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Málaga","Málaga",{"type":34,"coordinates":294},[295,296],-4.42034,36.72016,{"lat":296,"lon":295},[299],{"name":300,"role":24,"phone":301,"phoneExt":20,"email":302},"Francisco Antonio Nieto-Vega, Medical Doctor","+34 951292188","franciscoa.nieto.sspa@juntadeandalucia.es",{"facility":304,"status":30,"city":305,"state":20,"zip":20,"country":238,"countryCode":239,"cosmosGeoPoint":306,"geoPoint":310,"contacts":311},"Hospital Clinico Universitario de Santiago de Compostela","Santiago de Compostela",{"type":34,"coordinates":307},[308,309],-8.54569,42.88052,{"lat":309,"lon":308},[312],{"name":313,"role":24,"phone":314,"phoneExt":20,"email":315},"Federico Martinon, Medical Doctor","+34 981955373","federico.martinon.torres@sergas.es",{"type":317,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100579788","phase-2-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-100579788",false,"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","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","Main Inclusion Criteria:\n\n* Written informed consent before initiation of any study-related procedures.\n* Male or female, from birth to \\\u003C 18 years of age, inclusive.\n* Require hospitalization and a minimum of 3 days of IV antibiotic treatment for suspected or confirmed Gram negative infection as per Investigator's judgement.\n* Gram negative infection, according to diagnostic criteria for complicated urinary tract infection\u002Facute pyelonephritis (cUTI\u002FAP), complicated intra-Abdominal Infections (cIAI), Hospital-Acquired Pneumonia\u002FVentilator Associated Pneumonia (HAP\u002FVAP), Blood-Stream Infection (BSI).\n\nMain Exclusion Criteria:\n\n* History of any moderate or significant hypersensitivity or allergic reaction to beta-lactam antibiotics or to any component of the investigational medical product.\n* Gram negative infection that in the opinion of the Investigator is unlikely to respond to the study treatment.\n* In treatment with immunosuppressive agents, valproic acid, or probenecid.","ALL","0 Months","17 Years",{"count":329,"type":330},44,"ESTIMATED","INTERVENTIONAL",[333],"PHASE2","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 \\\u003C 18 years with suspected or confirmed Gram negative infections in need of hospitalisation and intravenous (IV) antibiotic administration.\n\nAll 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.\n\nParticipant's clinical conditions will be monitored during the entire duration of the hospitalization and during scheduled visit\u002Fs after the completion of the treatment.",[336],"Gram Negative Infections",[338,339,340,341,342,343],"pediatric","meropenem","vaborbactam","vaborem","gram negative infection","neonate","2026-02-03",{"date":346,"type":347},"2026-02-04","ACTUAL",{"date":349,"type":347},"2025-02-18",{"date":351,"type":330},"2026-07",{"name":5,"class":6},22]