Health Care Associated InfectionCLEAN-EVDNCT07619625
Care Bundle to Limit External Ventricular Drain Associated iNfections
An observational study of Health Care Associated Infection, run by Centre Hospitalier Universitaire de Nice.
Trial summary
The aim of our study is to reduce the incidence of External ventricular drain (EVD)-related infections by implementing a bundle of measures including updated care protocoles and training of residents, nurses and nurses assistants. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Care Associated Infection
- What is being tested?
- Bundle of measures including updated care protocoles and training of residents, nurses and nurses assistants
- How many people
- 248 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 1 Dec 2028
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population consists of adult patients admitted to the general intensive care and intermediate care units of Nice University Hospital who underwent EVD placement on site.
Who may be able to join
- Age ≥ 18 years.
- Hospitalized in a general intensive care unit or intermediate care unit at Nice University Hospital.
- Having undergone EVD placement within the institution.
Who cannot join
- EVD placed outside the institution with no possibility of follow-up.
- Patient under immediate therapeutic limitation.
- Pre-existing neuromeningeal infection.
- Expression by the patient or by the trusted person of opposition to the processing of the patient's medical data.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The aim of our study is to reduce the incidence of External ventricular drain (EVD)-related infections by implementing a bundle of measures including updated care protocoles and training of residents, nurses and nurses assistants. At Nice University Hospital, we are conducting a retrospective study showing a 22% infection rate associated with EVD. The identified pathogens are mainly transmitted by manual contact. Additionnally, high turnover among paramedical staff and sometimes rapid training may contribute to infection ocurrence. We hypothesize that a significant proportion of patients with EVD develop nosocomial ventriculitis, primarily due to modificable risk factors such as catheter handling and breaches in aseptic technique.
- Conditions
- Health Care Associated Infection
- Being tested
- Bundle of measures including updated care protocoles and training of residents, nurses and nurses assistants
- Medical subject headings
- Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bundle of measures including updated care protocoles and training of residents, nurses and nurses assistantsOther
Preventive measures are structured around several key areas : updating the EVD insertion protocol and the EVD care protocol, optimizing dressing changes and scalp cleansing ; ; creation of reminder signage displayed outside the rooms of patients with an EVD outlining key hygiene rules ; implementation of theoretical teaching and simulation sessions for residents and nurses, covering EVD management, infectious complications, their treatment, and prevention ; assessment through a questionnaire on EVD management before implementation of preventive measures and after.
| Study group | Role | What they receive |
|---|---|---|
| EVD-associated infection cohort in CIU and step-down care | Not described Receives: Other: Bundle of measures including updated care protocoles and training of residents, nurses and nurses assistants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of an infection related to EVDs between the day of insertion and up to 30 daysafterward.
Number of infections according to the 2017. Altération de la biochimie du LCR. Clinical deterioration of the patient
Measured: From the inclusion up to 30 days
Secondary outcomes (2)
Occurrence of a contamination related to EVDs
Number of contamination according to : CSF with a single positive culture or a direct examination with Gram staining showing a microorganism, without any alteration in CSF biochemistry and without clinical deterioration. CSF contamination corresponds to the detection of microorganisms in a CSF sample that do not originate from the site being studied (CSF).
Measured: From the inclusion up to 30 days.
Occurrence of a colonisation related to EVDs
Number of colonisation according to CSF with multiple positive cultures or multiple direct examinations with Gram staining showing a microorganism, without any alteration in CSF biochemistry and without clinical deterioration. CSF colonization corresponds to the presence of microorganisms in the CSF without any associated clinical manifestations.
Measured: From the inclusion up to 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Care Associated InfectionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 248 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07619625
- Sponsor's protocol ID
- 26Anesthesie-Réa
- Acronym
- CLEAN-EVD
- Status last verified
- May 2026
- First submitted
- 26 May 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Care Bundle to Limit External Ventricular Drain Associated iNfections
- ClinicalTrials.gov ID
- NCT07619625
- Acronym / sponsor ID
- CLEAN-EVD / 26Anesthesie-Réa
- Conditions
- Health Care Associated Infection
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 248 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 2 Jun 2026 (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 aim of our study is to reduce the incidence of External ventricular drain (EVD)-related infections by implementing a bundle of measures including updated care protocoles and training of residents, nurses and nurses assistants. At Nice University Hospital, we are conducting a retrospective study showing a 22% infection rate associated with EVD. The identified pathogens are mainly transmitted by manual contact. Additionnally, high turnover among paramedical staff and sometimes rapid training may contribute to infection ocurrence. We hypothesize that a significant proportion of patients with EVD develop nosocomial ventriculitis, primarily due to modificable risk factors such as catheter handling and breaches in aseptic technique.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EVD-associated infection cohort in CIU and step-down care | – | Other: Bundle of measures including updated care protocoles and training of residents, nurses and nurses assistants |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients admitted to the general intensive care and intermediate care units of Nice University Hospital who underwent EVD placement on site.
Key inclusion criteria (3 listed)
- Age ≥ 18 years.
- Hospitalized in a general intensive care unit or intermediate care unit at Nice University Hospital.
- Having undergone EVD placement within the institution.
Key exclusion criteria (4 listed)
- EVD placed outside the institution with no possibility of follow-up.
- Patient under immediate therapeutic limitation.
- Pre-existing neuromeningeal infection.
- Expression by the patient or by the trusted person of opposition to the processing of the patient's medical data.
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 |
|---|---|---|
| Bundle of measures including updated care protocoles and training of residents, nurses and nurses assistantsPreventive measures are structured around several key areas : updating the EVD insertion protocol and the EVD care protocol, optimizing dressing changes and scalp cleansing ; ; creation of reminder signage displayed outside the rooms of patients with an EVD outlining key hygiene rules ; implementation of theoretical teaching and simulation sessions for residents and nurses, covering EVD management, infectious complications, their treatment, and prevention ; assessment through a questionnaire on EVD management before implementation of preventive measures and after. | Other | EVD-associated infection cohort in CIU and step-down care |
Primary outcome
Occurrence of an infection related to EVDs between the day of insertion and up to 30 daysafterward.
Time frame: From the inclusion up to 30 days
Number of infections according to the 2017. Altération de la biochimie du LCR. Clinical deterioration of the patient
2 secondary outcomes
Occurrence of a contamination related to EVDs
Time frame: From the inclusion up to 30 days.
Occurrence of a colonisation related to EVDs
Time frame: From the inclusion up to 30 days.
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 2 Jun 2026.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Health Care Associated Infection, run by Centre Hospitalier Universitaire de Nice.
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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Julie Borovik (06 98 86 83 50, borovik.j@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of an infection related to EVDs between the day of insertion and up to 30 daysafterward. (time frame: From the inclusion up to 30 days). 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 2 Jun 2026.