Ceftaroline Diffusion Into Cerebrospinal Fluid of Children | NCT02600793

Studies
Ceftaroline Diffusion Into Cerebrospinal Fluid of Children

NCT02600793

Sponsor

Basim Asmar

Status

Unknown status

Last Update Posted

Oct 4, 2018Actual

Enrollment

12Estimated

Phase

Phase 1

Conditions

Cerebrospinal Fluid Shunts
Ventriculoperitoneal Shunt

Interventions

Ceftaroline

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2016

Primary Completion Date

Dec 2019Estimated

Completion Date

Dec 2019Estimated

First Submitted Date

Nov 6, 2015

First Submission Date that Met QC Criteria

Nov 6, 2015

First Posted Date

Nov 9, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 2, 2018

Last Update Posted Date

Oct 4, 2018Actual

Name	Class
Forest Laboratories	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1	Experimental	Single dose IV ceftaroline will be administered	Drug: Ceftaroline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ceftaroline	Drug	Following Ceftaroline single IV dose, 3 blood and cerbrospinal fluid samples will be collected	Arm 1

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Months

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Basim Asmar, MD	Contact	313-745-5862		basmar@wayne.edu

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's Hospital of Michigan	Recruiting	Detroit	Michigan	48201	United States

Intervention Browse Module

MeSH Terms

ID	Term
D000097583	Ceftaroline

Ancestor Terms

ID	Term
D002511	Cephalosporins
D047090	beta-Lactams
D007769	Lactams
D000577	Amides
D009930

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