Investigation of the Delve Detect Cerebrospinal Fluid (CSF) Metagenomic Next-generation Sequencing (mNGS) Test When Used for the Initial Diagnostic Workup of Patients With Suspected Central Nervous System (CNS) Infection

Conditions

• Central Nervous System Infection

Eligibility Criteria

Sex

ALL

Age

N/A - N/A

Healthy Volunteers

Not accepted

Interventions

• Delve Detect CSF mNGS Test — DIAGNOSTIC_TEST
  This cohort consists of patients admitted with suspected CNS infection, who will receive Delve Detect CSF mNGS testing from a prospectively collected CSF specimen. The results of the Delve Detect CSF mNGS Test will be returned to the patient's treatment team for clinical decision making.
• Real-World Data — OTHER
  For the analysis of secondary and exploratory outcomes, a control population of patients who were diagnosed and treated without the use of CSF mNGS testing will be constructed using real-world data (RWD). The control population will have approximately equal proportions of demographics, disease severity, and subpopulation categories as the prospective enrollment population. RWD will be used to examine the potential effect that testing with Delve Detect CSF had on the selected outcomes with the prospectively enrolled participants by collecting data for patients who were diagnosed and treated without the use of CSF mNGS testing. These participants will be enrolled in the non-mNGS control population and have de-identified RWD collected through a waiver of informed consent as appropriate for comparison to the prospective enrollment population.

Study Details

Delve Bio, Inc. is a developer of novel mNGS tests with the goal of aiding in the diagnosis of infectious diseases in several clinical indications that may not have alternative traditional diagnostic methods routinely available. A proof of concept for the clinical utility of this mNGS testing methodology has been described in several seminal publications.1,2,3,4 Delve Bio is currently offering one of these assays as a laboratory-developed test (LDT) performed in a CLIA-certified, CAP-accredited laboratory. The test is called Delve Detect CSF. Delve Detect CSF is an mNGS in vitro diagnostic test intended for the simultaneous detection and differentiation of nucleic acids from multiple bacteria, viruses, fungi, and parasites in CSF from individuals suspected of meningitis or encephalitis. Delve Detect CSF identifies microbial nucleic acid in an unbiased and pathogen-agnostic manner. Historically, due to its cost and turnaround times, which can be on the order of 14 days, CSF mNGS testing is typically employed as a "test of last resort" for patients with suspected infectious meningitis and encephalitis, and is often used when traditional diagnostic methods cannot identify the cause of infection. In the IMPACT Study, we seek to investigate the diagnostic and clinical utility of mNGS testing if it is employed earlier in the diagnostic workup of patients with suspected CNS infection and unknown etiology in conjunction with a more rapid turnaround time for test results on the order of two business days from sample receipt by the laboratory. Participants who meet the inclusion/exclusion criteria and undergo informed consent (and assent as applicable) will be enrolled in the study, assigned to the appropriate subpopulation category, and obtain CSF testing with Delve Detect CSF in addition to other SOC testing. In addition to the Delve Detect CSF test results, associated clinical information and health economic data for the participants will be obtained through chart abstraction. Clinical information will be de-identified wherever possible, and any PHI being collected will not be individually reported as part of the intended analysis. The site investigator or their designee at each site will complete a survey to provide a consensus view of the treatment team regarding how the availability of Delve Detect CSF test results in early diagnostic workup affected clinical decision-making. Analyses of the test results from Delve Detect CSF and other SOC diagnostic methods, in addition to the clinical information, will not be used to identify any participant. Information generated through the study will be recorded in such a manner that the identity of the human participants cannot readily be ascertained directly or through identifiers linked to the participants, and the participants will not be contacted. The results from this study could be used to support publications in scientific white papers, manuscripts, posters, and/or presentations.

Key Dates

Start date

May 1, 2026

Status verified

Jun 2026

Primary completion

Jun 1, 2027

Completion

Sep 1, 2027

Study Design

Enrollment

400 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Arms

• Experimental: Prospectively Collected Patients tested with Delve Detect mNGS
  Participants will be identified as candidates for the prospective enrollment population by clinicians who are treating the patients and/or laboratory investigators performing clinical testing on initial samples obtained from the patients through inpatient or ICU admission. Patients may be identified and enrolled in the study prior to or after CSF collection has been performed. Following informed consent and assent procedures, as applicable, participants will be enrolled in the study. Following enrollment and informed consent/assent, 500 - 1000 µL of CSF specimen collected as part of the first LP for SOC diagnostic workup will be sent for mNGS testing with the Delve Detect CSF test. Delve Detect CSF test results will be provided to treating physicians for clinical decision-making.
• Active Comparator: Real-World Data Control Cohort
  RWD will be used to construct a control dataset for patients who were diagnosed and treated without the use of CSF mNGS. An attempt will be made to match the calendar time period/duration, and proportions of sex, age, disease, etiology (infectious/non-infectious), and subpopulation categories as the prospective enrollment population. The intent of the control population is to enable secondary and exploratory outcome comparisons by collecting data for patients who were diagnosed and treated without the use of CSF mNGS testing.

Primary Outcome Measure

Overall Diagnostic Yield [ Time Frame: From Enrollment to 90 Days Post-Discharge for Each Patient ]

Central Contacts

• Steve Miller, M.D., Ph.D.
  844-221-7423
  [email protected]
• Timothy Blicharz, Ph.D.
  [email protected]

Locations (3)

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