Nervous System Lyme BorreliosisNCT00910533
Study on Early Lyme Neuroborreliosis
A study testing ceftriaxone in people with Nervous System Lyme Borreliosis, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
The purpose of this study is to determine clinical course and the sequelae of early Lyme neuroborreliosis after treatment with ceftriaxone. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nervous System Lyme Borreliosis
- What is being tested?
- ceftriaxone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Jan 2009to Dec 2020
- Phase
- Interventional
- 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 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- erythema migrans within 4 months before neurologic involvement and pleocytosis in patients >15 years old
Who cannot join
- pregnancy
- lactation
- history of adverse reaction to a beta-lactam antibiotic
Trial locations and contacts
1 site in 1 country.
Slovenia1 site, 1 recruiting
- Recruiting
UMC Ljubljana, Department of Infectious Diseases
Ljubljana, 1525
Dasa Stupica, MD, +386 1 522 2110, cerar.dasa@gmail.com
Franc Strle, MD, +386 1 5222610, franc.strle@kclj.si
About this study
Official title: Clinical and Microbiological Parameters in Patients With Early Lyme Neuroborreliosis
The purpose of this study is to determine clinical course and the sequelae of early Lyme neuroborreliosis after treatment with ceftriaxone.
- Conditions
- Nervous System Lyme Borreliosis
- Being tested
- ceftriaxone
- Keywords
- Lyme neuroborreliosis
- Medical subject headings
- Lyme Neuroborreliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ceftriaxoneDrug
ceftriaxone 2 g od i.v. for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Early Lyme neuroborreliosis patients | Active comparator | Not described Receives: Drug: ceftriaxone |
| control subjects | No intervention | Control subjects without a history of Lyme borreliosis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective sequelae and post-treatment subjective symptoms in patients treated with ceftriaxone for early Lyme neuroborreliosis
Measured: 1 year follow-up
Secondary outcomes (1)
Comparison of subjective symptoms between patients treated with ceftriaxone for early Lyme neuroborreliosis and control subjects without a history of Lyme borreliosis
Measured: 1 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2009 (estimated)
- Study start1 Jan 2009
- Primary completion31 Dec 2018 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nervous System Lyme BorreliosisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Franc Strle, University Medical Centre Ljubljana
- Investigators
- Franc Strle, MD, Study chair, UMC Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00910533
- Sponsor's protocol ID
- LNB-0509
- Status last verified
- May 2017
- First submitted
- 28 May 2009
- Last updated
- 16 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Microbiological Parameters in Patients With Early Lyme Neuroborreliosis
- ClinicalTrials.gov ID
- NCT00910533
- Acronym / sponsor ID
- LNB-0509
- Conditions
- Nervous System Lyme Borreliosis
- Keywords
- Lyme neuroborreliosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 1 Jan 2009
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 1 Jun 2009 (estimated)
- 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 purpose of this study is to determine clinical course and the sequelae of early Lyme neuroborreliosis after treatment with ceftriaxone.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Lyme neuroborreliosis patients | Active comparator | Drug: ceftriaxone |
| control subjects | No intervention | –Control subjects without a history of Lyme borreliosis. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- erythema migrans within 4 months before neurologic involvement and pleocytosis in patients >15 years old
Key exclusion criteria (3 listed)
- pregnancy
- lactation
- history of adverse reaction to a beta-lactam antibiotic
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 |
|---|---|---|
| ceftriaxoneceftriaxone 2 g od i.v. for 14 days | Drug | Early Lyme neuroborreliosis patients |
Primary outcome
Objective sequelae and post-treatment subjective symptoms in patients treated with ceftriaxone for early Lyme neuroborreliosis
Time frame: 1 year follow-up
1 secondary outcome
Comparison of subjective symptoms between patients treated with ceftriaxone for early Lyme neuroborreliosis and control subjects without a history of Lyme borreliosis
Time frame: 1 year follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2018.
Related trials for Nervous System Lyme Borreliosis
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Effectiveness of an Intervention Combining Adapted Physical Activity and Therapeutic Education in Patients With Chronic Symptoms Attributed to Lyme Borreliosis.
Lyme Borreliosis, Physical Activity
Not yet recruitingPhase 4
Doxycycline Boosted Therapy in Lyme Borreliosis: DoBo Study.
Lyme Borreliosis, Nervous System
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.
Franc Strle, MD study chair
UMC Ljubljana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ceftriaxone in people with Nervous System Lyme Borreliosis, run by University Medical Centre Ljubljana at 1 site in Slovenia.
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 1 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: status not confirmed, as of the sponsor's last update on 16 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dasa Stupica, MD (+38615222110, cerar.dasa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective sequelae and post-treatment subjective symptoms in patients treated with ceftriaxone for early Lyme neuroborreliosis (time frame: 1 year follow-up). 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 16 Oct 2018; AzTrials last refreshed its copy on 26 Oct 2026.