HydrocephalyCC -PIVNCT07067736
Cefazolin Antibiotic Prophylaxis in Ventricular Shunt Surgery: Determination of Cerebrospinal Fluid Concentration During Valve Implantation
A study testing Cefazolin antibiotic prophylaxis in people with Hydrocephaly and CSF Shunts, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hydrocephaly, CSF Shunts, Antibiotic Prophylaxis
- What is being tested?
- Cefazolin antibiotic prophylaxis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2026to 30 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years and programmed for a ventricular shunt surgery at the Hautepierre university hospital in Strasbourg.
Who cannot join
- Age <18 years old
- Pregnant women
- Infected patients
- Known cefazolin allergy
- Other molecule used for the antibiotic prophylaxis
- Guardianship or conservatorship
Show all 9Show fewer
- Patients under curative antibiotherapy
- Non sterile pre operative CSF
- Refusal to participate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
Baptiste BOUCHIER, MD, 03.88.12.70.81 ext. 0033, baptiste.bouchier@chru-strasbourg.fr
About this study
Official title: Cefazolin Antibiotic Prophylaxis in Ventricular Shunt Surgery: Determination of Cerebrospinal Fluid(CSF) 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.
- Conditions
- Hydrocephaly, CSF Shunts, Antibiotic Prophylaxis
- Being tested
- Cefazolin antibiotic prophylaxis
- Keywords
- Antibiotic prophylaxis, CSF shunts, Hydrocephaly
- Medical subject headings
- Hydrocephalus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cefazolin antibiotic prophylaxisOther
Determination of cerebrospinal fluid concentration
| Study group | Role | What they receive |
|---|---|---|
| Cefazolin antibiotic prophylaxis in ventricular shunt surgery | Experimental | Not described Receives: Other: Cefazolin antibiotic prophylaxis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cefazolin concentration in the cerebrospinal fluid
Cefazolin concentration in the cerebrospinal fluid.
Measured: The measure is made when the dura mater is opened just before the valve implantation.
Secondary outcomes (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.
Measured: Blood samples are made before injection
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.
Measured: Blood samples are made 30 minutes , after injection
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.
Measured: Blood samples are made 1hour after injection
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.
Measured: Blood samples are made 2 hours after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start1 Feb 2026
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HydrocephalyStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07067736
- Sponsor's protocol ID
- 9720
- Acronym
- CC -PIV
- Status last verified
- Aug 2026
- First submitted
- 24 Jun 2025
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cefazolin Antibiotic Prophylaxis in Ventricular Shunt Surgery: Determination of Cerebrospinal Fluid(CSF) Concentration During Valve Implantation
- ClinicalTrials.gov ID
- NCT07067736
- Acronym / sponsor ID
- CC -PIV / 9720
- Conditions
- Hydrocephaly, CSF Shunts, Antibiotic Prophylaxis
- Keywords
- Antibiotic prophylaxis, CSF shunts, Hydrocephaly
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 16 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cefazolin antibiotic prophylaxis in ventricular shunt surgery | Experimental | Other: Cefazolin antibiotic prophylaxis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age >18 years and programmed for a ventricular shunt surgery at the Hautepierre university hospital in Strasbourg.
Key exclusion criteria (9 listed)
- Age <18 years old
- Pregnant women
- Infected patients
- Known cefazolin allergy
- Other molecule used for the antibiotic prophylaxis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cefazolin antibiotic prophylaxisDetermination of cerebrospinal fluid concentration | Other | Cefazolin antibiotic prophylaxis in ventricular shunt surgery |
Primary outcome
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.
4 secondary outcomes
blood cefazolin concentration
Time frame: Blood samples are made before injection
blood cefazolin concentration
Time frame: Blood samples are made 30 minutes , after injection
blood cefazolin concentration
Time frame: Blood samples are made 1hour after injection
blood cefazolin concentration
Time frame: Blood samples are made 2 hours after injection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cefazolin antibiotic prophylaxis in people with Hydrocephaly and CSF Shunts, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Baptiste BOUCHIER, MD (03.88.12.70.81 ext. 0033, baptiste.bouchier@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cefazolin concentration in the cerebrospinal fluid (time frame: The measure is made when the dura mater is opened just before the valve implantation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.