Lyme NeuroborreliosisPhase 4NCT01635530
Study of Lyme Neuroborreliosis
A Phase 4 study testing Doxycycline and Ceftriaxone in people with Lyme Neuroborreliosis, run by Turku University Hospital at 2 sites in Finland.
Trial summary
The main purpose of this study is to determine whether four weeks treatment with oral doxycycline is as equally effective as three weeks treatment with intravenous ceftriaxone in patients with Lyme neuroborreliosis. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Lyme Neuroborreliosis
- What is being tested?
- Doxycycline and Ceftriaxone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 2 sitesFinland
- Study dates
- Aug 2012to 31 Dec 2018
- Phase
- Phase 4
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- pregnancy and breastfeeding
- women planning to get pregnant in two months
- age under 18
- handicapped persons
- prisoners
- use of any antibiotics two weeks before study treatments begins
- allergy for tetracyclines or cephalosporins
Trial locations and contacts
2 sites in 1 country.
Finland2 sites
Helsinki University Hospital
Helsinki, 00029
Turku University Hospital
Turku, 20521
About this study
Official title: Study of Lyme Neuroborreliosis: Epidemiology, Manifestations, Diagnostics and Treatment
The main purpose of this study is to determine whether four weeks treatment with oral doxycycline is as equally effective as three weeks treatment with intravenous ceftriaxone in patients with Lyme neuroborreliosis. The other purpose is to improve laboratory diagnostics of Lyme neuroborreliosis and further define the manifestations and epidemiology of the disease in Finland.
- Conditions
- Lyme Neuroborreliosis
- Being tested
- Doxycycline, Ceftriaxone
- Keywords
- doxycycline, ceftriaxone
- Medical subject headings
- Lyme Neuroborreliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxycyclineDrug
Doxycycline: 100mg tablet two times per day, four weeks
CeftriaxoneDrug
2 g intravenous once a day, three weeks
| Study group | Role | What they receive |
|---|---|---|
| Ceftriaxone | Active comparator | Treatment of intravenous ceftriaxone (2 g/day), three weeks Receives: Drug: Ceftriaxone |
| Doxycycline | Experimental | Treatment with oral doxycycline (200mg / day), four weeks Receives: Drug: Doxycycline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The improvement of the clinical condition during the study.
The clinical condition of participants will be evaluated with visual analogue scale (from 0 to 10, 0=best) by the participants. The VAS scores are collected before the treatment with antibiotics, and 4 months and 12 months after the treatment.
Measured: 12 months
The clinical condition evaluated by the participants after 12 months from the treatment
The clinical condition is evaluated with VAS by the participants.
Measured: 12 months
Secondary outcomes (4)
Central spinal fluid (CSF) pleocytosis
The decline in CSF leukocyte count between the patients in doxycycline and ceftriaxone groups
Measured: 3 weeks
CSF protein concentration
The decline in CSF protein concentration between the patients in doxycycline and ceftriaxone groups.
Measured: 3 weeks
CSF lactate level
The decline in CSF lactate level between the patients in doxycycline and ceftriaxone groups.
Measured: 3 weeks
CSF CXCL13 concentration
The decline in CSF CXCL13 concentration wetween the patients in doxycycline and ceftriaxone groups
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2012 (estimated)
- Study startAug 2012
- Primary completion31 Dec 2017
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lyme NeuroborreliosisStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jarmo Oksi, Turku University Hospital
- Investigators
- Jukka Hytönen, Principal investigator, University of TurkuElisa Kortela, Principal investigator, HYKSMari Kanerva, Principal investigator, HYKSLaura Airas, Principal investigator, TYKS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01635530
- Sponsor's protocol ID
- T1/2012
- Status last verified
- May 2019
- First submitted
- 3 Jul 2012
- Last updated
- 13 May 2019
- Results posted
- No
Publications
Kortela E, Kanerva MJ, Puustinen J, Hurme S, Airas L, Lauhio A, Hohenthal U, Jalava-Karvinen P, Nieminen T, Finnila T, Haggblom T, Pietikainen A, Koivisto M, Vilhonen J, Marttila-Vaara M, Hytonen J, Oksi J. Oral Doxycycline Compared to Intravenous Ceftriaxone in the Treatment of Lyme Neuroborreliosis: A Multicenter, Equivalence, Randomized, Open-label Trial. Clin Infect Dis. 2021 Apr 26;72(8):1323-1331. doi: 10.1093/cid/ciaa217.
PubMed 32133487
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Lyme Neuroborreliosis: Epidemiology, Manifestations, Diagnostics and Treatment
- ClinicalTrials.gov ID
- NCT01635530
- Acronym / sponsor ID
- T1/2012
- Conditions
- Lyme Neuroborreliosis
- Keywords
- doxycycline, ceftriaxone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- Aug 2012 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 9 Jul 2012 (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 main purpose of this study is to determine whether four weeks treatment with oral doxycycline is as equally effective as three weeks treatment with intravenous ceftriaxone in patients with Lyme neuroborreliosis. The other purpose is to improve laboratory diagnostics of Lyme neuroborreliosis and further define the manifestations and epidemiology of the disease in Finland.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ceftriaxone | Active comparator | Drug: CeftriaxoneTreatment of intravenous ceftriaxone (2 g/day), three weeks |
| Doxycycline | Experimental | Drug: DoxycyclineTreatment with oral doxycycline (200mg / day), four weeks |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- pregnancy and breastfeeding
- women planning to get pregnant in two months
- age under 18
- handicapped persons
- prisoners
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 |
|---|---|---|
| DoxycyclineDoxycycline: 100mg tablet two times per day, four weeks | Drug | Doxycycline |
| Ceftriaxone2 g intravenous once a day, three weeks | Drug | Ceftriaxone |
Primary outcome
The improvement of the clinical condition during the study.
Time frame: 12 months
The clinical condition of participants will be evaluated with visual analogue scale (from 0 to 10, 0=best) by the participants. The VAS scores are collected before the treatment with antibiotics, and 4 months and 12 months after the treatment.
The clinical condition evaluated by the participants after 12 months from the treatment
Time frame: 12 months
The clinical condition is evaluated with VAS by the participants.
4 secondary outcomes
Central spinal fluid (CSF) pleocytosis
Time frame: 3 weeks
CSF protein concentration
Time frame: 3 weeks
CSF lactate level
Time frame: 3 weeks
CSF CXCL13 concentration
Time frame: 3 weeks
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 13 May 2019.
- Derived from this study: PubMed 32133487Kortela E, Kanerva MJ, Puustinen J, Hurme S, Airas L, Lauhio A, Hohenthal U, Jalava-Karvinen P, Nieminen T, Finnila T, Haggblom T, Pietikainen A, Koivisto M, Vilhonen J, Marttila-Vaara M, Hytonen J, Oksi J. Oral Doxycycline Compared to Intravenous Ceftriaxone in the Treatment of Lyme Neuroborreliosis: A Multicenter, Equivalence, Randomized, Open-label Trial. Clin Infect Dis. 2021 Apr 26;72(8):1323-1331. doi: 10.1093/cid/ciaa217.
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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.
Jukka Hytönen principal investigator
University of Turku
Elisa Kortela principal investigator
HYKS
Mari Kanerva principal investigator
HYKS
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Doxycycline and Ceftriaxone in people with Lyme Neuroborreliosis, run by Turku University Hospital at 2 sites in Finland.
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 0 inclusion and 7 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 13 May 2019. 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 Finland. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The improvement of the clinical condition during the study. (time frame: 12 months). 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?
On the ClinicalTrials.gov record for NCT01635530, which also lists 1 linked publication.
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 13 May 2019.