Ceftobiprole's Cerebrospinal Fluid Penetration in Patients With External Ventricular Derivation (CEFTO-EVD)

NCT04178629 | Unknown DMC

• 1 other identifier: NP3617
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The Cerebrospinal fluid penetration of ceftobiprole has been studied in an animal model of meningitidis. Ceftobiprole is bactericidal, well tolerated and it has anti-biofilm activity. Altogether, these pharmacodynamics and pharmacokinetic properties of ceftobiprole are suitable for its use in case of External Ventricular Derivation(EVD)-related ventriculitis. Nowadays there are no human studies on the penetration and efficacy of ceftobiprole in the CSF. The study aims to evaluate characteristics of the CSF penetration of Ceftobiprole after intravenous administration in patients with EVD, that need for a concomitant infection this therapy (prescribed by an Infectious Diseases doctor).

Conditions

Pharmacokinetics; Cerebral Ventriculitis; Cephalosporins; Cerebrospinal Fluid

Keywords

Ceftobiprole; External Ventricular Derivation; Cerebrospinal fluid penetration; ATP Binding Cassette Transporter, Subfamily B, Member 1; Tissue Distribution

Outcome Measures

Primary Outcomes (1)

• Ceftobiprole's CSF penetration

  Evaluate the Cerebrospinal Fluid penetration of Ceftobiprole in patients with External Ventricular Derivation. Ceftobiprole concentrations (both in plasma/serum and CFS) will be analyzed with EMA fully validated LC-MS/MS methods.

  Blood samples: before infusion, end of infusion, then 30 minutes, 1 hour, 2 hours, 2,5 hours, 3 hours, 4 hours after end of administration; CSF samples: at the same time of blood samples, then at 6 hours, 8 hours and 10 hours after end of administration

Secondary Outcomes (2)

• Ceftobiprole's MDR1 role

  The MDR1 gene will be analyzed on whole blood samples, by real-time PCR, through study completion, an average of 18 months.

• Ceftobiprole's efficacy in CSF

  The measurement is assessed through study completion, an average of 18 months.

Eligibility Criteria

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

Study Population

Patient admitted in Intensive Care Unit or Neurosurgical Unit of Hospital "Spedali Civili di Brescia" (BS, Italy), according to Inclusion and Exclusion Criteria, with an EVD and concomitant Ceftobiprole therapy. When ceftobiprole will be administered i.v. for the first time, patients will be enrolled in the study.

You may qualify if:

• Age\>18
• Patients with External Ventricular Derivation (EVD)
• Patients who receive ceftobiprole for any infection where Ceftobiprole could be used, as judged by an expert infectivologist
• Patients or their relatives/parents who consent to study participation

You may not qualify if:

• Patients with end-stage renal insufficiency
• Patients with a BMI\>30
• Pregnancy
• Moribund patients
• Allergy to cephalosporine or ceftobiprole
• Refusal to participate in the study

Sponsors & Collaborators

• Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia: lead
• University of Turin, Italy: collaborator
• University of Pisa: collaborator
• Università degli Studi di Brescia: collaborator

Study Sites (1)

Spedali Civili di Brescia

Brescia, 25123, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

* Serum * Cerebrospinal Fluid

MeSH Terms

Conditions

Cerebral Ventriculitis

Condition Hierarchy (Ancestors)

Central Nervous System Viral Diseases; Central Nervous System Infections; Infections; Encephalitis; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases

Study Officials

• Simone Piva

  Università degli Studi di Brescia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simone Piva

CONTACT

+393332564230; simone.piva@unibs.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 15, 2019
• First Posted: November 26, 2019
• Study Start: July 2, 2019
• Primary Completion: November 1, 2020
• Study Completion: November 1, 2020
• Last Updated: November 26, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: already available

Locations

IT (1)