Impact on the Quality of Life and Persistent Symptoms of Patients Away From Diagnosed and Treated Neuroborreliosis

NCT ID: NCT05742139

Last Updated: 2023-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

159 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-27

Study Completion Date

2023-10-27

Brief Summary

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The link between Lyme neuroborreliosis (NBL) and persistent symptoms is debated in the medical world. Some report a frequency of post NBL symptoms similar to the general population, and others define a specific entity, the PTLDS (Post Treatment Lyme Disease Symptoms).

In France, few studies have evaluated the persistent symptoms and the impact on the quality of life of patients after treatment for NBL.

Detailed Description

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Conditions

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Neuroborreliosis, Lyme Quality of Life

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Patient group

Have been hospitalized or consulted for neuroborreliosis between 2010 and 2021; Have a diagnosis of probable neuroborreliosis (compatible clinical signs + lumbar puncture with positive intrathecal synthesis of immunoglobulins) or certain (compatible clinical signs + lumbar puncture with pleocytosis and positive intrathecal synthesis of immunoglobulins); Have received adequate treatment according to the recommendations (1st intention DOXYCYCLINE 100mgx2/day or 2nd intention CEFTRIAXONE IV 2g/day for 14 to 21

Non intervention

Intervention Type OTHER

Non intervention

Control group

Be part of the entourage of the cases; Do not have ATCD of Lyme borreliosis (especially erythema migrans); Not having been bitten by a tick in the last 5 years;

Non intervention

Intervention Type OTHER

Non intervention

Interventions

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Non intervention

Non intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Have been hospitalized or consulted for neuroborreliosis between 2010 and 2021;
* Have a diagnosis of probable neuroborreliosis (compatible clinical signs + lumbar puncture with positive intrathecal synthesis of immunoglobulins) or certain (compatible clinical signs + lumbar puncture with pleocytosis and positive intrathecal synthesis of immunoglobulins);
* Have received adequate treatment according to the recommendations (1st intention DOXYCYCLINE 100mgx2/day or 2nd intention CEFTRIAXONE IV 2g/day for 14 to 21

Exclusion Criteria

* Be part of the entourage of the cases;
* Do not have ATCD of Lyme borreliosis (especially erythema migrans);
* Not having been bitten by a tick in the last 5 years;
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hopital Nord Franche-Comte

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Besançon

Besançon, , France

Site Status

Hôpital Nord Franche-Comté

Trévenans, , France

Site Status

Countries

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France

Other Identifiers

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2022-A01583-40

Identifier Type: -

Identifier Source: org_study_id

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