Lyme Neuroborreliosis Clinical Trial
Official title:
An Intervention in a Primary Healthcare Setting to Reduce Lyme Neuroborreliosis Treatment Delay
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.
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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
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N/A | |
| Completed |
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Phase 3 | |
| Completed |
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Phase 2 | |
| Completed |
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|
Phase 4 |