Assessing Vaborem in Children with Complicated Urinary Tract Infections

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates how the drug Vaborem, a combination of meropenem and vaborbactam, is absorbed and tolerated in pediatric patients aged 3 months to under 18 years who are hospitalized with complicated urinary tract infections (cUTI) including acute pyelonephritis. Participants will receive Vaborem intravenously every 8 hours for 10 to 14 days, with the option to switch to oral antibiotics after a minimum of 3 days. The study will monitor the participants' clinical conditions throughout their hospitalization and during follow-up visits after treatment.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hôpital mère-enfant - CHU de Nantes
  Nantes, France Recruiting
• Nice University Hospital (CHU de Nice)
  Nice, France Recruiting
• Hôpital Robert Debré
  Paris, France Recruiting
• Policlinico di Bari
  Bari, Italy Recruiting
• Ospedale Sant'Orsola
  Bologna, Italy Recruiting
• Azienda Ospedaliero-Universitaria di Parma
  Parma, Italy Recruiting

Study contacts

• Study coordinator: Monica Bertolotti, Medical Doctor
• Email: vabor-kids@menarini-ricerche.it
• Phone: +39 055 56809922

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.