Penetration of Ceftaroline Into Cerebrospinal Fluid(CSF)

NCT02806882 | Completed Phase 1 DMC

• 1 other identifier: Chavanet AZ 2014
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Ceftaroline serum concentration

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

• Ceftaroline cerebrospinal fluid concentration

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

Study Arms (1)

Ceftaroline fosamil

EXPERIMENTAL

600mg 1 hour intravenous infusion ZINFORO

Drug: Ceftaroline fosamil

Interventions

Ceftaroline fosamil DRUG

600mg IV infusion

Also known as: ZINFORO

Ceftaroline fosamil

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

CHU Dijon

Dijon, 21079, France

Location

Related Publications (1)

• 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.

  PMID: 30535190 DERIVED

MeSH Terms

Conditions

Meningitis

Interventions

Ceftaroline

Condition Hierarchy (Ancestors)

Neuroinflammatory Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2016
• First Posted: June 21, 2016
• Study Start: April 29, 2015
• Primary Completion: October 24, 2016
• Study Completion: October 24, 2016
• Last Updated: February 21, 2024

Record last verified: 2024-02

Locations

FR (1)