Ceftaroline Diffusion Into Cerebrospinal Fluid of Children

Ventriculoperitoneal Shunt Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02600793
• Other study ID #: CeftarolineCSF2013
• Status: Recruiting
• Phase: Phase 1
• Start date: August 2016
• Est. completion date: December 2019

Study information

• Verified date: October 2018
• Source: Wayne State University
• Contact: Basim Asmar, MD
• Phone: 313-745-5862
• Email: basmar[@]wayne.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebrospinal Fluid Shunts
• Ventriculoperitoneal Shunt

Intervention

Drug:
• Ceftaroline
Following Ceftaroline single IV dose, 3 blood and cerbrospinal fluid samples will be collected

Locations

Country	Name	City	State
United States	Children's Hospital of Michigan	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Basim Asmar	Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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