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

Quality of Life Clinical Trial

— QoLyme  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05742139
• Other study ID #: 2022-A01583-40
• Status: Completed
• Start date: February 27, 2023
• Est. completion date: October 27, 2023

Study information

• Verified date: October 2023
• Source: Hopital Nord Franche-Comte
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: October 27, 2023
• Est. primary completion date: August 24, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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;

Related Conditions & MeSH terms

• Lyme Neuroborreliosis
• Quality of Life

Intervention

Other:
• Non intervention
Non intervention

Locations

Country	Name	City	State
France	CHU Besançon	Besançon
France	Hôpital Nord Franche-Comté	Trévenans

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Nord Franche-Comte

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Identification of symptoms recognized by the patient as persistent after neuroboreliosis from a list of referenced symptoms		At inclusion
Secondary	Imputability according to the patient of his pain in relation to the initial infection		At inclusion
Secondary	Comparison of symptoms and/or quality of life between patients with definite versus probable neuroborreliosis using the SF-36 questionnaire		At inclusion