Penetration of Ceftaroline Into Cerebrospinal Fluid(CSF)

NCT ID: NCT02806882

Last Updated: 2024-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-29
• Study Completion Date: 2016-10-24

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.

Conditions

Meningitis; Ventriculitis

Study Design

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

Study Groups

Ceftaroline fosamil

600mg 1 hour intravenous infusion ZINFORO

Group Type: EXPERIMENTAL

Ceftaroline fosamil

Intervention Type: DRUG

600mg IV infusion

Interventions

Ceftaroline fosamil

600mg IV infusion

Intervention Type: DRUG

Other Intervention Names

ZINFORO

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Dijon

Dijon, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 30535190 (View on PubMed)

Other Identifiers

Chavanet AZ 2014

Identifier Type: -

Identifier Source: org_study_id