Novel Diagnostic Methods to Identify External Ventricular Drain Associated Infections

NCT05904535 | Unknown

• 1 other identifier: K 2022-7809
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

External ventricular drain infections are difficult to identify with current diagnostic methods. Initiation of antibiotic treatment is usually supported by indirect methods of bacterial infection, such as clinical signs or cerebrospinal fluid cell counts (CSF). As such, excessive treatment with antibiotics is common in these patients due to suspected infection while the incidence of true culture confirmed infections are less common. This study will evaluate three novel diagnostic methods for rapid direct bacterial detection in CSF, in order to assess if these can be used to guide antibiotic treatment in neurocritically ill patients, compared to CSF bacterial cultures.

Conditions

Ventricular Drain Related Infection; Nosocomial Infection; Infection, Bacterial; Ventriculitis, Infectious

Outcome Measures

Primary Outcomes (1)

• Specificity

  Each methods specificity will be prospectively evaluated.

  2022-2025

Secondary Outcomes (1)

• Sensitivity

  2022-2025

Study Arms (1)

All patients

Cerebrospinal fluid will be collected from all study subjects and analyzed with sequencing techniques, Optotracing, and REDOX. All methods will compared with CSF bacterial cultures which is the current golden standard.

Other: Cerbrospinal fluid sampling.

Interventions

Cerbrospinal fluid sampling. OTHER

Routine sampling of cerebrospinal fluid from the proximal external ventricular drain port.

All patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with a minimum age of 18, who are admitted to the ICU and treated with an external ventricular drain. All patients will be included regardless of underlying admission diagnosis.

You may qualify if:

• Treated with an external ventricular drain.
• Admitted to the neurocritical and critical care unit at Karolinska University Hospital in Solna, Sweden.

You may not qualify if:

• \. Does not fulfill age requirements.

Sponsors & Collaborators

• Karolinska University Hospital: lead
• Region Stockholm: collaborator
• Karolinska Institutet: collaborator

Study Sites (1)

Perioperative Medicine and Intensive Care, Karolinska University Hospital

Stockholm, 17176, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Cerebrospinal fluid from external ventricular drains.

MeSH Terms

Conditions

Cross Infection; Bacterial Infections; Cerebral Ventriculitis

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bacterial Infections and Mycoses; Central Nervous System Viral Diseases; Central Nervous System Infections; Encephalitis; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases

Study Officials

• David W Nelson, MD, PhD

  Karolinska University Hospial, Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David W Nelson, MD, PhD

CONTACT

0851779168; david.nelson@ki.se

Marcus Bådholm, MD

CONTACT

0707761402; marcus.badholm@ki.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: June 15, 2023
• Study Start: September 21, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: June 15, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Up to 10 years after manuscript publication.
• Access Criteria: Shared upon reasonable request to study officials.

Locations

SE (1)