsidiary of Melinta Therapeutics, LLC).

Recruiting
Registry status
Phase 2
Development phase
66
Enrollment target
20
Study locations

NCT06672978: Recruiting Phase 2 study of Acute Pyelonephritis and Complicated Urinary Tract Infection, sponsored by Rempex (a wholly owned subsidiary of Melinta Therapeutics, LLC).

NCT06672978 is a Phase 2 study of Acute Pyelonephritis and Complicated Urinary Tract Infection that is actively recruiting participants, run by Rempex (a wholly owned subsidiary of Melinta Therapeutics, LLC). The registered enrollment target is 66 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06672978, a Phase 2 study of Acute Pyelonephritis and Complicated Urinary Tract Infection, is actively recruiting participants, sponsored by Rempex (a wholly owned subsidiary of Melinta Therapeutics, LLC).

RECRUITING
Registry status
Phase 2
Development phase
66 participants
Enrollment target
20
Study locations

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 Studied

Acute Pyelonephritis Complicated Urinary Tract Infection

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
Rempex (a wholly owned subsidiary of Melinta Therapeutics, LLC)

2 total trials

What NCT06672978 shows while recruiting

NCT06672978 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% lower).

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.

NCT06672978 names 20 study sites across 5 states, led by Other, Arkansas, California.

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.

What interventions are being tested in trial NCT06672978?

The interventions under investigation include: Antibiotics (DRUG), Meropenem-Vaborbactam (DRUG).

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.

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.

Learn More About Clinical Trials

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Where NCT06672978's enrollment target sits among peer trials

66 975th of 2000 higher than 1,014 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT06672978

Source: ClinicalTrials.gov NCT06672978, the US trial registry maintained by the National Library of Medicine. NCT06672978 (small enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.