A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Meropenem-Vaborbactam in Children With Complicated Urinary Tract Infection, Including Acute Pyelonephritis
A Multi-Center, Open-Label, Single-Arm, Phase 2 Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of Vabomere (Meropenem-Vaborbactam) In The Treatment Of Children With Complicated Urinary Tract Infection, Including Acute Pyelonephritis
Sponsor: Biomedical Advanced Research and Development Authority
This observational or N/A phase trial investigates Acute Pyelonephritis and Complicated Urinary Tract Infection and is currently actively recruiting participants. Biomedical Advanced Research and Development Authority leads this study, which shows 14 recorded versions since 2025 — indicating substantial longitudinal coverage. Longitudinal tracking of infectious disease trials helps identify durability of treatment effects.
Status Flow
Change History
14 versions recorded-
May 4, 2026 — Present [daily]
Recruiting
Phase: PHASE2 → None
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Jan 2026 — May 2026 [monthly]
Recruiting PHASE2
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Dec 2025 — Jan 2026 [monthly]
Recruiting PHASE2
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Nov 2025 — Dec 2025 [monthly]
Recruiting PHASE2
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Oct 2025 — Nov 2025 [monthly]
Recruiting PHASE2
▶ Show 9 earlier versions
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Sep 2025 — Oct 2025 [monthly]
Recruiting PHASE2
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Aug 2025 — Sep 2025 [monthly]
Recruiting PHASE2
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Jul 2025 — Aug 2025 [monthly]
Recruiting PHASE2
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Jun 2025 — Jul 2025 [monthly]
Recruiting PHASE2
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May 2025 — Jun 2025 [monthly]
Recruiting PHASE2
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Apr 2025 — May 2025 [monthly]
Recruiting PHASE2
Status: Not Yet Recruiting → Recruiting
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Mar 2025 — Apr 2025 [monthly]
Not Yet Recruiting PHASE2
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Jan 2025 — Mar 2025 [monthly]
Not Yet Recruiting PHASE2
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Dec 2024 — Jan 2025 [monthly]
Not Yet Recruiting PHASE2
First recorded
Eligibility 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).
Contact Information
- Biomedical Advanced Research and Development Authority
- Rempex (a wholly owned subsidiary of Melinta Therapeutics, LLC)
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
Alexandroupoli, Greece , Athens, Greece , Athens, Greece , Batumi, Georgia , Cleveland, United States , Dupnitsa, Bulgaria , Gabrovo, Bulgaria , Little Rock, United States , Omaha, United States , Orange, United States and 16 more locations