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NCT Number: NCT07067736

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

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.

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Key information

Conditions

Hydrocephaly Antibiotic Prophylaxis Brain Diseases CSF Shunts Central Nervous System Diseases Hydrocephalus Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cefazolin antibiotic prophylaxis

Other

Determination of cerebrospinal fluid concentration

Primary outcomes

  1. Cefazolin concentration in the cerebrospinal fluid

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

    Cefazolin concentration in the cerebrospinal fluid.

Secondary outcomes

  1. blood cefazolin concentration

    Time frame: Blood samples are made before injection

    Compare the cerebrospinal and blood cefazolin concentration to the known pharmacokinetic models in order to determine clinical features that could explain thoses differences.

  2. blood cefazolin concentration

    Time frame: Blood samples are made 30 minutes , after injection

    Compare the cerebrospinal and blood cefazolin concentration to the known pharmacokinetic models in order to determine clinical features that could explain thoses differences.

  3. blood cefazolin concentration

    Time frame: Blood samples are made 1hour after injection

    Compare the cerebrospinal and blood cefazolin concentration to the known pharmacokinetic models in order to determine clinical features that could explain thoses differences.

  4. blood cefazolin concentration

    Time frame: Blood samples are made 2 hours after injection

    Compare the cerebrospinal and blood cefazolin concentration to the known pharmacokinetic models in order to determine clinical features that could explain thoses differences.

Study contacts

Contact information is provided by the study sponsor or research team.

Baptiste BOUCHIER, MD

CONTACT

[email protected]

03.88.12.70.81 ext. 0033

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

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

Acronym: CC -PIV

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 16, 2025
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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