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

ConditionBrain Abscess
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Grenoble

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participant ≥ 18 years of age.

Participant presenting with a brain abscess requiring neurosurgical

Signed Informed Consent

Covered by health insurance

Disqualifiers

Participant in exclusion period for another study

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Metagenomic Diagnostic EvaluationExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
Day 0

Secondary outcomes

1

Metagenomic Next-Generation Sequencing vs. Culture Concordance

Evaluation of bacterial species identification using metagenomic next-generation sequencing compared to gold-standard culture techniques on per-operative brain abscess samples.

Time frame
Day 0
2

Plasma Cell-Free DNA vs. Abscess Culture Correlation

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

Time frame
Day 0
3

Potential Clinical Impact on Antimicrobial Treatment

Assessment of potential therapeutic modifications or antibiotic optimization induced by metagenomic next-generation sequencing results compared to standard culture-based diagnosis.

Time frame
At 1 Month

Other outcomes

Sponsors and contacts

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