NCT02600793

Ceftaroline Diffusion Into Cerebrospinal Fluid of Children

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Basim Asmar · Academic / Other
• Sex: All
• Age: 6 Months – 17 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Cerebrospinal Fluid Shunts
• Ventriculoperitoneal Shunt

Interventions

Type	Name	Description
DRUG	Ceftaroline	Following Ceftaroline single IV dose, 3 blood and cerbrospinal fluid samples will be collected

Timeline

• Start date: 2016-08-01
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2015-11-09
• Last updated: 2018-10-04

Locations

1 site across 1 country: United States