NCT07067736

Brief Summary

The objective is to determine the concentration of cefazolin in the cerebrospinal fluid after a recommended antiobiotic prophylaxis by 2g of cefazolin. Our main hypothesis is that the concentration is insufficient to protect the valve from infections. The secondary objective is to compare our results to known pharmacokinetic models of cefazolin diffusion in the literature. If differences are found we would like to search clinical features that could explain it.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
2mo left

Started Aug 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress81%
Aug 2025Aug 2026

First Submitted

Initial submission to the registry

June 24, 2025

Completed
22 days until next milestone

First Posted

Study publicly available on registry

July 16, 2025

Completed
16 days until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2026

Last Updated

August 8, 2025

Status Verified

August 1, 2025

Enrollment Period

12 months

First QC Date

June 24, 2025

Last Update Submit

August 4, 2025

Conditions

HydrocephalyCSF ShuntsAntibiotic Prophylaxis

Keywords

Antibiotic prophylaxisCSF shuntsHydrocephaly

Outcome Measures

Primary Outcomes (1)

  • Cefazolin concentration in the cerebrospinal fluid

    Cefazolin concentration in the cerebrospinal fluid.

    The measure is made when the dura mater is opened just before the valve implantation.

Secondary Outcomes (4)

  • blood cefazolin concentration

    Blood samples are made before injection

  • blood cefazolin concentration

    Blood samples are made 30 minutes , after injection

  • blood cefazolin concentration

    Blood samples are made 1hour after injection

  • blood cefazolin concentration

    Blood samples are made 2 hours after injection

Study Arms (1)

Cefazolin antibiotic prophylaxis in ventricular shunt surgery

EXPERIMENTAL
Other: Cefazolin antibiotic prophylaxis

Interventions

Cefazolin antibiotic prophylaxisOTHER

Determination of cerebrospinal fluid concentration

Cefazolin antibiotic prophylaxis in ventricular shunt surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>18 years and programmed for a ventricular shunt surgery at the Hautepierre university hospital in Strasbourg.

You may not qualify if:

  • Age \<18 years old
  • Pregnant women
  • Infected patients
  • Known cefazolin allergy
  • Other molecule used for the antibiotic prophylaxis
  • Guardianship or conservatorship
  • Patients under curative antibiotherapy
  • Non sterile pre operative CSF
  • Refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

Hydrocephalus

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Baptiste BOUCHIER, MD

CONTACT

03.88.12.70.81baptiste.bouchier@chru-strasbourg.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2025

First Posted

July 16, 2025

Study Start

August 1, 2025

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

August 30, 2026

Last Updated

August 8, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)