Assessing Vaborem in Children with Complicated Urinary Tract Infections
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
This study is testing if the drug Vaborem is safe and works well for children in the hospital who have complicated urinary tract infections.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 0 Months to 17 Years |
| Sex | All |
| Sponsor | Menarini Group Industry-sponsored |
| Locations | 22 sites (Ostrava and 21 other locations) |
| Trial ID | NCT06828848 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients aged 3 months to under 18 years who require hospitalization for complicated urinary tract infections or acute pyelonephritis.
Not a fit: Patients with a history of significant allergic reactions to beta-lactam antibiotics or those whose condition is unlikely to respond to the treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for children suffering from complicated urinary tract infections.
How similar studies have performed: Other studies have shown success with similar antibiotic approaches in treating complicated urinary tract infections, suggesting potential for positive outcomes in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Ostrava and 21 other locations
- Fakultni nemocnice Ostrava — Ostrava, Czechia (Recruiting)
- Faculty Hospital Kralovske Vinohrady, Paediatric Clinic — Prague, Czechia (Recruiting)
- Hôpital mère-enfant - CHU de Nantes — Nantes, France (Recruiting)
- Nice University Hospital (CHU de Nice) — Nice, France (Recruiting)
- Hospital Armand Trousseau Clinical Research Site — Paris, France (Recruiting)
- Hôpital Robert Debré — Paris, France (Recruiting)
- CHRU de Tours Hôpital Clocheville Clinical Research Site — Tours, France (Recruiting)
- Policlinico di Bari — Bari, Italy (Recruiting)
- Ospedale Sant'Orsola — Bologna, Italy (Recruiting)
- Giannina Gaslini Institute — Genoa, Italy (Recruiting)
- Azienda Ospedaliero-Universitaria di Parma — Parma, Italy (Recruiting)
- Ospedale Pediatrico Bambino Gesù — Rome, Italy (Recruiting)
- Ospedale Regina Margherita — Torino, Italy (Recruiting)
- Insytut Centrum Zdrowia Matki Polki / Polish Mother´s Memorial Hospital Research Institute (ICZMP) — Lodz, Poland (Withdrawn)
- Uniwersyteckie Centrum Kliniczne WUM — Warsaw, Poland (Recruiting)
- Wojskowy Instytut Medyczny - Państwowy Instytut Badawczy — Warsaw, Poland (Recruiting)
- Hospital Sant Joan de Deu — Barcelona, Spain (Recruiting)
- Hospital Universitario Puerta del Mar — Cadiz, Spain (Recruiting)
- Hospital Dr Josep Trueta — Girona, Spain (Recruiting)
- Hospital General Universitario Gregorio Marañón — Madrid, Spain (Recruiting)
- Hospital Regional Universitario de Málaga — Málaga, Spain (Recruiting)
- Hospital Clinico Universitario de Santiago de Compostela — Santiago de Compostela, Spain (Recruiting)
Study contacts
- Study coordinator: Monica Bertolotti, Medical Doctor
- Email: vabor-kids@menarini-ricerche.it
- Phone: +39 055 56809922
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.