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NCT Number: NCT06828848

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

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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Key information

Conditions

Gram Negative Infections

Age range

0 month–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Fakultni nemocnice Ostrava, Ostrava, Czechia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Meropenem plus vaborbactam

Drug

Meropenem plus vaborbactam fixed dose combination adjusted by body weight up to 2g/2g

Primary outcomes

  1. Area under the concentration-time curve (AUC) for Meropenem

    Time frame: Day 3

  2. Area under the concentration-time curve (AUC) for Vaborbactam

    Time frame: Day 3

  3. Maximum plasma concentration (Cmax) for Meropenem

    Time frame: Day 3

  4. Maximum plasma concentration (Cmax) for Vaborbactam

    Time frame: Day 3

  5. Clearance (CL) of Meropenem

    Time frame: Day 3

  6. Clearance (CL) of Vaborbactam

    Time frame: Day 3

  7. Half-life (t1/2) of Meropenem

    Time frame: Day 3

  8. Half-life (t1/2) of Vaborbactam

    Time frame: Day 3

  9. Steady-state volume of distribution (Vss) of Meropenem

    Time frame: Day 3

  10. Steady-state volume of distribution (Vss) of Vaborbactam

    Time frame: Day 3

Secondary outcomes

  1. Number of patients experiencing Treatment Emergent Adverse Events (TEAE)

    Time frame: From baseline (day 1) to the last follow up visit (up to day 30)

Study contacts

Contact information is provided by the study sponsor or research team.

Monica Bertolotti, Medical Doctor

CONTACT

[email protected]

+39 055 56809922

Sponsors and collaborators

Lead sponsor

Menarini Group

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 14, 2025
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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