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Search / Trial NCT04178629

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

Launched by AZIENDA SOCIO SANITARIA TERRITORIALE DEGLI SPEDALI CIVILI DI BRESCIA · Nov 25, 2019

Trial Information

Current as of July 06, 2025

Unknown status

Keywords

Ceftobiprole External Ventricular Derivation Cerebrospinal Fluid Penetration Atp Binding Cassette Transporter, Subfamily B, Member 1 Tissue Distribution

ClinConnect Summary

According with Inclusion and Exclusion criteria, patients with an EVD and concomitant ceftobiprole therapy will be enrolled in the study.

In particular, ceftobiprole will be prescribed by an expert infectivologist, in accordance with the MHRA guidelines.

Once the patients will be enrolled, Ceftobiprole will be administered by 2 hr i.v. infusion at the following dosage:

* normal renal function: 500mg every 8 hr
* mild renal impairment (50-80mL/min): 500mg every 8 hours
* moderate (30-49mL/min): 500mg every 12 hours
* severe (\<30mL/min): 250mg every 12 hours.

The following blood and CSF ...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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
  • Exclusion Criteria:
  • 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

About Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

The Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia is a leading healthcare organization based in Brescia, Italy, dedicated to providing high-quality medical services and promoting clinical research. As a prominent clinical trial sponsor, it focuses on advancing medical knowledge and improving patient care through innovative research initiatives. The institution integrates multidisciplinary expertise and state-of-the-art facilities to facilitate the development of new therapies and treatments, ensuring adherence to rigorous ethical and regulatory standards. With a commitment to enhancing public health, the Azienda plays a pivotal role in fostering collaborations among healthcare professionals, researchers, and industry partners.

Locations

Brescia, , Italy

Patients applied

0 patients applied

Trial Officials

Simone Piva

Principal Investigator

Università degli Studi di Brescia

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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