Circulating Cell-Free DNA for Brain Abscess Diagnosis: A Pilot Study

NCT07479225 | Not Yet Recruiting

• 1 other identifier: 38RC24.0243
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief Summary

Brain abscess is a severe intracranial infection associated with significant morbidity and mortality. Standard management combines neurosurgical intervention, when feasible, with prolonged intravenous antibiotic therapy. Neurosurgical procedures, such as surgical drainage or stereotactic aspiration, play a key role in reducing intracranial pressure, decreasing the infectious burden, and obtaining samples for microbiological identification. However, neurosurgical intervention is not always possible due to technical limitations or patien related contrindications. In these situations, microbiological documentation becomes particularly challenging. Conventional diagnostic methods have limited sensitivity, with blood cultures and lumbar puncture yielding positive results in only about 25% of brain abscess cases. Recent advances in infectious disease diagnostics have introduced metagenomic approaches that may improve pathogen detection. Studies have shown that metagenomic analysis of operative samples can provide more comprehensive microbiological documentation than conventional culture-based methods. In addition, next-generation sequencing (NGS) of circulating microbial cell-free DNA in blood enables the detection of short microbial DNA fragments with a short half-life, reflecting active infection. This technology has already demonstrated promising results in clinical situations where microbiological documentation is difficult, such as febrile neutropenia. The present study aims to evaluate the performance of this approach in patients with brain abscess.

Conditions

Brain Abscess

Keywords

Brain Abscess; Cell-Free DNA; Metagenomics

Outcome Measures

Primary Outcomes (1)

• Blood and Brain Abscess Metagenomic Concordance

  Comparison of bacterial species identified by metagenomic next-generation sequencing of cell-free DNA (cfDNA) from blood samples versus metagenomic analysis of per-operative brain abscess samples.

  Day 0

Secondary Outcomes (3)

• Metagenomic Next-Generation Sequencing vs. Culture Concordance

  Day 0

• Plasma Cell-Free DNA vs. Abscess Culture Correlation

  Day 0

• Potential Clinical Impact on Antimicrobial Treatment

  At 1 Month

Study Arms (1)

Metagenomic Diagnostic Evaluation

EXPERIMENTAL

Diagnostic Test: Plasma Microbial Cell-Free DNA Metagenomic Sequencing

Interventions

Plasma Microbial Cell-Free DNA Metagenomic Sequencing DIAGNOSTIC_TEST

A 20 mL peripheral blood sample will be collected prior to neurosurgical intervention for metagenomic next-generation sequencing (mNGS) analysis of circulating microbial cell-free DNA. Results will be compared with metagenomic analysis and conventional culture of intraoperative brain abscess specimens, which serve as the reference standard for microbiological identification.

Metagenomic Diagnostic Evaluation

Eligibility Criteria

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

You may qualify if:

• Participant ≥ 18 years of age.
• Participant presenting with a brain abscess requiring neurosurgical
• Signed Informed Consent
• Covered by health insurance

You may not qualify if:

• Participant referred to in articles L1121-5 to L1121-8 of the CSP (corresponding to all protected persons : pregnant woman, parturient, breastfeeding mother, person deprived of liberty by judicial or administrative decision, persons undergoing psychiatric care under articles L.3212-1 and L.3213-1 who do not fall under article L.1121-8, persons admitted to a healthcare or social institution for purposes other than research, minors, person under legal protection or unable to express consent).
• Staff members with a hierarchical relationship to the principal investigator

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (2)

CHU de Grenoble Alpes, Laboratoire de bactériologie

Grenoble, France

Location

CHU de Grenoble Alpes, Service de réanimation neurochirurgicale

Grenoble, France

Location

MeSH Terms

Conditions

Brain Abscess

Condition Hierarchy (Ancestors)

Central Nervous System Infections; Infections; Abscess; Suppuration; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Marion LE MARECHAL, MD,PhD

CONTACT

04 76 76 52 91; MLemarechal@chu-grenoble.fr

Saber touati, PhD

CONTACT

04 76 76 58 05; stouati1@chu-grenoble.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2026
• First Posted: March 18, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

FR (2)