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Molecular Panel Evaluation for Diagnosis of Infections of the Central Nervosous System

NCT06720519 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 170

Last updated 2025-12-18

No results posted yet for this study

Summary

Infections involving the central nervous system (CNS), such as meningitis/encephalitis (ME), are serious clinical conditions associated with high morbidity and mortality rates, as well as significant long-term consequences. ME can be caused by a wide variety of pathogenic agents. Clinical symptoms may vary and it has been shown that early identification of the pathogens causing ME allows for timely and appropriate treatment, thus reducing permanent neurological damage. The multiparameter panel "QIAstat-Dx®Meningitis/Encephalitis" can detect in one hour on a sample of 15 bacterial, viral and fungal pathogens. In the diagnostic routine, Real-time PCR takes an average of 3 hours and culture examination 2 days. In addition, compared to other comparable rapid molecular systems, the "QIAstat-Dx" platform has the ability to generate a cycle-related threshold value (Ct) for the targets detected. This value may have a correlation with the viral load and thus provide in a short time not only the result of positivity, but also an indication of the amount of virus present. Other commercially available multiparameter molecular tests provide only qualitative data.

Conditions

  • Infections Nervous System

Interventions

DIAGNOSTIC_TEST

QIAstat-Dx®Meningitis/Encephalite Panel

The analytical sensitivity of the test is assessed by comparing the results obtained with those known from routine diagnostic tests. For viruses only, the semi-quantitative value of Ct is also evaluated with the viral load provided by qPCR.

Sponsors & Collaborators

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    lead OTHER

Principal Investigators

  • Liliana Gabrielli, MD · IRCCS Azienda Ospedaliero-Universitaria di Bologna

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-17
Primary Completion
2024-10-17
Completion
2024-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06720519 on ClinicalTrials.gov