Ceftaroline Diffusion Into Cerebrospinal Fluid of Children
1 other identifier
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Aug 2016
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 6, 2015
CompletedFirst Posted
Study publicly available on registry
November 9, 2015
CompletedStudy Start
First participant enrolled
August 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedOctober 4, 2018
October 1, 2018
3.3 years
November 6, 2015
October 2, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Arm 1
EXPERIMENTALSingle dose IV ceftaroline will be administered
Interventions
Following Ceftaroline single IV dose, 3 blood and cerbrospinal fluid samples will be collected
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Basim Asmarlead
- Forest Laboratoriescollaborator
Study Sites (1)
Children's Hospital of Michigan
Detroit, Michigan, 48201, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor of Pediatrics
Study Record Dates
First Submitted
November 6, 2015
First Posted
November 9, 2015
Study Start
August 1, 2016
Primary Completion
December 1, 2019
Study Completion
December 1, 2019
Last Updated
October 4, 2018
Record last verified: 2018-10