Safety, Tolerability and Efficacy of Ceftaroline in Paediatrics With Late-Onset Sepsis

Study identifier:D3720C00009

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Terminated/Withdrawn

Official Title

Open-label, Multicentre Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Efficacy Of Ceftaroline In Neonates And Young Infants With Late-onset Sepsis

Medical condition

Late-onset Sepsis

Phase

Healthy volunteers

Study drug

Ceftaroline Fosamil, Ampicillin, Aminoglycoside

Sex

All

Actual Enrollment

Study type

Age

7 Days - 59 Days

Date

Study Start Date: -

Primary Completion Date: -

Study Completion Date: -

Study design

Allocation: -
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -

Verification:

Collaborators

PRA Health Sciences

Inclusion and exclusion criteria

Inclusion Criteria

- Informed consent in writing from parent(s) or other legally-acceptable
representative(s); - Male or female, gestational age ≥34 weeks, and chronological age 7 to<60 days
at the time of screening; - Diagnosis of sepsis within 36 hours before enrolment, defined as the
presence of at least 2 clinical criteria and at least 1 laboratory criterion in the presence of or
as a result of suspected or proven bacterial infection that requires IV antibiotic therapy; -
Patients must meet at least 2 of the following clinical criteria :Hypothermia (<36°C) OR fever
(>38.5°C); Bradycardia OR tachycardia OR rhythm instability; Urine output 0.5 to 1 mL/kg/h OR
hypotension OR mottled skin OR impaired peripheral perfusion; Petechial rash OR sclerema neonatorum;
New onset or worsening of apnoea episodes OR tachypnoea episodes OR increased oxygen requirements OR
requirement for ventilation support; Feeding intolerance OR poor sucking OR abdominal distension;
Irritability; Lethargy; Hypotonia: - Patients must meet at least 1 of the following laboratory
criteria: White blood cell count ≤4,000 × 109/L OR ≥20,000 × 109/L; Immature to total neutrophil
ratio >0.2; Platelet count ≤100,000 × 109/L; C-reactive protein (CRP) >15 mg/L OR procalcitonin ≥2
ng/mL; Hyperglycaemia OR Hypoglycaemia; Metabolic acidosis.

Exclusion Criteria

- Documented history
of any hypersensitivity or allergic reaction to any β-lactam antibiotic or aminoglycoside; - 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; - Refractory septic shock within 24
hours before enrolment that does not resolve after 60 minutes of vasopressor therapy; - 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; -
Evidence of progressively fatal underlying disease, or life expectancy of ≤60 days; - Documented
history of seizure; - Requiring or currently taking antiretroviral therapy for human
immunodeficiency virus (HIV) or a child from an HIV positive mother; - Proven or suspected central
nervous system (CNS) infection (eg, meningitis, brain abscess, subdural abscess), osteomyelitis,
endocarditis, or necrotizing enterocolitis (NEC); - 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; - 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.

No locations available

Arms	Assigned Interventions
Ceftaroline Fosamil	-

Documents available

To obtain contact information for a study center near you, click here.
Download
Trial Results Summaries
Available here

Contacts

Investigators

Principal Investigator

null null Pfizer CT.gov Call Center

Pfizer