Predicting Meningitis/Encephalitis Pathogens with a Rapid BioFire Panel in Adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective study, conducted in two Brazilian hospitals, evaluates the pre-test probability of a positive BioFire FilmArray Meningitis/Encephalitis panel in adults with suspected CNS infection and CSF pleocytosis. It compares outcomes between patients tested with the panel and a retrospective control group who did not receive the panel in the prior four years. The study looks at clinical impact such as total hospital stay, ICU stay, antibiotic duration in non-bacterial cases, and time to de-escalation of acyclovir. Samples undergo standard CSF analyses and targeted tests as ordered by clinicians. The aim is to determine whether rapid molecular testing can inform treatment decisions and potentially improve resource use.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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.

Exclusion Criteria:

* 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).

Where it's running

• Irmandande Santa Casa de Porto Alegre
  Porto Alegre, Rio Grande do Sul, Brazil Recruiting

Study contacts

• Study coordinator: Alessandro C Pasqualotto, PhD
• Email: pasqualotto@ufcspa.edu.br
• Phone: +55 51 999951614

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.