Central Nervous System InfectionIMPACTNCT07435649
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
A study testing Delve Detect CSF mNGS Test and Real-World Data in people with Central Nervous System Infection, run by Delve Bio, Inc. at 6 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Central Nervous System Infection
- What is being tested?
- Delve Detect CSF mNGS Test and Real-World Data
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 6 sitesUnited States
- Study dates
- 1 May 2026to 1 Sep 2027
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Must be willing and able to provide informed consent or have a legally authorized representative (LAR) willing and able to provide informed consent for participation in the study:
- Adults, 18 years of age or older, must provide informed consent, or if unable to provide consent, must have voluntary informed consent provided by a LAR b. Children < 18 years of age must have informed consent provided by a parent, guardian, or LAR, and: i. If 7 years of age or older, must provide voluntary assent for participation, unless unable to do so If less than 7 years of age, assent should also be obtained, if feasible.
- Individuals presenting with, or admitted or transferred with, suspected CNS infection with at least 2 of the following clinical signs and symptoms:
- Headache
- Photophobia
- Neck stiffness
Show all 39Show fewer
- Nausea/vomiting
- Documented fever ≥ 38°C (100.4°F)
- Altered mental status (defined as decreased or altered level of consciousness, lethargy, or personality change) lasting ≥ 24 h with no alternative cause identified
- Generalized or partial seizures not fully attributable to a preexisting seizure disorder, identified toxic-metabolic derangement, or alcohol withdrawal
- Abnormality of brain parenchyma on neuroimaging suggestive of CNS infection that is either new from prior studies or appears acute in onset
- Abnormal spinal cord imaging suggestive of myelitis
- Note: The clinical signs and symptoms list above applies to non-infant participants (≥ 1 year old). Infants (< 1 year old) who are suspected of CNS infection may be enrolled if they present with fever ≥ 38°C (100.4°F) OR hypothermia < 36.5°C (97.7°F) AND at least 1 of the following clinical signs and symptoms:
- Bulging fontanel (soft spot)
- Lethargy or irritability
- Refusing to feed or poor feeding
- Apnea
- Hypotonia or Hypertonia
- Exclusionary participant characteristics:
- Unable to obtain consent (or assent, as applicable) from potential participant or legally authorized representative (LAR)
- Established diagnosis of non-infectious etiology responsible for symptoms of meningitis/encephalitis/myelitis, with confirmation prior to lumbar puncture (LP) being performed
- Established diagnosis of infectious etiology responsible for symptoms with microbiologic confirmation prior to LP being performed
- Established diagnosis of infectious etiology responsible for symptoms prior to CSF sample being sent for testing with Delve Detect CSF
- Note: participants already consented and enrolled in the study who obtain a positive test result from SOC testing prior to the CSF sample being sent for testing with Delve Detect CSF will be withdrawn from the study and excluded from analysis.
- Low clinical suspicion for infection with one of the following known diagnoses related to the patient admission prior to LP being performed. Remote history of these diagnoses does not exclude the patient from eligibility:
- Trauma
- Ischemic or hemorrhagic stroke unless suspected to be due to infectious etiology
- Postictal or metabolic encephalopathy
- Malignancy without present infection symptoms
- Demyelinating disease
- Exclusionary CSF sample characteristics:
- No evidence of CSF pleocytosis (defined as CSF white blood cell count (WBC) ≥ 5 cells per μL) in the first LP collected.
- Note: Exclusion criterion 4 applies to participants who are immunocompetent or otherwise not known to have a current immunodeficiency or immunocompromised status. Individuals with a current immunodeficiency or immunocompromised status (as defined in Section 9.3) may be enrolled with or without the presence of CSF pleocytosis and continue to final analysis.
- Insufficient residual CSF volume available for Delve Detect testing (< 500 μL)
- The residual CSF sample available for testing with Delve Detect CSF was not the first diagnostic LP for the participant's current admission
- Residual CSF was stored at room temperature for ≥ 6 hours
- Residual CSF was stored refrigerated (2-8 °C) for ≥ 7 days
- Residual CSF was stored frozen (≤ -70 °C) for ≥ 90 days
- Residual CSF experienced more than a cumulative two freeze-thaw cycles
Who cannot join
None listed.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Timothy Blicharz, Ph.D. contact
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Emory University Hospital
Atlanta, Georgia, 30322
Anna Piantadosi, MD, PhD, 404-712-9005, anne.piantadosi@emory.edu
Anne Piantadosi, MD, PhD
- Recruiting
University of Maryland, Baltimore
Baltimore, Maryland, 21201
Jonathan Baghdadi, MD, PhD, 410-706-0066, jbaghdadi@som.umaryland.edu
Jonathan Baghdadi, MD, PhD
- Not yet recruiting
Boston Medical Center
Boston, Massachusetts, 02118
Pria Anand, MD, 617-638-8456, pria2@bu.edu
Pria Anand, MD
- Recruiting
Lahey Hospital & Medical Center
Burlington, Massachusetts, 01805
Joseph Burns, MD, 781-744-8630, joseph.d.burns@lahey.org
Joseph Burns, MD
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Buddy Creech, MD, MPH, 615-343-0332, buddy.creech@vumc.edu
Buddy Creech, MD, MPH
- Recruiting
University of California at San Francisco at Zuckerberg San Francisco General
San Francisco, California, 94110
Colette Match, PhD, MPH, 628-206-3595, colette.match@ucsf.edu
Colette Match, PhD, MPH
About this study
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.
- Conditions
- Central Nervous System Infection
- Being tested
- Delve Detect CSF mNGS Test, Real-World Data
- Keywords
- Delve Bio, IMPACT Study, mNGS, Central Nervous System (CNS) Infection
- Medical subject headings
- Central Nervous System Infections, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delve Detect CSF mNGS TestDiagnostic 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 DataOther
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 group | Role | What they receive |
|---|---|---|
| Prospectively Collected Patients tested with Delve Detect mNGS | Experimental | 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. Receives: Diagnostic Test: Delve Detect CSF mNGS Test |
| Real-World Data Control Cohort | Active comparator | 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. Receives: Other: Real-World Data |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Diagnostic Yield
The primary endpoint of the study is to investigate the utility of Delve Detect CSF with respect to the overall diagnostic yield compared to SOC diagnostic testing.
Measured: From Enrollment to 90 Days Post-Discharge for Each Patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 May 2026
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Sep 2027 (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 Central Nervous System InfectionStudies 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
- Single group
- Model description
- Up to 400 participants will be enrolled in the prospective cohort. For the analysis of secondary and exploratory outcomes, a synthetic control population of patients who were treated without the use of CSF mNGS will be constructed using real-world data (RWD) to examine the potential effect that testing with Delve Detect CSF has on the selected outcomes with the prospectively enrolled participants.
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Delve Bio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steve Miller, M.D., Ph.D., Principal investigator, Delve Bio, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07435649
- Sponsor's protocol ID
- CLN-GEN-PLN-004
- Acronym
- IMPACT
- Status last verified
- Oct 2026
- First submitted
- 18 Feb 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Analyses of the test results from the Delve Detect CSF mNGS Test and any other SOC diagnostic methods, in addition to the clinical information, will not be used to identify any participant. Following informed consent, participants will be de-identified through the assignment of a unique number according to a standard procedure that will be provided to each investigational site. The participant ID will be used in conjunction with the unique Delve Detect CSF ID number included on each CSF specimen transfer tube used for mNGS testing for each participant. The results from this study could be used to support publications in scientific white papers, manuscripts, posters, and/or presentations.
Publications
Benoit P, Brazer N, de Lorenzi-Tognon M, Kelly E, Servellita V, Oseguera M, Nguyen J, Tang J, Omura C, Streithorst J, Hillberg M, Ingebrigtsen D, Zorn K, Wilson MR, Blicharz T, Wong AP, O'Donovan B, Murray B, Miller S, Chiu CY. Seven-year performance of a clinical metagenomic next-generation sequencing test for diagnosis of central nervous system infections. Nat Med. 2024 Dec;30(12):3522-3533. doi: 10.1038/s41591-024-03275-1. Epub 2024 Nov 12.
PubMed 39533109Wilson MR, Sample HA, Zorn KC, Arevalo S, Yu G, Neuhaus J, Federman S, Stryke D, Briggs B, Langelier C, Berger A, Douglas V, Josephson SA, Chow FC, Fulton BD, DeRisi JL, Gelfand JM, Naccache SN, Bender J, Dien Bard J, Murkey J, Carlson M, Vespa PM, Vijayan T, Allyn PR, Campeau S, Humphries RM, Klausner JD, Ganzon CD, Memar F, Ocampo NA, Zimmermann LL, Cohen SH, Polage CR, DeBiasi RL, Haller B, Dallas R, Maron G, Hayden R, Messacar K, Dominguez SR, Miller S, Chiu CY. Clinical Metagenomic Sequencing for Diagnosis of Meningitis and Encephalitis. N Engl J Med. 2019 Jun 13;380(24):2327-2340. doi: 10.1056/NEJMoa1803396.
PubMed 31189036Miller S, Naccache SN, Samayoa E, Messacar K, Arevalo S, Federman S, Stryke D, Pham E, Fung B, Bolosky WJ, Ingebrigtsen D, Lorizio W, Paff SM, Leake JA, Pesano R, DeBiasi R, Dominguez S, Chiu CY. Laboratory validation of a clinical metagenomic sequencing assay for pathogen detection in cerebrospinal fluid. Genome Res. 2019 May;29(5):831-842. doi: 10.1101/gr.238170.118. Epub 2019 Apr 16.
PubMed 30992304Wilson MR, Naccache SN, Samayoa E, Biagtan M, Bashir H, Yu G, Salamat SM, Somasekar S, Federman S, Miller S, Sokolic R, Garabedian E, Candotti F, Buckley RH, Reed KD, Meyer TL, Seroogy CM, Galloway R, Henderson SL, Gern JE, DeRisi JL, Chiu CY. Actionable diagnosis of neuroleptospirosis by next-generation sequencing. N Engl J Med. 2014 Jun 19;370(25):2408-17. doi: 10.1056/NEJMoa1401268. Epub 2014 Jun 4.
PubMed 24896819
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07435649
- Acronym / sponsor ID
- IMPACT / CLN-GEN-PLN-004
- Conditions
- Central Nervous System Infection
- Keywords
- Delve Bio, IMPACT Study, mNGS, Central Nervous System (CNS) Infection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Delve Bio, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 May 2026 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 27 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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Up to 400 participants will be enrolled in the prospective cohort. For the analysis of secondary and exploratory outcomes, a synthetic control population of patients who were treated without the use of CSF mNGS will be constructed using real-world data (RWD) to examine the potential effect that testing with Delve Detect CSF has on the selected outcomes with the prospectively enrolled participants.
| Arm | Type | Receives |
|---|---|---|
| Prospectively Collected Patients tested with Delve Detect mNGS | Experimental | Diagnostic Test: Delve Detect CSF mNGS TestParticipants 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. |
| Real-World Data Control Cohort | Active comparator | Other: Real-World DataRWD 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (39 listed)
- Must be willing and able to provide informed consent or have a legally authorized representative (LAR) willing and able to provide informed consent for participation in the study:
- Individuals presenting with, or admitted or transferred with, suspected CNS infection with at least 2 of the following clinical signs and symptoms:
- Note: The clinical signs and symptoms list above applies to non-infant participants (≥ 1 year old). Infants (< 1 year old) who are suspected of CNS infection may be enrolled if they present with fever ≥ 38°C (100.4°F) OR hypothermia < 36.5°C (97.7°F) AND at least 1 of the following clinical signs and symptoms:
- Bulging fontanel (soft spot)
- Lethargy or irritability
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Delve Detect CSF mNGS TestThis 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. | Diagnostic test | Prospectively Collected Patients tested with Delve Detect mNGS |
| Real-World DataFor 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. | Other | Real-World Data Control Cohort |
Primary outcome
Overall Diagnostic Yield
Time frame: From Enrollment to 90 Days Post-Discharge for Each Patient
The primary endpoint of the study is to investigate the utility of Delve Detect CSF with respect to the overall diagnostic yield compared to SOC diagnostic testing.
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 29 Oct 2026.
- Background: PubMed 39533109Benoit P, Brazer N, de Lorenzi-Tognon M, Kelly E, Servellita V, Oseguera M, Nguyen J, Tang J, Omura C, Streithorst J, Hillberg M, Ingebrigtsen D, Zorn K, Wilson MR, Blicharz T, Wong AP, O'Donovan B, Murray B, Miller S, Chiu CY. Seven-year performance of a clinical metagenomic next-generation sequencing test for diagnosis of central nervous system infections. Nat Med. 2024 Dec;30(12):3522-3533. doi: 10.1038/s41591-024-03275-1. Epub 2024 Nov 12.
- Background: PubMed 31189036Wilson MR, Sample HA, Zorn KC, Arevalo S, Yu G, Neuhaus J, Federman S, Stryke D, Briggs B, Langelier C, Berger A, Douglas V, Josephson SA, Chow FC, Fulton BD, DeRisi JL, Gelfand JM, Naccache SN, Bender J, Dien Bard J, Murkey J, Carlson M, Vespa PM, Vijayan T, Allyn PR, Campeau S, Humphries RM, Klausner JD, Ganzon CD, Memar F, Ocampo NA, Zimmermann LL, Cohen SH, Polage CR, DeBiasi RL, Haller B, Dallas R, Maron G, Hayden R, Messacar K, Dominguez SR, Miller S, Chiu CY. Clinical Metagenomic Sequencing for Diagnosis of Meningitis and Encephalitis. N Engl J Med. 2019 Jun 13;380(24):2327-2340. doi: 10.1056/NEJMoa1803396.
- Background: PubMed 30992304Miller S, Naccache SN, Samayoa E, Messacar K, Arevalo S, Federman S, Stryke D, Pham E, Fung B, Bolosky WJ, Ingebrigtsen D, Lorizio W, Paff SM, Leake JA, Pesano R, DeBiasi R, Dominguez S, Chiu CY. Laboratory validation of a clinical metagenomic sequencing assay for pathogen detection in cerebrospinal fluid. Genome Res. 2019 May;29(5):831-842. doi: 10.1101/gr.238170.118. Epub 2019 Apr 16.
- Background: PubMed 24896819Wilson MR, Naccache SN, Samayoa E, Biagtan M, Bashir H, Yu G, Salamat SM, Somasekar S, Federman S, Miller S, Sokolic R, Garabedian E, Candotti F, Buckley RH, Reed KD, Meyer TL, Seroogy CM, Galloway R, Henderson SL, Gern JE, DeRisi JL, Chiu CY. Actionable diagnosis of neuroleptospirosis by next-generation sequencing. N Engl J Med. 2014 Jun 19;370(25):2408-17. doi: 10.1056/NEJMoa1401268. Epub 2014 Jun 4.
- Individual participant dataSharing planned: Undecided. Analyses of the test results from the Delve Detect CSF mNGS Test and any other SOC diagnostic methods, in addition to the clinical information, will not be used to identify any participant. Following informed consent, participants will be de-identified through the assignment of a unique number according to a standard procedure that will be provided to each investigational site. The participant ID will be used in conjunction with the unique Delve Detect CSF ID number included on each CSF specimen transfer tube used for mNGS testing for each participant. The results from this study could be used to support publications in scientific white papers, manuscripts, posters, and/or presentations.
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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.
Timothy Blicharz, Ph.D. contact
Steve Miller, M.D., Ph.D. principal investigator
Delve Bio, Inc.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Delve Detect CSF mNGS Test and Real-World Data in people with Central Nervous System Infection, run by Delve Bio, Inc. at 6 sites in United States.
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 39 inclusion and 0 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 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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 Steve Miller, M.D., Ph.D. (844-221-7423, steve.miller@delve.bio), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Diagnostic Yield (time frame: From Enrollment to 90 Days Post-Discharge for Each Patient). 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 NCT07435649, 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 29 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.