Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06828848 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

A Study to Assess How Vaborem® is Taking up in the Body and Tolerated in Paediatric Patients With Gram Negative Infections, Including But Not Restricted to Complicated Urinary Tract Infections

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 2 months later Jul 2026 → Oct 2027
See other at-risk trials from Menarini Group

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Jul 2026 to Oct 2027
    • Primary endpoints: details revised at 2 of 10 entries
    • Eligibility criteria expanded, about 7 words
    • Site details revised at 2 of 22 sites
  2. Site details revised at 8 of 22 sitesv9
  3. Study sites: 21 to 22v8
  4. Study sites: 20 to 21v7
  5. Enrollment target: 32 to 44
    • Eligibility criteria expanded, about 9 words
    • Study title expanded, about 8 words
    v6
Show 4 earlier versionsHide 4 earlier versions
  1. Study sites: 18 to 20v5
  2. Study sites: 16 to 18v4
  3. Study sites: 9 to 16v3
  4. Study sites: 2 to 9
    • Start date changed from estimate of Feb 2025 to Feb 18, 2025
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 goal of this clinical trial is to assess the pharmacokinetic (PK) and safety and tolerability of Vaborem (fixed combination of meropenem and vaborbactam) in the paediatric population aged from birth to \< 18 years with suspected or confirmed Gram negative infections in need of hospitalisation and intravenous (IV) antibiotic administration. All participants will receive Vaborem IV every 8 hours to treat the suspected or confirmed Gram negative infections for 10 up to 14 days; switch to stepdown oral antibiotic is allowed after a minimum of 3 days of Vaborem. PK sample collection will occur after at least 6 doses administration. Participant's clinical conditions will be monitored during the entire duration of the hospitalization and during scheduled visit/s after the completion of the treatment.
Trial Details
NCT Number NCT06828848
Lead Sponsor Menarini Group
Conditions
(from sponsor)		 Gram Negative Infections
Enrollment 44 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov