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Clinical Trials/NCT03820999
NCT03820999
Unknown
Not Applicable

An Intervention in a Primary Healthcare Setting to Reduce Lyme Neuroborreliosis Treatment Delay

Odense University Hospital1 site in 1 country60 target enrollmentFebruary 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lyme Neuroborreliosis
Sponsor
Odense University Hospital
Enrollment
60
Locations
1
Primary Endpoint
Number of days from symptom debut to beginning of antibiotic treatment for Lyme neuroborreliosis
Last Updated
7 years ago

Overview

Brief Summary

This study evaluates the effect of written and oral information in a primary health care setting on 1) patients referred to specialised examination for Lyme neuroborreliosis, 2) delay from patient symptom debut to treatment for Lyme neuroborreliosis, and 3) number of Borrelia serology tests from primary health care.

Detailed Description

Lyme neuroborreliosis is among the most common neuroinfections in northern Europe. Residual symptoms after treatment are a frequent problem in Lyme neuroborreliosis, and an association between the delay from symptom debut to antibiotic treatment has been established. In a previous study on Funen Island, Denmark, the delay from day of symptom debut to treatment for Lyme neuroborreliosis patients was 24 days. This considerable treatment delay did not change in the 20 years study period. In the Danish health system, the general practitioners are the first medical professionals to see the majority of patients. They can refer patients to the hospital for further examination if indicated. Many general practitioners use Borrelia burgdorferi antibodies (igM/IgG) as a screening tool when they suspect Lyme disease or see patients with uncharacteristic symptoms. This is unfortunate, as the rash Erythema Migrans, the most common Borreliosis manifestation in Europe, is a clinical diagnosis. Only around 50% of patients have positive antibodies at time of Erythema Migrans diagnosis. Lyme neuroborreliosis is diagnosed based on symptoms and the results from the cerebrospinal fluid, and cannot be diagnosed based on serology, which only delays the time to diagnoses and treatment. The Danish guidelines on Lyme borreliosis therefore discourage general practitioners from using Borrelia serology. In the before mentioned study from Funen Island, several patients described multiple contacts to their general practitioners, where the symptoms of Lyme neuroborreliosis were not recognized. The cardinal symptom of radicular pain was associated with a longer delay than many of the less common symptoms of Lyme neuroborreliosis.

Registry
clinicaltrials.gov
Start Date
February 2019
End Date
April 1, 2021
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Fredrikke Christie Knudtzen

Speciality Registrar, Specialist in Infectious Diseases, Principal Investigator

Odense University Hospital

Eligibility Criteria

Inclusion Criteria

  • Primary care physicians with a postal code in an area of Funen Island with a Lyme neuroborreliosis incidens of \> 4.6/100.000
  • Patients with a postal address on Funen and a positive Borrelia intrathecal antibody test (diagnostic for lyme neuroborreliosis) performed at the Department of Clinical Microbiology, Odense University Hospital from January 1st 2017 - December 31st 2020
  • A Borrelia IgM/IgG serology ordered from Primary Health Care and performed at the Department of Clinical Microbiology, Odense University Hospital from January 1st 2017 - December 31st 2020

Exclusion Criteria

  • Primary care physicians with a postal code in an area of Funen Island with a Lyme neuroborreliosis incidens of \< 4.7/100.000

Outcomes

Primary Outcomes

Number of days from symptom debut to beginning of antibiotic treatment for Lyme neuroborreliosis

Time Frame: 0-90 days

Number of days from debut of neurological symptoms to beginning of antibiotic treatment for Lyme neuroborreliosis.

Secondary Outcomes

  • Number of yearly referred Lyme patients(Up to 4 years (1460 days).)
  • Number of Borrelia antibody tests in peripheral blood ordered by primary care physicians(Up to 4 years (1460 days).)

Study Sites (1)

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