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

Last updated on March 14, 2019

FOR MORE INFORMATION
Study Location
Rady Children's Hospital San Diego
San Diego, California, 92123 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Late-onset Sepsis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0-59
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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 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 ( 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
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Documented history of any hypersensitivity or allergic reaction to any ?-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 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.

NCT02424734
Pfizer
Terminated
Safety, Tolerability and Efficacy of Ceftaroline in Paediatrics With Late-Onset Sepsis

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