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

Sponsor

Hopital Nord Franche-Comte (Other)

Overall Status

Recruiting

CT.gov ID

NCT05742139

Collaborator

(none)

180

Enrollment

Locations

1.9

Anticipated Duration (Months)

Patients Per Site

46.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Neuroborreliosis, Lyme Quality of Life	Other: Non intervention

Study Design

Study Type:

Observational

Anticipated Enrollment :

180 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Impact Sur la qualité de Vie et symptômes Persistants Des Patients à Distance d'Une neuroborréliose diagnostiquée et traitée

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Apr 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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	Other: Non intervention 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;	Other: Non intervention Non intervention

Arm

Intervention/Treatment

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

Other: Non intervention

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;

Other: Non intervention

Non intervention

Outcome Measures

Primary Outcome Measures

Assess the quality of life of patients compared to a healthy control population using the SF-36 questionnaire and the Fatigue Scale Severity [At inclusion]
Identification of symptoms recognized by the patient as persistent after neuroboreliosis from a list of referenced symptoms [At inclusion]

Secondary Outcome Measures

Imputability according to the patient of his pain in relation to the initial infection [At inclusion]
Comparison of symptoms and/or quality of life between patients with definite versus probable neuroborreliosis using the SF-36 questionnaire [At inclusion]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 95 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Besançon	Besançon		France	25000
2	Hôpital Nord Franche-Comté	Trévenans		France	90400

Sponsors and Collaborators

Hopital Nord Franche-Comte

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hopital Nord Franche-Comte

ClinicalTrials.gov Identifier:

NCT05742139

Other Study ID Numbers:

2022-A01583-40

First Posted:

Feb 23, 2023

Last Update Posted:

Feb 23, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Lyme Neuroborreliosis

Study Results

No Results Posted as of Feb 23, 2023