Ceftaroline Diffusion Into Cerebrospinal Fluid of Children

Study Overview
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Brief Summary
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Ceftaroline fosamil is an intravenous (IV) drug that belongs to a group of antibiotics called cephalosporins . Antibiotics are drugs used to treat infections. Clinical studies in adults patient shave shown ceftaroline fosamil to be effective against many bacteria that are resistant to other currently approved antibiotics. Some of these bacteria may be responsible for infections in the central nervous system.The main aim of this study is to gather information to determine how much of a single IV dose of ceftaroline fosamil will enter into a child's CSF so that the benefit of giving ceftaroline fosamil to children with infections can be better determined.

Detailed Description
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Children 6 months to 17 years of age admitted to the hospital because of infected VPS (ventriculitis) will be eligible for the study. A total of twelve eligible patients will be included in the study. Eligible study subjects would be patients who have undergone VPS removal and placement of EVD tubing and are being treated with standard IV antibiotics for ventriculitis. CSF cultures are obtained before antibiotics treatment is initiated. Standard initial antibiotics regimen is usually IV ceftriaxone and vancomycin. The antibiotics regimen is subsequently adjusted based on the pathogen recovered from the CSF culture. Total IV antibiotic treatment is usually 14 days. Following clearance of the infection the patient undergoes new VPS insertion by neurosurgery service.

Official Title
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Ceftaroline Diffusion Into Cerebrospinal Fluid of Children With Ventriculitis Due to Ventriculoperitoneal Shunt (VPS) Infection

Conditions
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Cerebrospinal Fluid Shunts, Ventriculoperitoneal Shunt

Intervention / Treatment
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* Drug: Ceftaroline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 6 months - 17 years Ventriculitis due to VPS infection (abnormal CSF parameters consistent with meningeal inflammation and/or positive CSF culture) VPS is externalized and External Ventriculostomy Drain (EVD) is in place Patient has IV access and is receiving antibiotic treatment for VPS infection Parent/Guardian signed written informed consent Negative urine or serum pregnancy test for females of child-bearing potential Exclusion Criteria: Known Allergy to beta-lactam antibiotics Moderate to severe renal impairment (Creatinine clearance < 50mL/minute) Parent/Guardian written consent cannot be obtained Positive urine or serum pregnancy test

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Single dose IV ceftaroline will be administered | Drug: Ceftaroline<br>* Following Ceftaroline single IV dose, 3 blood and cerbrospinal fluid samples will be collected<br>* Other names: Teflaro;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic assessment of Ceftaroline diffusion from blood into the Cerbrospinal fluid. | Serial collection of three blood and three cerbrospinal fluid sample over 8 hours | 8 hours |