Cefazolin Antibiotic Prophylaxis in Ventricular Shunt Surgery: Determination of Cerebrospinal Fluid Concentration During Valve Implantation

NCT ID: NCT07067736

Last Updated: 2025-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-01

Study Completion Date

2026-08-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hydrocephaly CSF Shunts Antibiotic Prophylaxis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Cefazolin antibiotic prophylaxis in ventricular shunt surgery

Group Type EXPERIMENTAL

Cefazolin antibiotic prophylaxis

Intervention Type OTHER

Determination of cerebrospinal fluid concentration

Interventions

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Cefazolin antibiotic prophylaxis

Determination of cerebrospinal fluid concentration

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpitaux Universitaires de Strasbourg

Strasbourg, , France

Site Status

Countries

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France

Central Contacts

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Baptiste BOUCHIER, MD

Role: CONTACT

03.88.12.70.81 ext. 0033

Facility Contacts

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Baptiste BOUCHIER, MD

Role: primary

03.88.12.70.81 ext. 0033

Other Identifiers

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9720

Identifier Type: -

Identifier Source: org_study_id

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