Open and exploratory trial to investigate the pharmacokinetic of ceftobiprole medocaril in patients with CSF device

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-003917-83-FR

Enrollment

Registered

2017-09-20

Start date

2017-08-16

Completion date

Unknown

Last updated

2020-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MedDRA version: 20.0 Level: PT Classification code 10027199 Term: Meningitis System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: Mabelio Product Name: Mabelio Pharmaceutical Form: Solution for infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Adult patients (> 18 years) o Provision of informed consent prior to any study specific procedures o 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 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 >103, elevated CSF protein, defined as CSF protein of >1g/l, reduced CSF glucose, defined as CSF glucose of 5 leukocytes/mm3 of CSF. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: - Hypersensitivity to MABELIO® (ceftobiprole) or to one of its excipient or another 3rd cephalosporin - Hypersensitivity to cephalosporin - Imeediate or severe hypersensitivity to ß-lactam antimicrovial - Pregnant or breast feeding women - Renal insufficiency defined as creatinine clearance 150 mL/min - patients with conditions known or suspected to alter pharmacokinetics (i.e., burn or cystic fibrosis patients) - refusal to participate - person not affiliated to the social security - person with antibacterial treatment

Design outcomes

Primary

Measure	Time frame
Main Objective: To characterize the PK of ceftobiprole after one intravenous infusion of ceftobiprole medocaril in patients with indwelling external CSF shunts who had suspected or documented meningitis or ventriculitis and to characterize the PK of ceftobiprole in the cerebrospinal fluid.;Secondary Objective: To evaluate the safety and tolerability of a single intravenous infusion of ceftobiprole medocaril (one 500 mg 2h-infusion) in patients with indwelling external CSF shunts. To characterize the PK of Ceftobiprole after a single intravenous infusion over 2 hours.;Primary end point(s):	—

Measure

Time frame

Main Objective: To characterize the PK of ceftobiprole after one intravenous infusion of ceftobiprole medocaril in patients with indwelling external CSF shunts who had suspected or documented meningitis or ventriculitis and to characterize the PK of ceftobiprole in the cerebrospinal fluid.;Secondary Objective: To evaluate the safety and tolerability of a single intravenous infusion of ceftobiprole medocaril (one 500 mg 2h-infusion) in patients with indwelling external CSF shunts. To characterize the PK of Ceftobiprole after a single intravenous infusion over 2 hours.;Primary end point(s):

—

Countries

France

Contacts

Public ContactChef de projets recherche

CHU de DIJON

maud.carpentier@chu-dijon.fr038029561833

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026