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Penetration of Ceftaroline Into Cerebrospinal Fluid(CSF) (Ceftaroline)

Primary Purpose

Meningitis, Ventriculitis

Status

Unknown status

Phase

Phase 1

Locations

France

Study Type

Interventional

Intervention

Ceftaroline fosamil

About this trial

This is an interventional treatment trial for Meningitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Adult patients (≥ 18 years)
- Provision of informed consent prior to any study specific procedures
- Female patients of childbearing potential may be entered if pregnancy testing is negative and the patient agrees to abstain from procreational sexual intercourse or must use double-barrier contraceptive measures for the duration of the study
Presence of an indwelling external cerebrospinal fluid (CSF) access device (ventriculostomy or lumbar drain)
Presence of inflamed meninges as a result of documented or suspected meningitis or ventriculitis. Patients with both clinical symptoms (fever, headache, meningismus, and altered mentation) and laboratory parameters (CSF leukocytosis, defined as a CSF white blood cell count [WBC] of >10 3, elevated CSF protein, defined as CSF protein of >1g/l, reduced CSF glucose, defined as CSF glucose of <0.3g/l, or a positive CSF Gram stain or culture) indicative of CNS infection were deemed to have definitive bacterial meningitis/ventriculitis. Inflamed meninges were defined as the presence of >5 leukocytes/mm3 of CSF.

Exclusion Criteria:

Patient has documented history of hypersensitivity or allergic reaction (urticaria, angiooedema, anaphylaxis, desquamative rash) to any β-lactam antimicrobial including cephalosporins (contraindication to cephalosporins)
Patient is pregnant or lactating and intends to continue breastfeeding
Severe renal insufficiency defined as creatinine clearance < 50 mL/min.
Patients with conditions known or suspected to alter pharmacokinetics (i.e., burn or cystic fibrosis patients)
Refusal to participate
Person not affiliated with the social security

Sites / Locations

CHU DijonRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ceftaroline fosamil

Arm Description

600mg 1 hour intravenous infusion ZINFORO

Outcomes

Primary Outcome Measures

Ceftaroline serum concentration

Ceftaroline cerebrospinal fluid concentration

Secondary Outcome Measures

Full Information

NCT ID

NCT02806882

First Posted

June 14, 2016

Last Updated

June 16, 2016

Sponsor

Centre Hospitalier Universitaire Dijon

1. Study Identification

Unique Protocol Identification Number

NCT02806882

Brief Title

Penetration of Ceftaroline Into Cerebrospinal Fluid(CSF)

Acronym

Ceftaroline

Official Title

Open and Exploratory Trial to Investigate the Pharmacokinetic of Ceftaroline in Patients With CSF Device

Study Type

Interventional

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Unknown status

Study Start Date

April 2015 (undefined)

Primary Completion Date

April 2017 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Universitaire Dijon

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Ceftaroline is a piece of new cephalosporin very active on resistant staphylococci in methicillin (SEMR: Staphylococcus Epidermidis Resistant in Methicillin, SMAR: Staphylococcus Aureus Resistant in Methicillin)and/or in vancomycin ; Ceftaroline is also very active on pneumococci resistant in penicillin and/or 3rd generation of cephalosporins. Ceftaroline was approved by the European Medicines Agency for the treatment of complicated skin and soft tissue infections and community-acquired pneumonia. Scientific literature describes a good efficiency in septicemy and/or SAMR endocarditis. Besides, a study on animal shows the efficiency of ceftaroline in meningeal infections with gram-negative Bacilli. The rationale of this study is based on the antibacterial spectra of ceftaroline that could be used for the antibacterial treatment (curative and prophylactic) of CSF shunt associated infections. To validate this hypothesis, it is necessary to evaluate the concentration of ceftaroline in meningeal compartment after treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Meningitis, Ventriculitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Ceftaroline fosamil

Arm Type

Experimental

Arm Description

600mg 1 hour intravenous infusion ZINFORO

Intervention Type

Drug

Intervention Name(s)

Ceftaroline fosamil

Other Intervention Name(s)

ZINFORO

Intervention Description

600mg IV infusion

Primary Outcome Measure Information:

Title

Ceftaroline serum concentration

Time Frame

before infusion, at 0.5h, 1h, 3h, 6h, 12h, 24h after infusion

Title

Ceftaroline cerebrospinal fluid concentration

Time Frame

before infusion, at 0.5h, 1h, 3h, 6h, 12h, 24h after infusion

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adult patients (≥ 18 years) Provision of informed consent prior to any study specific procedures Female patients of childbearing potential may be entered if pregnancy testing is negative and the patient agrees to abstain from procreational sexual intercourse or must use double-barrier contraceptive measures for the duration of the study Presence of an indwelling external cerebrospinal fluid (CSF) access device (ventriculostomy or lumbar drain) Presence of inflamed meninges as a result of documented or suspected meningitis or ventriculitis. Patients with both clinical symptoms (fever, headache, meningismus, and altered mentation) and laboratory parameters (CSF leukocytosis, defined as a CSF white blood cell count [WBC] of >10 3, elevated CSF protein, defined as CSF protein of >1g/l, reduced CSF glucose, defined as CSF glucose of <0.3g/l, or a positive CSF Gram stain or culture) indicative of CNS infection were deemed to have definitive bacterial meningitis/ventriculitis. Inflamed meninges were defined as the presence of >5 leukocytes/mm3 of CSF. Exclusion Criteria: Patient has documented history of hypersensitivity or allergic reaction (urticaria, angiooedema, anaphylaxis, desquamative rash) to any β-lactam antimicrobial including cephalosporins (contraindication to cephalosporins) Patient is pregnant or lactating and intends to continue breastfeeding Severe renal insufficiency defined as creatinine clearance < 50 mL/min. Patients with conditions known or suspected to alter pharmacokinetics (i.e., burn or cystic fibrosis patients) Refusal to participate Person not affiliated with the social security

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Pascal MD CHAVANET

Phone

380293305

Ext

pascal.chavanet@chu-dijon.fr

Facility Information:

Facility Name

CHU Dijon

City

Dijon

ZIP/Postal Code

21079

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pascal Chavanet

Phone

380293305

Ext

pascal.chavanet@chu-dijon.fr

12. IPD Sharing Statement

Citations:

PubMed Identifier

30535190

Citation

Chauzy A, Nadji A, Combes JC, Defrance N, Bouhemad B, Couet W, Chavanet P. Cerebrospinal fluid pharmacokinetics of ceftaroline in neurosurgical patients with an external ventricular drain. J Antimicrob Chemother. 2019 Mar 1;74(3):675-681. doi: 10.1093/jac/dky489.

Results Reference

derived

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Penetration of Ceftaroline Into Cerebrospinal Fluid(CSF)

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