QIAstat-Dx® Meningitis/Encephalitis Panel Performance NCT05092438

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Trial Details — Status: Completed

Study for performance evaluation of the QIAstat-Dx® Meningitis/Encephalitis Panel in comparison with other chosen comparator methods.

This multicenter study aims to evaluate the performance of QIAstat-Dx Meningitis/Encephalitis (ME) Panel with another validated comparator method.

Recruitment information / eligibility
Status	Completed
Enrollment	600
Est. completion date	December 2, 2021
Est. primary completion date	December 2, 2021
Accepts healthy volunteers	No
Gender	All
Age group	N/A and older
Eligibility	Inclusion Criteria: - Residual specimens of CSF obtained by lumbar puncture from subjects with signs and symptoms of meningitis and/or encephalitis following completion of routine testing - Specimen that had not been centrifuged Adequate residual volume (=400 µl) Exclusion Criteria: - Specimens not fitting criteria outlined above - CSF obtained from an external ventricular drain or shunt source - Lack of clear subject identification or label on residual banked CSF specimen - Obvious physical damage of banked residual specimen - Repeat specimens from the same subject

Locations
Country	Name	City	State
United Kingdom	Qiagen	Manchester

Sponsors *(1)*
Lead Sponsor	Collaborator
QIAGEN Gaithersburg, Inc

United Kingdom,

Outcome
Type	Measure	Description	Time frame	Safety issue
Primary	sensitivity	positive percentage agreement	6 weeks
Primary	specificity	negative percentage agreement	6 weeks

See also
Status	Clinical Trial	Phase
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Active, not recruiting	`NCT05155553` - QIAstat-Dx® Meningitis/Encephalitis Panel Performance Evaluation Study
Not yet recruiting	`NCT05777499` - MUSic Therapy In Complex Specialist Neurorehabilitation	N/A
Completed	`NCT05370573` - Brazil ICU Encephalitis Surveillance
Not yet recruiting	`NCT03895281` - Clinical Evaluation of the FilmArray® Meningitis/Encephalitis (ME) Panel