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

Phase 1

• Conditions: MedDRA version: 20.0Level: PTClassification code 10027199Term: MeningitisSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2016-003917-83-FR
• Lead Sponsor: CHU de DIJO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-09-20
• Last Update Posted: 21 September 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 10

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 <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.
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

- 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 < 50 mL/min
- Patient with 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>To characterize the PK of Ceftobiprole after a single intravenous infusion over 2 hours.;Primary end point(s):