NCT07619625

Brief 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. 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
248

participants targeted

Target at P75+ for all trials

Timeline
30mo left

Started Jun 2026

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
Jun 2026Dec 2028

First Submitted

Initial submission to the registry

May 26, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 2, 2026

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2028

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

June 2, 2026

Status Verified

May 1, 2026

Enrollment Period

2.3 years

First QC Date

May 26, 2026

Last Update Submit

May 26, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    From the inclusion up to 30 days

Secondary Outcomes (2)

  • Occurrence of a contamination related to EVDs

    From the inclusion up to 30 days.

  • Occurrence of a colonisation related to EVDs

    From the inclusion up to 30 days.

Study Arms (1)

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

Interventions

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.

EVD-associated infection cohort in CIU and step-down care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cross Infection

Interventions

Nurses

Condition Hierarchy (Ancestors)

InfectionsIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health PersonnelHealth Care Facilities Workforce and Services

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2026

First Posted

June 2, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

June 2, 2026

Record last verified: 2026-05