Delve Detect CSF Test for Central Nervous System Infections
(IMPACT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new method to quickly diagnose infections in the brain and spinal cord, such as meningitis or encephalitis, using the Delve Detect CSF mNGS Test. The goal is to determine if earlier use of this test can help doctors make faster and better treatment decisions. The trial seeks individuals with symptoms like severe headaches, fever, or confusion who might have a central nervous system infection. Participants will have their spinal fluid tested with this new method, alongside the usual tests. As an unphased trial, it offers participants the opportunity to contribute to groundbreaking research that could improve diagnostic methods for future patients.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that the Delve Detect CSF mNGS Test is safe for diagnosing CNS infections?
Research has shown that the Delve Detect CSF mNGS test helps identify infections in the brain and spinal cord, such as meningitis and encephalitis. This test detects DNA from bacteria, viruses, fungi, and parasites in the fluid surrounding the brain and spine. It is already used in a certified lab, indicating it has been tested in real-world situations.
Studies have found that tests like Delve Detect can uncover infections that other methods might miss. No evidence suggests any harm from the test itself. As a diagnostic tool, it does not involve taking medicine or undergoing risky procedures.
The test aids doctors in understanding the cause of an infection, potentially leading to better treatment choices. This is crucial when traditional methods fail to provide answers. So far, there have been no reports of negative effects from using the test. The goal is to make diagnosis faster and more accurate.12345Why are researchers excited about this trial?
Researchers are excited about the Delve Detect CSF mNGS Test because it uses advanced metagenomic next-generation sequencing (mNGS) technology to precisely identify pathogens causing central nervous system infections. Unlike standard diagnostic methods, which often rely on culturing or targeted tests that can miss rare or unexpected pathogens, this test can rapidly analyze the entire genetic material in a cerebrospinal fluid (CSF) sample to detect a wide range of infectious agents. This comprehensive approach has the potential to improve diagnostic accuracy and speed, leading to quicker and more effective treatment decisions for patients with these serious infections.
What evidence suggests that the Delve Detect CSF mNGS test is effective for diagnosing central nervous system infections?
Research has shown that the Delve Detect CSF mNGS test is a promising tool for diagnosing infections in the brain and spinal cord. Studies have found that this test correctly identifies infections 63.1% of the time and almost never gives a false positive, with a specificity rate of 99.6%. This accuracy allows it to distinguish between infections and non-infections effectively. In this trial, participants in the experimental arm will undergo testing with the Delve Detect CSF mNGS test, which excels at identifying the germs causing diseases, particularly when traditional methods fail. This suggests that Delve Detect CSF effectively identifies the cause of infections like meningitis and encephalitis when standard tests fall short.26789
Who Is on the Research Team?
Steve Miller, M.D., Ph.D.
Principal Investigator
Delve Bio, Inc.
Are You a Good Fit for This Trial?
This trial is for people of any age who have symptoms suggesting a possible brain or spinal cord infection, such as headache, neck stiffness, fever, nausea/vomiting, confusion lasting over 24 hours without another cause, seizures not explained by other conditions, or abnormal brain/spinal imaging. Consent from the patient or guardian is required.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Enrollment and Initial Testing
Participants undergo informed consent and are enrolled in the study. CSF specimens are collected and sent for mNGS testing with Delve Detect CSF.
Diagnostic Workup
Delve Detect CSF test results are provided to treating physicians for clinical decision-making. Associated clinical information and health economic data are collected.
Follow-up
Participants are monitored for safety and effectiveness after diagnostic workup. Data collection continues for outcome measures.
What Are the Treatments Tested in This Trial?
Interventions
- Delve Detect CSF mNGS Test
Trial Overview
The study is testing whether using the Delve Detect CSF mNGS test earlier in diagnosing suspected central nervous system infections helps doctors find causes faster and make better decisions. All participants get this new test along with standard tests; results are compared to see if care improves.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Delve Bio, Inc.
Lead Sponsor
Citations
Investigation of the Delve Detect Cerebrospinal Fluid (CSF) ...
This cohort consists of patients admitted with suspected CNS infection, who will receive Delve Detect CSF mNGS testing from a prospectively collected CSF ...
Metagenomic Next-generation Sequencing in Patients With ...
We aimed to assess the accuracy, clinical efficacy, and limitations of metagenomic next-generation sequencing. (mNGS) for diagnosing infectious ...
Seven-year performance of a clinical metagenomic next- ...
The sensitivity, specificity and accuracy of mNGS testing for CNS infections were 63.1%, 99.6% and 92.9%, respectively. mNGS testing exhibited ...
4.
ctv.veeva.com
ctv.veeva.com/study/investigation-of-the-delve-detect-cerebrospinal-fluid-csf-metagenomic-next-generation-sequencingInvestigation of the Delve Detect Cerebrospinal Fluid (CSF ...
Delve Bio, Inc. is a developer of novel mNGS tests with the goal of aiding in the diagnosis of infectious diseases in several clinical ...
Broad, Agnostic Pathogen Detection through Metagenomic ...
Delve Bio has developed a robust mNGS platform for diagnosing central nervous system (CNS) infections.
Delve Detect
Get answers faster with Delve Detect. Simplify your meningitis/encephalitis workup. Identify infectious bacteria, viruses, fungi, and parasites using a single ...
Evaluating the Clinical Impact of Metagenomic Next ... - PMC
In a modeled scenario, utilizing an mNGS test, such as Delve Detect, in patients with DNA viral infections (n = 23) could lead to a reduction of up to 88 ...
8.
contagionlive.com
contagionlive.com/view/the-dawn-of-a-new-era-metagenomic-diagnostics-for-central-nervous-system-infectionsThe Dawn of a New Era: Metagenomic Diagnostics for ...
Delve Bio has moved mNGS sequencing from the lab into the clinic through its flagship testing service, Delve Detect , which delivers 22 percent ...
9.
finance.yahoo.com
finance.yahoo.com/sectors/healthcare/articles/delve-detect-enables-neurologists-treat-113300509.htmlDelve Detect Enables Neurologists to Treat CNS Infections ...
BOSTON, April 16, 2026--Delve Bio announces data showing Delve Detect enables neurologists to treat CNS infections when conventional testing ...
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