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Novel Diagnostics for Early Lyme Disease

NCT03963635 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2019-08-13

No results posted yet for this study

Summary

There are more than 300,000 new cases of Lyme disease every year in the US. Lyme disease is a dangerous bacterial infection transmitted by tick bites and it becomes increasingly severe as the infection progresses. Definitive diagnosis is based on serum-based tests that have fundamental limitations: 1) current tests cannot detect early infections so patients do not receive antibiotic therapy until the infection has progressed, and 2) there is no way to measure if antibiotic therapy has been successful. MicroB-plex will address these two unmet clinical needs by introducing a novel, blood-based diagnostic method that will enable clinicians to diagnose infections earlier and to monitor the success of their interventions.

Conditions

  • Lyme Disease

Interventions

DIAGNOSTIC_TEST

MicroB-plex Lyme Immunoassay

Subject's blood and clinical data are collected to develop a diagnostic immunoassay

Sponsors & Collaborators

Principal Investigators

  • John L Daiss, PhD · MicroB-plex, Inc.

  • Frances E Lee, MD · MicroB-plex, Inc.

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-05-01
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03963635 on ClinicalTrials.gov