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OpenTrials
Completed

NCT Number: NCT02806882

Penetration of Ceftaroline Into Cerebrospinal Fluid(CSF)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CHU Dijon

Dijon, 21079, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ceftaroline fosamil

Drug

600mg IV infusion

Other names: ZINFORO

Primary outcomes

  1. Ceftaroline serum concentration

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

  2. Ceftaroline cerebrospinal fluid concentration

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Official study title

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

Acronym: Ceftaroline

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 21, 2016
Registry last updated
Feb 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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