Vancomycin Exposure and Biomarker Tracking Using Real-time Monitoring of Interstitial Fluid

NCT07893223 | Not Yet Recruiting

• 1 other identifier: NTM-US-2026/013
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 5

Brief Summary

The goal of this observational study is to understand whether a wearable sensor (the Nutromics Sensor Device) can accurately measure drug and biomarker levels in the fluid just under the skin (interstitial fluid), instead of needing repeated blood draws, in adults admitted to hospital who are being treated with the antibiotic vancomycin or who are being monitored for signs of sepsis. The main questions it aims to answer are:

• How closely do interstitial fluid levels of vancomycin match levels measured in the blood at the same time?
• How closely do interstitial fluid levels of creatinine, C-reactive protein, and lactate (biomarkers linked to kidney function, inflammation, and infection severity) match levels measured in the blood?
• Can the device pick up on early biomarker trends that signal a patient may be developing acute kidney injury?
• How well does the device work overall, and does it perform consistently across different patients (by age, sex, ethnicity, body size, and health conditions) and over time?
• Is the device safe to wear? There is no comparison group receiving a different treatment. This study looks at how well the device's readings line up with standard blood tests, not about testing a new treatment. Participants will:
• Wear up to two small sensor patches on their upper arm during their hospital stay (up to 5 days), with each patch replaced every 48 hours
• Have blood samples taken as part of their routine care so results can be compared
• Have their medical records reviewed 30 days after finishing the study to check on their health outcomes

Conditions

Biomarkers; Acute Kidney Injury; Sepsis

Keywords

Vancomycin; Wearable Electronic Devices; Biomarkers; Interstitial Fluid; Extracellular Fluid

Outcome Measures

Primary Outcomes (4)

• Accuracy of Device-measured vancomycin ISF concentration vs. paired serum concentration

  Comparison of vancomycin concentration-time profiles and pharmacokinetic parameters (Cmax, Tmax, Cmin, AUC0-24) derived from interstitial fluid (Sensor Device) against paired serum vancomycin immunoassay results.

  Up to 5 Days

• Accuracy of Device-measured biomarker (creatinine, C-reactive protein, lactate) ISF concentration vs. paired serum concentration

  Determination of accuracy between Device-reported biomarker values and paired serum immunoassay results.

  Up to 5 days

• Relationship between ISF analyte concentrations and clinical outcomes

  Descriptive summary of association between ISF concentration profiles (vancomycin, creatinine, C-reactive protein, lactate) and 30-day clinical outcomes (discharge/readmission, morbidity, mortality, treatment-emergent adverse events).

  Through 30 days after study completion

• General performance characterisation of the Device

  Paired precision between simultaneously worn devices; device accuracy throughout wear duration; electrochemical sensor quality metrics.

  Up to 5 days

Secondary Outcomes (7)

• Device performance across patient subgroups

  Up to 5 days

• Device performance across patient subgroups

  Up to 5 days

• Device performance across patient subgroups

  Up to 5 days

• Device performance across patient subgroups

  Up to 5 days

• Stability and precision of the Device over time, compared to standard laboratory assays

  Up to 5 days

Study Arms (2)

Cohort 1

Hospitalised participants receiving vancomycin (Vancomycin monitoring)

Cohort 2

Hospitalised participants not receiving vancomycin (Biomarker Monitoring)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospitalized participants in the US.

You may qualify if:

• Capable of providing informed consent OR has a Medical Treatment Decision Maker who can provide informed consent per the informed consent form (ICF).
• Aged 18 years at time of enrolment.
• Prescribed vancomycin treatment for intravenous administration (Cohort 1 only); vancomycin treatment duration expected to be ≥48 hours from time of enrolment.
• Has a central or arterial catheter and/or a large-bore cannula, or is willing to have intermittent peripheral blood sampling.

You may not qualify if:

• Currently receiving an investigational drug or device that, in the Investigator's opinion, may affect participation in this trial.
• History of allergic reactions to metals, plastics and adhesives which, in the opinion of the Study Investigators, would increase the risk of allergic reaction associated with the Device.
• Dermatological (or other) condition, or fragile skin, which in the opinion of the Investigators would prevent application of the Nutromics Sensor Device.
• Severe oedema or local swelling at the intended application site that would likely impair ISF sampling.
• Immediate life-threatening instability where study procedures would interfere with urgent care (participant may be screened once stable).
• Pregnant, lactating, planning to become pregnant, breastfeed, or donate ova.

Sponsors & Collaborators

• Nutromics: lead

Study Sites (5)

Kaiser Permanente

Oakland, California, 94611, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Stanford

Stanford, California, 94305, United States

Location

Northwell Health

New Hyde Park, New York, 11040, United States

Location

Columbia University

New York, New York, 10032, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood; Serum

MeSH Terms

Conditions

Acute Kidney Injury; Sepsis

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: October 23, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: October 23, 2026

Record last verified: 2026-10

Locations

US (5)