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Ceftaroline Diffusion Into Cerebrospinal Fluid of Children

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ClinicalTrials.gov Identifier: NCT02600793
Recruitment Status : Unknown
Verified October 2018 by Basim Asmar, Wayne State University.
Recruitment status was:  Recruiting
First Posted : November 9, 2015
Last Update Posted : October 4, 2018
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Basim Asmar, Wayne State University

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.

Condition or disease Intervention/treatment Phase
Cerebrospinal Fluid Shunts Ventriculoperitoneal Shunt Drug: Ceftaroline Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ceftaroline Diffusion Into Cerebrospinal Fluid of Children With Ventriculitis Due to Ventriculoperitoneal Shunt (VPS) Infection
Study Start Date : August 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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:
  • Ceftaroline Fosamil
  • Teflaro




Primary Outcome Measures :
  1. Pharmacokinetic assessment of Ceftaroline diffusion from blood into the Cerbrospinal fluid. [ Time Frame: 8 hours ]
    Serial collection of three blood and three cerbrospinal fluid sample over 8 hours



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Ages Eligible for Study:   6 Months to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02600793


Contacts
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Contact: Basim Asmar, MD 313-745-5862 basmar@wayne.edu

Locations
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United States, Michigan
Children's Hospital of Michigan Recruiting
Detroit, Michigan, United States, 48201
Contact: Basim Asmar, MD    313-745-5862    basmar@wayne.edu   
Sponsors and Collaborators
Basim Asmar
Forest Laboratories
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Responsible Party: Basim Asmar, Professor of Pediatrics, Wayne State University
ClinicalTrials.gov Identifier: NCT02600793    
Other Study ID Numbers: CeftarolineCSF2013
First Posted: November 9, 2015    Key Record Dates
Last Update Posted: October 4, 2018
Last Verified: October 2018
Additional relevant MeSH terms:
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Ceftaroline fosamil
Anti-Bacterial Agents
Anti-Infective Agents