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

NCT ID: NCT06720519

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

170 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-17

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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The study is on biological samples of cerebrospinal fluid, positive for viruses or bacteria of interest, retrospective, monocentric, non-pharmacological.

For each sample included in the study (170 total samples), the molecular/culture test result, provided by the normal diagnostic process at the Microbiology Unit, is available for comparison with those obtained with the multiparameter panel QIAstat-Dx® Meningitis/Encephalitis (ME) and QIAstat-Dx 1.0 analyzer.

The aim of the study is:

1. To evaluate the analytical sensitivity of the test by identifying positive samples for bacteria (culture comparison) and positive samples for viruses (qPCR comparison).
2. Compare the value of Ct obtained with the number of viral copies per ml of cerebrospinal fluid obtained by qPCR.

Conditions

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Infections Nervous System

Keywords

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Central nervous system infections Bacterial Infection Viral Infection Meningitis Encephalitis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Positive Samples

Positive samples for viruses or bacteria typical of meningitis/encephalitis

QIAstat-Dx®Meningitis/Encephalite Panel

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 170 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.

Exclusion Criteria

* 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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Liliana Gabrielli, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Locations

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IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 33053146 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22259778 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27342782 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27335149 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22024398 (View on PubMed)

Related Links

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https://www.pagepressjournals.org/mm/article/view/5084

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

https://pmc.ncbi.nlm.nih.gov/articles/PMC2117486/

Role of computed tomography before lumbar puncture: a survey of clinical practice

Other Identifiers

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2024/67 QIAMA

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

QIA-ME

Identifier Type: -

Identifier Source: org_study_id