A Multicenter, Randomized, Observer-Blinded, Active-Controlled Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of Ceftaroline Versus Comparator in Pediatric Subjects With Acute Bacterial Skin and Skin Structure Infections

CompletadoFase 3ClinicalTrials.gov

ID: NCT01400867Tipo: INTERVENTIONALInicio: 1 de dic de 2011Fin estimado: 1 de jul de 2014

Dermatología Enfermedades Infecciosas Pediatría

Traducción no disponible, mostrando original

Resumen

This is a study of safety, effectiveness, blood levels and tolerance of Ceftaroline fosamil in children with skin infections receiving antibiotic therapy in the hospital.

Descripción detallada

To evaluate safety, effectiveness, pharmacokinetics and tolerance of Ceftaroline fosamil in children who are initially hospitalized with Acute Bacterial Skin and Skin Structure Infections (ABSSSI).

Elegibilidad

Edad mínima: 2 MonthsEdad máxima: 17 YearsSexo: ALL

Criterios de inclusión

Male or female, 2 months to \< 18 years old.
Presence of ABSSSI warranting initial hospitalization.
Presence of ABSSSI with measurable margins of erythema, that includes deeper and/or extensive soft tissue involvement, or requires significant therapeutic surgical intervention

Criterios de exclusión

Documented history of any hypersensitivity or allergic reaction to vancomycin, aztreonam, or any β-lactam antimicrobial
Uncomplicated skin and soft tissue infections
More than 24 hours of prior antimicrobial therapy ≤ 96 hours before randomization.
Requirement for any concomitant systemic antimicrobial therapy
History of seizures, excluding well-documented febrile seizure of childhood.
Clinical signs or suspicion of meningitis

Intervenciones

drug

Ceftaroline fosamil

Subjects ≥ 6 months old: 12 mg/kg IV for subjects weighing ≤ 33 kg and 400 mg for subjects weighing \> 33 kg will be infused over 60 (± 10) minutes every 8 hours (q8h) (± 1 hour) Subjects \< 6 months old: 8mg/kg infused over 60 (± 10) minutes every 8 hours (q8h) (± 1 hour)

drug

Vancomycin +/- Aztreonam or Cefazolin +/- Aztreonam

Vancomycin 15mg/kg IV over 60 minutes (or a maximum of 10mg/min whichever is longer) +/- Aztreonam 30 mg/kg IV every 8 hours over 60 minutes (for infections involving gram negative pathogen suspected or confirmed) Cefazolin 75mg/kg IV divided every 8 hours over 60 minutes (for sites that do not empirically cover for MRSA) +/- Aztreonam 30 mg/kg IV every 8 hours over 60 minutes (for infections involving gram negative pathogen suspected or confirmed

drug

Cephalexin or Clindamycin or Linezolid

Possible oral switch on or after study day 4. Cephalexin: 25 mg/kg q6h PO or Clindamycin: 10 mg/kg q8h PO or Linezolid 600mg q12h (cohort 1) or 10 mg/kg q8h (cohorts 2,3 and 4) PO.

Ubicaciones

Investigational Site - Buenos Aires 1

Buenos Aires, Argentina

Investigational Site - Buenos Aires 2

Buenos Aires, Argentina

Investigational Site - Buenos Aires 3

Buenos Aires, Argentina

Investigational Site - Buenos Aires 4

Buenos Aires, Argentina

Investigational Site - Buenos Aires 5

Buenos Aires, Argentina

Investigational Site - Buenos Aires 6

Buenos Aires, Argentina

Investigational Site - Santa Fe 1

Santa Fe, Argentina

Investigational Site - Santa Fe 2

Santa Fe, Argentina

Patrocinadores

PrincipalForest Laboratories

ColaboradorAstraZeneca

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