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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 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. The trial reports 20 study locations across 5 states.
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
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
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2025-06-03 |
| Est. Completion | 2027-07 |
| Phase | Phase 2 |
Interested in This Trial?
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, categorized as Phase 2. 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.
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 reports 20 study locations spanning 5 distinct geographic areas - top geographies include 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.
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