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

Study identifier:D3720C00009

ClinicalTrials.gov identifier:NCT02424734

EudraCT identifier:N/A

CTIS identifier:N/A

Recruiting

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

Phase 2

Healthy volunteers

Study drug

Ceftaroline Fosamil

Sex

All

Estimated Enrollment

Study type

Interventional

Age

7 Days - 59 Days

Date

Study Start Date: 04 Aug 2015

Estimated Primary Completion Date: 09 Oct 2017

Estimated Study Completion Date: 09 Oct 2017

Study design

Allocation: N/A
Endpoint Classification: Safety/Efficacy
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Sept 2017 by AstraZeneca

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.

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No locations available

Arms	Assigned Interventions
Experimental: Ceftaroline Fosamil Ceftaroline Fosamil	Drug: Ceftaroline Fosamil Ceftaroline Fosamil

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Investigators

Principal Investigator

David Melnick

Medical Science Director