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New treatment option for Gram Negative Infections
Official title 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
ClinicalTrials.gov ID: NCT06828848
What this study is testing
What is Meropenem plus vaborbactam?
Meropenem plus vaborbactam is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for gram negative infections.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 0 to 17
You may be able to join if
- Main
- 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...
- Gram negative infection, according to diagnostic criteria for complicated urinary tract infection/acute pyelonephritis (cUTI/AP), complicated...
You likely can't join if
- History of any moderate or significant hypersensitivity or allergic reaction to beta-lactam antibiotics or to any component of the investigational...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Ostrava, Czechia
- Prague, Czechia
- Nantes, France
- Nice, France
- Paris, France
- Tours, France
- Bari, Italy
- Bologna, Italy
- Genoa, Italy
- Parma, Italy
- Rome, Italy
- Torino, Italy
- Lodz, Poland
- Warsaw, Poland
- Barcelona, Spain
- Cadiz, Spain
- Girona, Spain
- Madrid, Spain
- Málaga, Spain
- Santiago de Compostela, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0 months to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ostrava, Czechia; Prague, Czechia; Nantes, France; Nice, France; Paris, France; Tours, France and 14 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.