Ceftaroline Diffusion Into Cerebrospinal Fluid of Children

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

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.

Study Overview

• Status: Unknown
• Conditions: Ventriculoperitoneal Shunt; Cerebrospinal Fluid Shunts
• Intervention / Treatment: Drug: Ceftaroline

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.

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Basim Asmar, MD; Phone Number: 313-745-5862; Email: basmar@wayne.edu

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Recruiting
      • Children's Hospital of Michigan
      • Contact: Basim Asmar, MD; Phone Number: 313-745-5862; Email: basmar@wayne.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1; Single dose IV ceftaroline will be administered	Drug: Ceftaroline; Following Ceftaroline single IV dose, 3 blood and cerbrospinal fluid samples will be collected; Other Names: Teflaro; Ceftaroline Fosamil

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Basim Asmar
• Collaborators: Forest Laboratories

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: November 6, 2015
• First Submitted That Met QC Criteria: November 6, 2015
• First Posted (Estimate): November 9, 2015

Study Record Updates

• Last Update Posted (Actual): October 4, 2018
• Last Update Submitted That Met QC Criteria: October 2, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents; Anti-Bacterial Agents; Ceftaroline fosamil
• Other Study ID Numbers: CeftarolineCSF2013