MeningitisNCT07432113
Prediction of Infectious Agents in the Biofire® FilmArray bioMérieux Meningitis/Encephalitis Panel Based on Clinical Syndrome and Cerebrospinal Fluid Parameters: a Diagnostic Stewardship Proposal.
A study testing Biofire FilmArray Meningitis/Encephalitis Panel in people with Meningitis and Encephalitic Infection, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
Trial summary
Background: Infections of the central nervous system (CNS) are associated with high morbidity, mortality, and high resource consumption. The BioFire FilmArray is a molecular diagnostic panel capable of identifying 14 pathogens in approximately one hour, including bacteria, viruses, and fungi. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meningitis, Encephalitic Infection, Encephalitis
- What is being tested?
- Biofire FilmArray Meningitis/Encephalitis Panel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteBrazil
- Study dates
- 13 Apr 2026to 31 Oct 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 years or older, of any gender.
- Presence of at least two of the following symptoms: fever, lethargy, altered level of consciousness, seizures, acute focal deficit, signs of meningeal irritation, or headache.
- Symptoms must have started within the last 30 days.
- Obligatory presence of pleocytosis (CSF white blood cell count ≥ 5 cells/mm³).
- Provision of written Informed Consent (TCLE) by the patient or their legal representative.
Who cannot join
- Failure to sign the Informed Consent Form.
- Clinical manifestations lasting more than 30 days.
- Patients under 18 years of age.
- Patients who have undergone neurosurgery within 30 days prior to the onset of symptoms (applies to both prospective and control groups).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Irmandande Santa Casa de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90020-090
Alessandro C Pasqualotto, PhD, +55 51 999951614, pasqualotto@ufcspa.edu.br
Candida Driemeyer, MD, +5551998793442, driemeyer@ufcspa.edu.br
About this study
Background: Infections of the central nervous system (CNS) are associated with high morbidity, mortality, and high resource consumption. The BioFire FilmArray is a molecular diagnostic panel capable of identifying 14 pathogens in approximately one hour, including bacteria, viruses, and fungi. However, it is not yet widely available in the Brazilian public health system.
Objective: The primary objective of this study is to evaluate the pre-test probability of positivity of the Biofire FilmArray bioMérieux Meningitis/Encephalitis panel in patients with clinical syndrome of meningitis and/or encephalitis and pleocytosis (CSF ≥ 5 cells).
Read more
As secondary objectives, the study aims to:
Determine the clinical impact of using the panel through variables such as total hospital stay and length of stay in the intensive care unit.
Compare the duration of antibiotic use in non-bacterial cases between groups. Compare the time to reduction of acyclovir use in etiologies without proven benefit.
Compare the time for identification of the causative pathogen and mortality rates between the study groups.
Perform a cost-effectiveness analysis of the test. Compare the request for imaging exams, such as brain MRI and CT scan, between the groups.
Methods: This is a prospective, transversal, and multicenter study conducted at Santa Casa de Porto Alegre and Hospital Dom João Becker. Patients will be compared with a retrospective cohort used as a control group.
Read the detailed description
This will be a prospective study, conducted at Santa Casa de Porto Alegre, a philanthropic tertiary university hospital with 1,400 beds and at Hospital Dom João Becker, which has 173 inpatient beds and 20 ICU beds. Adult patients with clinical symptoms compatible with CNS infection that began less than 30 days prior, for whom cerebrospinal fluid collection has been indicated by the attending physician, will be included. Participation in the study will be subject to the signing of an informed consent form (ICF) by the patient or their legal representative. The patient will then be included in the study. Samples will be processed with qualitative and quantitative cytology, protein, glucose, and lactate analysis, as well as specific tests as requested by the attending physician. Patients will be compared with a retrospective cohort used as a control group (patients with clinical CNS infection who underwent cerebrospinal fluid collection but were not tested with the FilmArray panel) over the past 4 years.
- Conditions
- Meningitis, Encephalitic Infection, Encephalitis, Meningitis, Fungal, Meningitis, Viral, Meningitis, Bacterial
- Being tested
- Biofire FilmArray Meningitis/Encephalitis Panel
- Keywords
- filmarray, biofire, biofire filmarray, meningits, encephalitis
- Medical subject headings
- Meningitis, Encephalitis, Meningitis, Fungal, Meningitis, Viral, Meningitis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biofire FilmArray Meningitis/Encephalitis PanelDiagnostic test
The Biofire FilmArray is a multiplex molecular diagnostic test that will be performed on 0.2 mL of cerebrospinal fluid (CSF) collected from patients via lumbar or suboccipital puncture. The system automatically performs DNA/RNA extraction, purification, multiplex PCR, and identification of 14 different pathogens (6 bacteria, 7 viruses, and 1 fungus). The complete process takes approximately one hour and provides qualitative results to guide therapeutic decisions such as antibiotic stewardship.
| Study group | Role | What they receive |
|---|---|---|
| Biofire FilmArray group | Experimental | Patients with clinical suspicion of CNS infection and pleocytosis (CSF ≥ 5 cells/mm³) who will be prospectively tested using the BioFire FilmArray Meningitis/Encephalitis panel Receives: Diagnostic Test: Biofire FilmArray Meningitis/Encephalitis Panel |
| Retrospective Control Group | No intervention | A retrospective cohort of patients from the last four years who presented with similar clinical syndromes and CSF pleocytosis (≥ 5 cells/mm³) but were managed with standard care without molecular panel testing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of BioFire® FilmArray® Meningitis/Encephalitis Panel Positivity
Proportion of positive BioFire® FilmArray® Meningitis/Encephalitis panel results among participants presenting with a clinical syndrome of meningitis and/or encephalitis and cerebrospinal fluid pleocytosis (≥ 5 cells/mm³).
Measured: At the time of BioFire® FilmArray® result availability, assessed up to 24 months
Secondary outcomes (9)
Total hospital length of stay in days
Duration of hospitalization, measured in days, compared between study groups.
Measured: From hospital admission until hospital discharge or death, whichever occurs first, assessed up to 24 months.
Intensive care unit length of stay in days
Duration of intensive care unit stay, measured in days, compared between study groups.
Measured: From intensive care unit admission until intensive care unit discharge or death, whichever occurs first, assessed up to 24 months.
Duration of antibiotic therapy in participants without confirmed bacterial infection
Duration of systemic antibiotic therapy, measured in days, compared between study groups in participants without confirmed bacterial etiology.
Measured: From antibiotic initiation until discontinuation, hospital discharge, or death, whichever occurs first, assessed up to 24 months.
Duration of acyclovir therapy in participants without confirmed indication
Duration of acyclovir therapy, measured in days, compared between study groups in participants without confirmed indication of benefit.
Measured: From acyclovir initiation until discontinuation, hospital discharge, or death, whichever occurs first, assessed up to 24 months.
Time to pathogen identification
Time, measured in days, from diagnostic testing to identification of an infectious pathogen, compared between study groups when a pathogen is detected.
Measured: From cerebrospinal fluid collection until pathogen identification, when available, assessed up to 24 months.
In-hospital mortality
Occurrence of death during hospitalization, compared between study groups.
Measured: From hospital admission until death or hospital discharge, whichever occurs first, assessed up to 24 months.
Need for hemodialysis
Requirement for hemodialysis at any time during hospitalization, compared between study groups.
Measured: From hospital admission until hospital discharge or death, whichever occurs first, assessed up to 24 months.
Direct medical costs
Direct medical costs associated with hospitalization and therapeutic interventions, compared between study groups.
Measured: From hospital admission until hospital discharge or death, whichever occurs first, assessed up to 24 months.
Use of neuroimaging
Performance of at least one brain magnetic resonance imaging or computed tomography scan during hospitalization, compared between study groups.
Measured: From hospital admission until hospital discharge or death, whichever occurs first, assessed up to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start13 Apr 2026
- Primary completion16 Mar 2028 (estimated)
- Study completion31 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for MeningitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The data obtained in the prospective arm of the study will be compared with those of a control group formed by a retrospective cohort of patients hospitalized in the last four years, with compatible clinical syndrome and liquid containing hair less than 5 cells. These data are previously collected as part of routine medical care and are recorded in the medical records of the participating institutions. There will be no direct interaction with the participants and no additional collection of information or biological materials.
- Masking
- None (open label)
- Enrolment
- 182 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Health Science of Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Irmandade Santa Casa de Misericórdia de Porto Alegre, BioMérieux
- Responsible party
- Principal investigator, Alessandro Pasqualotto, Federal University of Health Science of Porto Alegre
- Investigators
- Alessandro C Pasqualotto, PhD, Study chair, Federal University of Health Sciences of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07432113
- Sponsor's protocol ID
- 88825625.5.0000.5335
- Other IDs
- U1111-1334-6700
- Status last verified
- Aug 2026
- First submitted
- 1 Feb 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to ensure strict compliance with the Brazilian General Data Protection Law (LGPD) and to protect the privacy of participants, especially those from the retrospective cohort for whom a waiver of informed consent was granted due to the impossibility of contact.
Publications
Cailleaux M, Pilmis B, Mizrahi A, Lourtet-Hascoet J, Nguyen Van JC, Alix L, Couzigou C, Vidal B, Tattevin P, Le Monnier A. Impact of a multiplex PCR assay (FilmArray(R)) on the management of patients with suspected central nervous system infections. Eur J Clin Microbiol Infect Dis. 2020 Feb;39(2):293-297. doi: 10.1007/s10096-019-03724-7. Epub 2019 Nov 12.
PubMed 31720944Duff S, Hasbun R, Balada-Llasat JM, Zimmer L, Bozzette SA, Ginocchio CC. Economic analysis of rapid multiplex polymerase chain reaction testing for meningitis/encephalitis in adult patients. Infection. 2019 Dec;47(6):945-953. doi: 10.1007/s15010-019-01320-7. Epub 2019 May 20.
PubMed 31111325Soucek DK, Dumkow LE, VanLangen KM, Jameson AP. Cost Justification of the BioFire FilmArray Meningitis/Encephalitis Panel Versus Standard of Care for Diagnosing Meningitis in a Community Hospital. J Pharm Pract. 2019 Feb;32(1):36-40. doi: 10.1177/0897190017737697. Epub 2017 Nov 1.
PubMed 29092659Trujillo-Gomez J, Tsokani S, Arango-Ferreira C, Atehortua-Munoz S, Jimenez-Villegas MJ, Serrano-Tabares C, Veroniki AA, Florez ID. Biofire FilmArray Meningitis/Encephalitis panel for the aetiological diagnosis of central nervous system infections: A systematic review and diagnostic test accuracy meta-analysis. EClinicalMedicine. 2022 Feb 14;44:101275. doi: 10.1016/j.eclinm.2022.101275. eCollection 2022 Feb.
PubMed 35198914
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Infectious Agents in the Biofire® FilmArray bioMérieux Meningitis/Encephalitis Panel Based on Clinical Syndrome and Cerebrospinal Fluid Parameters: a Diagnostic Stewardship Proposal.
- ClinicalTrials.gov ID
- NCT07432113
- Acronym / sponsor ID
- 88825625.5.0000.5335
- Conditions
- Meningitis, Encephalitic Infection, Encephalitis, Meningitis, Fungal, Meningitis, Viral, Meningitis, Bacterial
- Keywords
- filmarray, biofire, biofire filmarray, meningits, encephalitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- Federal University of Health Science of Porto AlegreUniversity, hospital or other
- Collaborators
- Irmandade Santa Casa de Misericórdia de Porto Alegre, BioMérieux
- Study start
- 13 Apr 2026 (actual)
- Primary completion
- 16 Mar 2028 (estimated)
- Study completion
- 31 Oct 2029 (estimated)
- First posted
- 25 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Infections of the central nervous system (CNS) are associated with high morbidity, mortality, and high resource consumption. The BioFire FilmArray is a molecular diagnostic panel capable of identifying 14 pathogens in approximately one hour, including bacteria, viruses, and fungi. However, it is not yet widely available in the Brazilian public health system.
Objective: The primary objective of this study is to evaluate the pre-test probability of positivity of the Biofire FilmArray bioMérieux Meningitis/Encephalitis panel in patients with clinical syndrome of meningitis and/or encephalitis and pleocytosis (CSF ≥ 5 cells).
As secondary objectives, the study aims to:
Determine the clinical impact of using the panel through variables such as total hospital stay and length of stay in the intensive care unit.
Compare the duration of antibiotic use in non-bacterial cases between groups. Compare the time to reduction of acyclovir use in etiologies without proven benefit.
Compare the time for identification of the causative pathogen and mortality rates between the study groups.
Perform a cost-effectiveness analysis of the test. Compare the request for imaging exams, such as brain MRI and CT scan, between the groups.
Methods: This is a prospective, transversal, and multicenter study conducted at Santa Casa de Porto Alegre and Hospital Dom João Becker. Patients will be compared with a retrospective cohort used as a control group.
Detailed description
This will be a prospective study, conducted at Santa Casa de Porto Alegre, a philanthropic tertiary university hospital with 1,400 beds and at Hospital Dom João Becker, which has 173 inpatient beds and 20 ICU beds. Adult patients with clinical symptoms compatible with CNS infection that began less than 30 days prior, for whom cerebrospinal fluid collection has been indicated by the attending physician, will be included. Participation in the study will be subject to the signing of an informed consent form (ICF) by the patient or their legal representative. The patient will then be included in the study. Samples will be processed with qualitative and quantitative cytology, protein, glucose, and lactate analysis, as well as specific tests as requested by the attending physician. Patients will be compared with a retrospective cohort used as a control group (patients with clinical CNS infection who underwent cerebrospinal fluid collection but were not tested with the FilmArray panel) over the past 4 years.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The data obtained in the prospective arm of the study will be compared with those of a control group formed by a retrospective cohort of patients hospitalized in the last four years, with compatible clinical syndrome and liquid containing hair less than 5 cells. These data are previously collected as part of routine medical care and are recorded in the medical records of the participating institutions. There will be no direct interaction with the participants and no additional collection of information or biological materials.
| Arm | Type | Receives |
|---|---|---|
| Biofire FilmArray group | Experimental | Diagnostic Test: Biofire FilmArray Meningitis/Encephalitis PanelPatients with clinical suspicion of CNS infection and pleocytosis (CSF ≥ 5 cells/mm³) who will be prospectively tested using the BioFire FilmArray Meningitis/Encephalitis panel |
| Retrospective Control Group | No intervention | –A retrospective cohort of patients from the last four years who presented with similar clinical syndromes and CSF pleocytosis (≥ 5 cells/mm³) but were managed with standard care without molecular panel testing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 18 years or older, of any gender.
- Presence of at least two of the following symptoms: fever, lethargy, altered level of consciousness, seizures, acute focal deficit, signs of meningeal irritation, or headache.
- Symptoms must have started within the last 30 days.
- Obligatory presence of pleocytosis (CSF white blood cell count ≥ 5 cells/mm³).
- Provision of written Informed Consent (TCLE) by the patient or their legal representative.
Key exclusion criteria (4 listed)
- Failure to sign the Informed Consent Form.
- Clinical manifestations lasting more than 30 days.
- Patients under 18 years of age.
- Patients who have undergone neurosurgery within 30 days prior to the onset of symptoms (applies to both prospective and control groups).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biofire FilmArray Meningitis/Encephalitis PanelThe Biofire FilmArray is a multiplex molecular diagnostic test that will be performed on 0.2 mL of cerebrospinal fluid (CSF) collected from patients via lumbar or suboccipital puncture. The system automatically performs DNA/RNA extraction, purification, multiplex PCR, and identification of 14 different pathogens (6 bacteria, 7 viruses, and 1 fungus). The complete process takes approximately one hour and provides qualitative results to guide therapeutic decisions such as antibiotic stewardship. | Diagnostic test | Biofire FilmArray group |
Primary outcome
Rate of BioFire® FilmArray® Meningitis/Encephalitis Panel Positivity
Time frame: At the time of BioFire® FilmArray® result availability, assessed up to 24 months
Proportion of positive BioFire® FilmArray® Meningitis/Encephalitis panel results among participants presenting with a clinical syndrome of meningitis and/or encephalitis and cerebrospinal fluid pleocytosis (≥ 5 cells/mm³).
9 secondary outcomes
Total hospital length of stay in days
Time frame: From hospital admission until hospital discharge or death, whichever occurs first, assessed up to 24 months.
Intensive care unit length of stay in days
Time frame: From intensive care unit admission until intensive care unit discharge or death, whichever occurs first, assessed up to 24 months.
Duration of antibiotic therapy in participants without confirmed bacterial infection
Time frame: From antibiotic initiation until discontinuation, hospital discharge, or death, whichever occurs first, assessed up to 24 months.
Duration of acyclovir therapy in participants without confirmed indication
Time frame: From acyclovir initiation until discontinuation, hospital discharge, or death, whichever occurs first, assessed up to 24 months.
Time to pathogen identification
Time frame: From cerebrospinal fluid collection until pathogen identification, when available, assessed up to 24 months.
In-hospital mortality
Time frame: From hospital admission until death or hospital discharge, whichever occurs first, assessed up to 24 months.
Need for hemodialysis
Time frame: From hospital admission until hospital discharge or death, whichever occurs first, assessed up to 24 months.
Direct medical costs
Time frame: From hospital admission until hospital discharge or death, whichever occurs first, assessed up to 24 months.
Use of neuroimaging
Time frame: From hospital admission until hospital discharge or death, whichever occurs first, assessed up to 24 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Background: PubMed 31720944Cailleaux M, Pilmis B, Mizrahi A, Lourtet-Hascoet J, Nguyen Van JC, Alix L, Couzigou C, Vidal B, Tattevin P, Le Monnier A. Impact of a multiplex PCR assay (FilmArray(R)) on the management of patients with suspected central nervous system infections. Eur J Clin Microbiol Infect Dis. 2020 Feb;39(2):293-297. doi: 10.1007/s10096-019-03724-7. Epub 2019 Nov 12.
- Background: PubMed 31111325Duff S, Hasbun R, Balada-Llasat JM, Zimmer L, Bozzette SA, Ginocchio CC. Economic analysis of rapid multiplex polymerase chain reaction testing for meningitis/encephalitis in adult patients. Infection. 2019 Dec;47(6):945-953. doi: 10.1007/s15010-019-01320-7. Epub 2019 May 20.
- Background: PubMed 29092659Soucek DK, Dumkow LE, VanLangen KM, Jameson AP. Cost Justification of the BioFire FilmArray Meningitis/Encephalitis Panel Versus Standard of Care for Diagnosing Meningitis in a Community Hospital. J Pharm Pract. 2019 Feb;32(1):36-40. doi: 10.1177/0897190017737697. Epub 2017 Nov 1.
- Background: PubMed 35198914Trujillo-Gomez J, Tsokani S, Arango-Ferreira C, Atehortua-Munoz S, Jimenez-Villegas MJ, Serrano-Tabares C, Veroniki AA, Florez ID. Biofire FilmArray Meningitis/Encephalitis panel for the aetiological diagnosis of central nervous system infections: A systematic review and diagnostic test accuracy meta-analysis. EClinicalMedicine. 2022 Feb 14;44:101275. doi: 10.1016/j.eclinm.2022.101275. eCollection 2022 Feb.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to ensure strict compliance with the Brazilian General Data Protection Law (LGPD) and to protect the privacy of participants, especially those from the retrospective cohort for whom a waiver of informed consent was granted due to the impossibility of contact.
Related trials for Meningitis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingObservational study
Fungal Infection Susceptibility
Cryptococcal Infection, Cryptococcal Pneumonia
RecruitingObservational study
Acute Treatment and Long-term Assessment of Adult Infectious Meningitis
Viral Meningitis, Bacterial Meningitis
RecruitingObservational study
Etiology, Pathogenesis, and Natural History of Idiopathic CD4+ Lymphocytopenia
Idiopathic CD4+ Lymphocytopenia, Cryptococcal Meningitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alessandro C Pasqualotto, PhD study chair
Federal University of Health Sciences of Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biofire FilmArray Meningitis/Encephalitis Panel in people with Meningitis and Encephalitic Infection, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alessandro C Pasqualotto, PhD (+55 51 999951614, pasqualotto@ufcspa.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of BioFire® FilmArray® Meningitis/Encephalitis Panel Positivity (time frame: At the time of BioFire® FilmArray® result availability, assessed up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07432113, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.