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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

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Re-verified, no change to tracked fieldsv19
  2. Trial status changed: Recruiting → Active, Not Recruiting
    • Site details revised at 26 of 26 sites
    v18
  3. Study sites: 24 to 26v17
  4. Secondary endpoints revised (6)
    • Study sites revised (24)
    • Eligibility criteria expanded, about 2 words
    v16
  5. Study sites: 23 to 24v15
Show 13 earlier versionsHide 13 earlier versions
  1. Study sites: 22 to 23v14
  2. Study sites: 18 to 22v13
  3. Study sites: 15 to 18v12
  4. Study sites: 11 to 15v11
  5. Study sites: 6 to 11v10
  6. Start date changed from estimate of May 2025 to Jun 3, 2025v9
  7. Study sites: 3 to 6v8
  8. Study sites: 1 to 3
    • Start date: Apr 2025 to May 2025
    v7
  9. Start date: Mar 2025 to Apr 2025v6
  10. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Feb 2025 to Mar 2025
    • Site details revised
    v5
  11. Start date: Jan 2025 to Feb 2025v4
  12. Study sites: 0 to 1v3
  13. Lead sponsor: Melinta Therapeutics, Inc. to Rempex (a wholly owned subsidiary of Melinta Therapeutics, LLC)v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT06672978
Lead Sponsor Rempex (a wholly owned subsidiary of Melinta Therapeutics, LLC)
Collaborators: Biomedical Advanced Research and Development Authority
Conditions
(from sponsor)		 Acute Pyelonephritis, Complicated Urinary Tract Infection
Enrollment 66 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov