A Study of Ceftobiprole Compared With Standard Antibiotic Treatment in Children With Staphylococcus Aureus Bacteremia (SAB) Infection, Including Right-sided Heart Infection
Staphylococcus Aureus Bacteremia · Endocarditis, Bacterial
De qué trata este estudio
El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.
- Tipo de estudio
- De intervención
- Fase
- Fase 3
- Rango de edad
- 3 días - 17 años
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 60 Estimado
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
This clinical trial will evaluate the safety, and effectiveness of ceftobiprole compared to standard-of-care antibiotic treatment in children from birth to less than 18 years of age with Staphylococcus aureus bloodstream infection, including right-sided infective endocarditis (IE). The trial will also evaluate the pharmacokinetics of ceftobiprole.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
Key Inclusion Criteria:
- Pediatric age from birth to \< 18 years old, with body weight ≥ 3.7 kg at the time of consent. Participants in the birth to \< 2-year-old cohort should have a gestational age ≥ 37 weeks and postnatal age ≥ 3 days
- Parent(s) or legal guardian(s) have provided documented informed consent, and participant has provided assent as per local standards.
- SAB:
1. Based on at least one blood culture obtained within 48 hours prior to randomization that is positive for S. aureus
2. Persistent SAB
Key Exclusion Criteria:
- Receipt of systemic antibacterial treatment for S. aureus infections exceeding 48 hours within the 7 days prior to randomization.
- Infection with S. aureus known or suspected to be non-susceptible to ceftobiprole or available SOC comparator antibiotic options
- Known concomitant bloodstream or non-bloodstream infections with Gram-negative bacteria at screening
- Left-sided IE (known or suspected to be present at the time of randomization)
- Contraindication to the administration of study treatments, including known clinically-relevant hypersensitivity to beta-lactam antibacterials
- High probability of death within 7 days due to the underlying SAB or SAB-associated disease, or high probability of death within 28 days from an unrelated underlying disease
- An absolute neutrophil count of \< 0.5 x 10\^9/L
- Septic shock or hypotension unresponsive to IV fluids with or without vasopressors for ≥ 4 hours
- SAB in participants with other foreign body material that cannot be removed within 7 days after randomization
- Suspected or confirmed metastatic central nervous system S. aureus infection
- Immunocompromising conditions
- Receipt of systemic steroids (prednisolone ≥ 2 mg/kg per day, or equivalent) or immunosuppressive drugs within 2 weeks prior to screening
- Any severe, acute or chronic medical or psychiatric condition, recent neurological event, or laboratory abnormality that may increase the risk associated with study participation or administration of study treatments, or may interfere with the interpretation of study results, and which, in the judgment of the Investigator, would make the participant inappropriate for entry into this study
- eGFR of \< 30 mL/min/1.73 m² for participants \< 2 years old and \< 15 mL/min/1.73 m² for participants ≥ 2 years old, or, for any age, requirement/anticipated requirement for plasmapheresis, peritoneal dialysis, hemodialysis, venovenous dialysis, continuous renal-replacement therapy (CRRT), or other forms of renal filtration.
- History of seizures other than well-documented febrile seizures of childhood
- Alanine transaminase (ALT) or aspartate transaminase (AST) levels \> 5 × the upper limit of normal (ULN), OR total bilirubin \> 2 × the ULN (except isolated unconjugated hyperbilirubinemia consistent with Gilbert's syndrome), OR severe hepatic disease classified as Child-Pugh class C
Tratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- Asignación al azar
- Enmascaramiento
- Enmascaramiento simple
Ceftobiprole
Participants randomized to this arm will receive intravenous (IV) ceftobiprole.
Drug: Ceftobiprole medocaril sodium
Standard-of-Care (SOC)
Participants randomized to this arm will receive intravenous (IV) standard-of-care (SOC) antibiotic treatment selected according to local guidelines or site-specific standard practice.
Drug: Standard of Care (SOC)
Ceftobiprole medocaril sodium DRUG
Ceftobiprole dosing is based on age/body weight and renal function and given at 7.5 mg/kg, 10 mg/kg, or 15 mg/kg (equivalent to 10 mg/kg, 13.3 mg/kg, or 20 mg/kg respectively of ceftobiprole medocaril sodium) q8h, q12h or q24h up to a maximum of 500 mg (equivalent to 667 mg of ceftobiprole medocaril sodium), with all doses infused over 2 hours.
Standard of Care (SOC) DRUG
Dosage is per local product label based on the participant's age/body weight, and, if applicable, renal function.
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Percentage of Participants with Treatment-Emergent Adverse Events (TEAEs)
Plazo: Day 1 through last follow-up (LFU) [up to 11 weeks]
No informado en este registro.
Percentage of participants with serious adverse events (SAEs)
Plazo: Baseline through LFU [up to 11 weeks]
No informado en este registro.
Percentage of participants with treatment-related adverse events (AEs)
Plazo: Day 1 through LFU [up to 11 weeks]
No informado en este registro.
Percentage of participants with adverse events of special interest (AESIs)
Plazo: Baseline through LFU [up to 11 weeks]
No informado en este registro.
Percentage of participants with adverse events (AEs) leading to discontinuation of study-drug treatment
Plazo: Baseline through LFU [up to 11 weeks]
No informado en este registro.
Percentage of participants with treatment-emergent abnormal hematology laboratory test results
Plazo: Baseline through the end-of-treatment (EOT) visit [up to approximately 6 weeks]
No informado en este registro.
Percentage of participants with treatment-emergent abnormal blood chemistry laboratory test results
Plazo: Baseline through the EOT visit [up to approximately 6 weeks]
No informado en este registro.
Percentage of participants with treatment-emergent abnormal urinalysis test results
Plazo: Baseline through the EOT visit [up to approximately 6 weeks]
No informado en este registro.
Change from baseline in body temperature
Plazo: Baseline through LFU visit [up to 11 weeks]
No informado en este registro.
Change from baseline in systolic blood pressure
Plazo: Baseline through LFU visit [up to 11 weeks]
No informado en este registro.
Change from baseline in diastolic blood pressure
Plazo: Baseline through LFU visit [up to 11 weeks]
No informado en este registro.
Change from baseline in respiratory rate
Plazo: Baseline through LFU visit [up to 11 weeks]
No informado en este registro.
Change from baseline in heart rate
Plazo: Baseline through LFU visit [up to 11 weeks]
No informado en este registro.
Medidas secundarias
Percentage of All-Cause Mortality (ACM)
Plazo: Through 28 days after EOT [up to approximately 10 weeks]
Defined as death from any cause including death due to SAB
Percentage of new metastatic foci or other complications of SAB
Plazo: Day 8 through test-of-cure (TOC) [up to approximately 8 Weeks]
Complications are considered new between Day 8 and TOC
Percentage of participants with Clinical Success at the TOC Visit
Plazo: TOC visit [7-14 days after EOT]
Success is defined as either cure or improvement
Percentage of participants with Microbiological Success at the TOC Visit
Plazo: TOC visit (7-14 days after EOT)
Microbiological success is defined as eradication or presumed eradication.
Percentage of participants with Overall Success at the TOC Visit
Plazo: TOC visit (7-14 days after EOT)
Overall success is defined as the achievement of both clinical success and microbiological success
Ceftobiprole Plasma Concentration
Plazo: Day 3
No informado en este registro.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (0)
El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.
No hay centros indicados. Usa el contacto oficial del estudio.
Equipo y fechas
- Patrocinador principal
- ISTx, LLC
- Inicio del estudio
- 30 oct 2026 Estimado
- Finalización primaria
- 31 oct 2028 Estimado
- Finalización del estudio
- 31 oct 2028 Estimado
- Primera publicación
- 10 nov 2026 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
A Multicenter, Randomized, Investigator-blind, Active-controlled Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of Ceftobiprole Versus Standard-of-care Treatment in Pediatric Patients From Birth to Less Than 18 Years With Staphylococcus Aureus Bacteremia, Including Right-sided Infective Endocarditis
Consulta a Wellness Clinical Research
Tu mensaje va a WCR, incluso si otra organización realiza este estudio. WCR puede orientarte, pero podría no realizar este estudio, tener acceso a su equipo ni poder inscribirte.
Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026