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

NCT06828848 — Phase 2, Recruiting, 44 participants, Menarini Group

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An Open-label, Multicentre, Single-Arm Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of VaboremⓇ (Meropenem-Vaborbactam) in Paediatric Population With Suspected or Confirmed Gram Negative Infections, Including But Not Restricted to Complicated Urinary Tract Infections

RegistryNCT06828848
StatusRecruiting
PhasePhase 2
Study typeInterventional; na, single group, masking: none, treatment
Enrollment44 (Estimated)
SponsorMenarini Group (Industry)
ConditionsGram Negative Infections
InterventionsMeropenem plus vaborbactam (Drug)
Datesstart 2025-02-18, primary completion 2027-10-01 (estimated), completion 2027-10-01 (estimated), first posted 2025-02-14, last updated 2026-10-07
Locations22 sites in Czechia, France, Italy, Poland, Spain

Related Papers Related Patents Related Grants Related Experts
All trials for Gram Negative Infections All trials of Meropenem plus vaborbactam

-Summary

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.

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+Arms and interventions

ArmTypeInterventionsDescription
Investigational product armExperimentalDrug: Meropenem plus vaborbactamSingle arm study. All participants enrolled will receive the investigational product.
  • Meropenem plus vaborbactam (Drug): Meropenem plus vaborbactam fixed dose combination adjusted by body weight up to 2g/2g

+Outcome measures

Primary outcomes

  • Area under the concentration-time curve (AUC) for Meropenem [Day 3]
  • Area under the concentration-time curve (AUC) for Vaborbactam [Day 3]
  • Maximum plasma concentration (Cmax) for Meropenem [Day 3]
  • Maximum plasma concentration (Cmax) for Vaborbactam [Day 3]
  • Clearance (CL) of Meropenem [Day 3]
  • Clearance (CL) of Vaborbactam [Day 3]
  • Half-life (t1/2) of Meropenem [Day 3]
  • Half-life (t1/2) of Vaborbactam [Day 3]
  • Steady-state volume of distribution (Vss) of Meropenem [Day 3]
  • Steady-state volume of distribution (Vss) of Vaborbactam [Day 3]

Secondary outcomes

  • Number of patients experiencing Treatment Emergent Adverse Events (TEAE) [From baseline (day 1) to the last follow up visit (up to day 30)]

+Eligibility

Sex: All, ages: 0 Months to 17 Years

Main Inclusion Criteria:

* Written informed consent before initiation of any study-related procedures.
* Male or female, from birth to < 18 years of age, inclusive.
* Require hospitalization and a minimum of 3 days of IV antibiotic treatment for suspected or confirmed Gram negative infection as per Investigator's judgement.
* Gram negative infection, according to diagnostic criteria for complicated urinary tract infection/acute pyelonephritis (cUTI/AP), complicated intra-Abdominal Infections (cIAI), Hospital-Acquired Pneumonia/Ventilator Associated Pneumonia (HAP/VAP), Blood-Stream Infection (BSI).

Main Exclusion Criteria:

* History of any moderate or significant hypersensitivity or allergic reaction to beta-lactam antibiotics or to any component of the investigational medical product.
* Gram negative infection that in the opinion of the Investigator is unlikely to respond to the study treatment.
* In treatment with immunosuppressive agents, valproic acid, or probenecid.

+Locations (22)

FacilityCityCountryStatus
Fakultni nemocnice OstravaOstravaCzechiaTerminated
Faculty Hospital Kralovske Vinohrady, Paediatric ClinicPragueCzechiaTerminated
Hôpital mère-enfant - CHU de NantesNantesFranceRecruiting
Nice University Hospital (CHU de Nice)NiceFranceRecruiting
Hospital Armand Trousseau Clinical Research SiteParisFranceTerminated
Hôpital Robert DebréParisFranceRecruiting
CHRU de Tours Hôpital Clocheville Clinical Research SiteToursFranceTerminated
Policlinico di BariBariItalyRecruiting
Ospedale Sant'OrsolaBolognaItalyRecruiting
Giannina Gaslini InstituteGenoaItalyTerminated
Azienda Ospedaliero-Universitaria di ParmaParmaItalyRecruiting
Ospedale Pediatrico Bambino GesùRomeItalyRecruiting
Ospedale Regina MargheritaTorinoItalyRecruiting
Insytut Centrum Zdrowia Matki Polki / Polish Mother´s Memorial Hospital Research Institute (ICZMP)LodzPolandTerminated
Uniwersyteckie Centrum Kliniczne WUMWarsawPolandRecruiting
Wojskowy Instytut Medyczny - Państwowy Instytut BadawczyWarsawPolandRecruiting
Hospital Sant Joan de DeuBarcelonaSpainRecruiting
Hospital Universitario Puerta del MarCadizSpainRecruiting
Hospital Dr Josep TruetaGironaSpainRecruiting
Hospital General Universitario Gregorio MarañónMadridSpainRecruiting
Hospital Regional Universitario de MálagaMálagaSpainTerminated
Hospital Clinico Universitario de Santiago de CompostelaSantiago de CompostelaSpainTerminated