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RecruitingNCT07067736CC -PIVUpdated Aug 20, 2026

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

An interventional study of Cefazolin antibiotic prophylaxis in Hydrocephaly, CSF Shunts and Antibiotic Prophylaxis, sponsored by University Hospital, Strasbourg, France. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-20.

Sponsored by University Hospital, Strasbourg, France · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Started Feb 2026; still recruiting 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Hydrocephaly
  • CSF Shunts
  • Antibiotic Prophylaxis

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Keywords

  • Antibiotic prophylaxis
  • CSF shunts
  • Hydrocephaly
03

In context

Hydrocephalus

190 studies on the registry are indexed under Hydrocephalus; 52 are open to participants now.

This study's planned enrollment of 15 is below the median of 41 across 97 interventional studies indexed under Hydrocephalus.

Browse Hydrocephalus studies →

Lead sponsor

University Hospital, Strasbourg, France is the lead sponsor of 999 studies on the registry; 358 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • Experimental
    Cefazolin antibiotic prophylaxis in ventricular shunt surgery

    Other: Cefazolin antibiotic prophylaxis

Interventions

  • OtherCefazolin antibiotic prophylaxis

    Determination of cerebrospinal fluid concentration

06

What researchers measure

Primary outcomes

  1. Cefazolin concentration in the cerebrospinal fluid

    Cefazolin concentration in the cerebrospinal fluid.

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

Secondary outcomes

  1. blood cefazolin concentration

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

    Time frame: Blood samples are made before injection

  2. blood cefazolin concentration

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

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

  3. blood cefazolin concentration

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

    Time frame: Blood samples are made 1hour after injection

  4. blood cefazolin concentration

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

    Time frame: Blood samples are made 2 hours after injection

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2026 (actual). Primary completion is estimated for Aug 2026, 6 months after the start.

Of 40 interventional studies with no phase under Hydrocephalus, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 63. This study's planned 6 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 24, 2025
First posted
Jul 16, 2025
StartActual
Feb 1, 2026
Primary completionEst.
Aug 30, 2026
CompletionEst.
Aug 30, 2026
Last update
Aug 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07067736
Responsible party
Sponsor
First posted
Jul 16, 2025
Start date
Feb 1, 2026
Primary completion
Aug 30, 2026 (estimated)
Completion
Aug 30, 2026 (estimated)
Last update
Aug 20, 2026

Study contacts

Baptiste BOUCHIER, MD
Contact
baptiste.bouchier@chru-strasbourg.fr
03.88.12.70.81 ext. 0033

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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