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

NCT06720519 | Completed

• 2 other identifiers: QIA-ME2024/67 QIAMA
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Central nervous system infections; Bacterial Infection; Viral Infection; Meningitis; Encephalitis

Outcome Measures

Primary Outcomes (1)

• The analytical sensitivity of the multiparameter panel

  The analytical sensitivity of the test is assessed by comparing the results obtained with those known from routine diagnostic tests.

  6 months

Study Arms (1)

Positive Samples

Positive samples for viruses or bacteria typical of meningitis/encephalitis

Diagnostic Test: QIAstat-Dx®Meningitis/Encephalite Panel

Interventions

QIAstat-Dx®Meningitis/Encephalite Panel DIAGNOSTIC_TEST

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.

Positive Samples

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Virus or bacterial positive samples from cerebrospinal fluid.

You may qualify if:

• samples of CSF positive for virus and/or bacteria;
• Samples stored at -80°C, less than 5 years;
• Samples with a volume of at least 800μL.

You may not qualify if:

• Samples of a different matrix than CSF;
• Samples stored at room temperature;
• Samples for which diagnostic test results are not available;
• Samples with a volume of less than 800μL;
• Samples already thawed and refrozen.

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, 40138, Italy

Location

Related Publications (5)

• Penata A, Mesa S, Leal A, Castano T, Bustamante J, Sigifredo O. Molecular diagnosis of meningitis and meningoencephalitis with an automated real-time multiplex polymerase chain reaction in a tertiary reference complex in Medellin, Colombia. Rev Inst Med Trop Sao Paulo. 2020 Oct 9;62:e77. doi: 10.1590/S1678-9946202062077. eCollection 2020.

  PMID: 33053146 BACKGROUND

• Shin SY, Kwon KC, Park JW, Kim JM, Shin SY, Koo SH. Evaluation of the Seeplex(R) Meningitis ACE Detection kit for the detection of 12 common bacterial and viral pathogens of acute meningitis. Ann Lab Med. 2012 Jan;32(1):44-9. doi: 10.3343/alm.2012.32.1.44. Epub 2011 Dec 20.

  PMID: 22259778 BACKGROUND

• Messacar K, Breazeale G, Robinson CC, Dominguez SR. Potential clinical impact of the film array meningitis encephalitis panel in children with suspected central nervous system infections. Diagn Microbiol Infect Dis. 2016 Sep;86(1):118-20. doi: 10.1016/j.diagmicrobio.2016.05.020. Epub 2016 Jun 2.

  PMID: 27342782 BACKGROUND

• Leber AL, Everhart K, Balada-Llasat JM, Cullison J, Daly J, Holt S, Lephart P, Salimnia H, Schreckenberger PC, DesJarlais S, Reed SL, Chapin KC, LeBlanc L, Johnson JK, Soliven NL, Carroll KC, Miller JA, Dien Bard J, Mestas J, Bankowski M, Enomoto T, Hemmert AC, Bourzac KM. Multicenter Evaluation of BioFire FilmArray Meningitis/Encephalitis Panel for Detection of Bacteria, Viruses, and Yeast in Cerebrospinal Fluid Specimens. J Clin Microbiol. 2016 Sep;54(9):2251-61. doi: 10.1128/JCM.00730-16. Epub 2016 Jun 22.

  PMID: 27335149 BACKGROUND

• de Crom SC, Obihara CC, van Loon AM, Argilagos-Alvarez AA, Peeters MF, van Furth AM, Rossen JW. Detection of enterovirus RNA in cerebrospinal fluid: comparison of two molecular assays. J Virol Methods. 2012 Jan;179(1):104-7. doi: 10.1016/j.jviromet.2011.10.007. Epub 2011 Oct 15.

  PMID: 22024398 BACKGROUND

Related Links

• Emergency management in bacterial meningitis and sepsis: application of real time-polymerase chain reaction and FilmArray technology performed directly on cerebrospinal fluid and blood samples Authors Loria Bianchi
• Role of computed tomography before lumbar puncture: a survey of clinical practice

Biospecimen

Retention: SAMPLES WITH DNA

cerebrospinal fluid

MeSH Terms

Conditions

Central Nervous System Infections; Bacterial Infections; Virus Diseases; Meningitis; Encephalitis

Condition Hierarchy (Ancestors)

Infections; Central Nervous System Diseases; Nervous System Diseases; Bacterial Infections and Mycoses; Neuroinflammatory Diseases; Brain Diseases

Study Officials

• Liliana Gabrielli, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 6, 2024
• Study Start: April 17, 2024
• Primary Completion: October 17, 2024
• Study Completion: December 31, 2024
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)