Neuroborreliosis, LymeQoLymeNCT05742139
Impact on the Quality of Life and Persistent Symptoms of Patients Away From Diagnosed and Treated Neuroborreliosis
An observational study of Neuroborreliosis, Lyme and Quality of Life, run by Hopital Nord Franche-Comte at 2 sites in France.
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). Read more about this study
- Who is it for?
- Ages 18 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Neuroborreliosis, Lyme, Quality of Life
- What is being tested?
- Non intervention
- Type of treatment
- Injection or infusion
- How many people
- 159 participants
- Where
- 2 sitesFrance
- Study dates
- 27 Feb 2023to 27 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A online questionnaire is completed by the patient concerning socio-demographic date, patient history, quality of life scale, persistent neurological symptoms
Who may be able to join
- 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
Who cannot join
- 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;
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU Besançon
Besançon, 25000
Hôpital Nord Franche-Comté
Trévenans, 90400
About this study
Official title: Impact Sur la qualité de Vie et symptômes Persistants Des Patients à Distance d'Une neuroborréliose diagnostiquée et traitée
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.
- Conditions
- Neuroborreliosis, Lyme, Quality of Life
- Being tested
- Non intervention
- Medical subject headings
- Lyme Neuroborreliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non interventionOther
Non intervention
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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; Receives: Other: Non intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the quality of life of patients compared to a healthy control population using the SF-36 questionnaire and the Fatigue Scale Severity
Measured: At inclusion
Identification of symptoms recognized by the patient as persistent after neuroboreliosis from a list of referenced symptoms
Measured: At inclusion
Secondary outcomes (2)
Imputability according to the patient of his pain in relation to the initial infection
Measured: At inclusion
Comparison of symptoms and/or quality of life between patients with definite versus probable neuroborreliosis using the SF-36 questionnaire
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start27 Feb 2023
- Primary completion24 Aug 2023
- Study completion27 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroborreliosis, LymeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Nord Franche-Comte
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05742139
- Sponsor's protocol ID
- 2022-A01583-40
- Acronym
- QoLyme
- Status last verified
- Oct 2023
- First submitted
- 28 Dec 2022
- Last updated
- 14 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact Sur la qualité de Vie et symptômes Persistants Des Patients à Distance d'Une neuroborréliose diagnostiquée et traitée
- ClinicalTrials.gov ID
- NCT05742139
- Acronym / sponsor ID
- QoLyme / 2022-A01583-40
- Conditions
- Neuroborreliosis, Lyme, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Hopital Nord Franche-ComteUniversity, hospital or other
- Study start
- 27 Feb 2023 (actual)
- Primary completion
- 24 Aug 2023 (actual)
- Study completion
- 27 Oct 2023 (actual)
- First posted
- 23 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient group | – | Other: Non interventionHave 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 |
| Control group | – | Other: Non interventionBe 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; |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A online questionnaire is completed by the patient concerning socio-demographic date, patient history, quality of life scale, persistent neurological symptoms
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non interventionNon intervention | Other | Control group, Patient group |
Primary outcome
Assess the quality of life of patients compared to a healthy control population using the SF-36 questionnaire and the Fatigue Scale Severity
Time frame: At inclusion
Identification of symptoms recognized by the patient as persistent after neuroboreliosis from a list of referenced symptoms
Time frame: At inclusion
2 secondary outcomes
Imputability according to the patient of his pain in relation to the initial infection
Time frame: At inclusion
Comparison of symptoms and/or quality of life between patients with definite versus probable neuroborreliosis using the SF-36 questionnaire
Time frame: At inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuroborreliosis, Lyme and Quality of Life, run by Hopital Nord Franche-Comte at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the quality of life of patients compared to a healthy control population using the SF-36 questionnaire and the Fatigue Scale Severity (time frame: At inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2023.