Ceftaroline Diffusion Into Cerebrospinal Fluid of Children

Basim Asmar

Status and phase: Unknown; Phase 1

Conditions: Cerebrospinal Fluid Shunts; Ventriculoperitoneal Shunt

Treatments: Drug: Ceftaroline

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02600793

CeftarolineCSF2013

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 12 estimated patients

Sex: All

Ages: 6 months to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Arm 1

Experimental group

Description:

Single dose IV ceftaroline will be administered

Treatment:

Drug: Ceftaroline