Late-onset Sepsis MedDRA version: 20.0 Level: HLT Classification code 10040054 Term: Sepsis, bacteraemia, viraemia and fungaemia NEC System Organ Class: 100000005053
Conditions
Interventions
Trade Name: Zinforo
Product Name: ceftaroline fosamil powder for concentrate for solution for infusion
Product Code: not applicable
Pharmaceutical Form: Powder for concentrate for solution for infusio
Sponsors
Pfizer Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Informed consent in writing from parent(s) or other legally-acceptable representative(s) 2. Male or female, gestational age =34 weeks, and chronological age 7 to 38.5°C) (ii) Bradycardia OR tachycardia OR rhythm instability (iii) Urine output 0.5 to 1 mL/kg/h OR hypotension OR mottled skin OR impaired peripheral perfusion (iv) Petechial rash OR sclerema neonatorum (v) New onset or worsening of apnoea episodes OR tachypnoea episodes OR increased oxygen requirements OR requirement for ventilation support (vi) Feeding intolerance OR poor sucking OR abdominal distension (vii) Irritability (viii) Lethargy (ix) Hypotonia. 5. Patients must meet at least 1 of the following laboratory criteria: (i) White blood cell count =4,000 × 109/L OR =20,000 × 109/L (ii) Immature to total neutrophil ratio >0.2 (iii) Platelet count =100,000 × 109/L (iv) C-reactive protein (CRP) >15 mg/L OR procalcitonin =2 ng/mL (v) Hyperglycaemia OR Hypoglycaemia (vi) Metabolic acidosis. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Documented history of any hypersensitivity or allergic reaction to any ß-lactam antibiotic or aminoglycoside 2. At study entry, has confirmed infection with a pathogen known to be resistant to the combination of ceftaroline fosamil, ampicillin, and the optional aminoglycoside of choice OR confirmed viral, fungal, or parasitic pathogen as the sole cause of infection 3. Refractory septic shock within 24 hours before enrolment that does not resolve after 60 minutes of vasopressor therapy 4. Moderate or severe renal impairment defined as serum creatinine =2 times the upper limit of normal (× ULN) for age OR urine output <0.5 mL/kg/h (measured over at least 8 hours) OR requirement for dialysis 5. Evidence of progressively fatal underlying disease, or life expectancy of =60 days 6. Documented history of seizure 7. Requiring or currently taking antiretroviral therapy for human immunodeficiency virus (HIV) or a child from an HIV positive mother 8. Proven or suspected central nervous system (CNS) infection (eg, meningitis, brain abscess, subdural abscess), osteomyelitis, endocarditis, or necrotizing enterocolitis (NEC) 9. Any condition (eg, cystic fibrosis, urea cycle disorders), antepartum/peripartum factors, or procedures that would, in the opinion of the investigator, make the patient unsuitable for the study, place a patient at risk, or compromise the quality of data 10. Patient's parent(s) or legally-acceptable representative(s) involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site). Concurrent participation in another clinical study with an investigational product (IP), previous enrolment/participation in this study, or participation in another study of ceftaroline fosamil within 14 days before the intended start of the first dose of study therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and tolerability of ceftaroline for the treatment of Late-onset sepsis in neonates and young infants aged 7 to <60 days;Secondary Objective: - To evaluate the PK profile of ceftaroline in neonates and young infants aged 7 to <60 days with Late-onset sepsis - To evaluate the efficacy of ceftaroline for the treatment of Late-onset sepsis in neonates and young infants aged 7 to <60 days;Primary end point(s): The safety analysis will be performed on the Safety Analysis Set (all subjects who received drug) and will include AEs, SAEs, deaths, clinical laboratory parameters and vital signs. ;Timepoint(s) of evaluation of this end point: Duration of study including safety follow up visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Concentrations of ceftaroline fosamil, ceftaroline, and ceftaroline M-1 in plasma (and if available, concentrations of ceftaroline and ceftaroline M-1 in cerebrospinal fluid [CSF]) 2. Efficacy outcome measures will include clinical outcome at EOT and TOC in the Modified Intent-to- Treat (MITT) Analysis Set.;Timepoint(s) of evaluation of this end point: 1. Treatment period at time of sampling 2. End of Therapy vist and Test of Cure visit | — |
Countries
Hungary, Italy, Lithuania, Spain, United States
Contacts
Public ContactClinical Trials.gov Call Center
Pfizer Inc.
Outcome results
None listed