Ceftaroline Diffusion Into Cerebrospinal Fluid of Children

NCT ID: NCT02600793

Last Updated: 2018-10-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2019-12-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1

Single dose IV ceftaroline will be administered

Group Type: EXPERIMENTAL

Ceftaroline

Intervention Type: DRUG

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

Interventions

Ceftaroline

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

Intervention Type: DRUG

Other Intervention Names

Ceftaroline Fosamil; Teflaro

Eligibility Criteria

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Forest Laboratories

INDUSTRY

Sponsor Role: collaborator

Basim Asmar

OTHER

Sponsor Role: lead

Responsible Party

Basim Asmar

Professor of Pediatrics

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Children's Hospital of Michigan

Detroit, Michigan, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Basim Asmar, MD

Role: CONTACT

basmar@wayne.edu

313-745-5862

Facility Contacts

Basim Asmar, MD

Role: primary

basmar@wayne.edu

313-745-5862

Other Identifiers

CeftarolineCSF2013

Identifier Type: -

Identifier Source: org_study_id