Suspected Early Lyme NeuroborreliosisNCT00942006
Doxycycline and Ceftriaxone in Suspected Early Lyme Neuroborreliosis
A study testing doxycycline and ceftriaxone in people with Suspected Early Lyme Neuroborreliosis, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
The investigators will compare doxycycline and ceftriaxone in treatment of patients with suspected early Lyme neuroborreliosis and normal CSF cell count. The study hypothesis is that the efficacy and adverse effects of both antibiotics are comparable. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Suspected Early Lyme Neuroborreliosis
- What is being tested?
- doxycycline and ceftriaxone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSlovenia
- Study dates
- Jul 2009to Nov 2011
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- age >15 years
- erythema migrans in 4 months period before neurologic symptoms
- normal CSF cell count
- absence of more defined clinical symptoms or signs for CNS involvement (radicular pain, meningeal signs, peripheral facial palsy).
Who cannot join
- pregnancy
- lactation
- allergy on doxycycline and ceftriaxone
- immune deficiency.
Trial locations and contacts
1 site in 1 country.
Slovenia1 site
UMC Ljubljana, Department of Infectious Diseases
Ljubljana, 1525
About this study
Official title: Doxycycline and Ceftriaxone in Patients With Suspected Early Lyme Neuroborreliosis and Normal CSF Cell Count.
The investigators will compare doxycycline and ceftriaxone in treatment of patients with suspected early Lyme neuroborreliosis and normal CSF cell count. The study hypothesis is that the efficacy and adverse effects of both antibiotics are comparable.
- Conditions
- Suspected Early Lyme Neuroborreliosis
- Being tested
- doxycycline, ceftriaxone
- Keywords
- Lyme neuroborreliosis, Lyme borreliosis, erythema migrans, doxycycline treatment, ceftriaxone treatment, outcome, subjective symptoms
- Medical subject headings
- Lyme Neuroborreliosis, Lyme Disease, Glossitis, Benign Migratory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
doxycyclineDrug
100 mg bid, 14 days
ceftriaxoneDrug
2g x 1 iv, 14 days
| Study group | Role | What they receive |
|---|---|---|
| LNB-doxycycline | Active comparator | Not described Receives: Drug: doxycycline |
| LNB-ceftriaxone | Active comparator | Not described Receives: Drug: ceftriaxone |
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 for suspected early Lyme neuroborreliosis with normal CSF cell count with doxycycline or ceftriaxone for 14 days.
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 posted20 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionNov 2010 (estimated)
- Study completionNov 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suspected Early Lyme NeuroborreliosisStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Investigators
- Franc Strle, MD PhD, Study chair, UMC Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00942006
- Sponsor's protocol ID
- LNB-doxy-ceftriaxone
- Status last verified
- Jul 2009
- First submitted
- 17 Jul 2009
- Last updated
- 20 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Doxycycline and Ceftriaxone in Patients With Suspected Early Lyme Neuroborreliosis and Normal CSF Cell Count.
- ClinicalTrials.gov ID
- NCT00942006
- Acronym / sponsor ID
- LNB-doxy-ceftriaxone
- Conditions
- Suspected Early Lyme Neuroborreliosis
- Keywords
- Lyme neuroborreliosis, Lyme borreliosis, erythema migrans, doxycycline treatment, ceftriaxone treatment, outcome, subjective symptoms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Nov 2010 (estimated)
- Study completion
- Nov 2011 (estimated)
- First posted
- 20 Jul 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 investigators will compare doxycycline and ceftriaxone in treatment of patients with suspected early Lyme neuroborreliosis and normal CSF cell count. The study hypothesis is that the efficacy and adverse effects of both antibiotics are comparable.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LNB-doxycycline | Active comparator | Drug: doxycycline |
| LNB-ceftriaxone | Active comparator | Drug: ceftriaxone |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- age >15 years
- erythema migrans in 4 months period before neurologic symptoms
- normal CSF cell count
- absence of more defined clinical symptoms or signs for CNS involvement (radicular pain, meningeal signs, peripheral facial palsy).
Key exclusion criteria (4 listed)
- pregnancy
- lactation
- allergy on doxycycline and ceftriaxone
- immune deficiency.
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 |
|---|---|---|
| doxycycline100 mg bid, 14 days | Drug | LNB-doxycycline |
| ceftriaxone2g x 1 iv, 14 days | Drug | LNB-ceftriaxone |
Primary outcome
Objective sequelae and post-treatment subjective symptoms in patients treated for suspected early Lyme neuroborreliosis with normal CSF cell count with doxycycline or ceftriaxone for 14 days.
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 20 Jul 2009.
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 PhD 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 doxycycline and ceftriaxone in people with Suspected Early Lyme Neuroborreliosis, 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 4 inclusion and 4 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 20 Jul 2009. 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 Katarina Ogrinc, MD PhD (+386 1 522 4217, katarina.ogrinc1@guest.arnes.si), 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 for suspected early Lyme neuroborreliosis with normal CSF cell count with doxycycline or ceftriaxone for 14 days. (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 20 Jul 2009.