Study of Lyme Neuroborreliosis
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ClinicalTrials.gov Identifier: NCT01635530 |
Recruitment Status :
Completed
First Posted : July 9, 2012
Last Update Posted : May 13, 2019
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Condition or disease | Intervention/treatment | Phase |
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Lyme Neuroborreliosis | Drug: Doxycycline Drug: Ceftriaxone | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 210 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Study of Lyme Neuroborreliosis: Epidemiology, Manifestations, Diagnostics and Treatment |
Actual Study Start Date : | August 2012 |
Actual Primary Completion Date : | December 31, 2017 |
Actual Study Completion Date : | December 31, 2018 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Ceftriaxone
Treatment of intravenous ceftriaxone (2 g/day), three weeks
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Drug: Ceftriaxone
2 g intravenous once a day, three weeks |
Experimental: Doxycycline
Treatment with oral doxycycline (200mg / day), four weeks
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Drug: Doxycycline
Doxycycline: 100mg tablet two times per day, four weeks |
- 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.
- Central spinal fluid (CSF) pleocytosis [ Time Frame: 3 weeks ]The decline in CSF leukocyte count between the patients in doxycycline and ceftriaxone groups
- CSF protein concentration [ Time Frame: 3 weeks ]The decline in CSF protein concentration between the patients in doxycycline and ceftriaxone groups.
- CSF lactate level [ Time Frame: 3 weeks ]The decline in CSF lactate level between the patients in doxycycline and ceftriaxone groups.
- CSF CXCL13 concentration [ Time Frame: 3 weeks ]The decline in CSF CXCL13 concentration wetween the patients in doxycycline and ceftriaxone groups

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Ages Eligible for Study: | 18 Years to 100 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria for definite Lyme neuroborreliosis (Criteria 1-3 or 1 and 4 fulfilled):
- Neurological symptoms suggestive of LNB without other obvious reasons
- CSF pleocytosis (>4 leukocytes per mikrol)
- Intrathecal production of B. burgdorferi specific antibodies
- Detection of B. burgdorferi DNA in central spinal fluid
Inclusion Cirteria for possible LNB (criteria 1 and 2 or 3 fullfilled):
- Neurological symptoms suggestive of LNB wihtout other obvious reasons
- Production of B. burgdorferi spesific antibodies in serum
- Erythema migrans during the previous three months
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01635530
Finland | |
Helsinki University Hospital | |
Helsinki, Finland, 00029 | |
Turku University Hospital | |
Turku, Finland, 20521 |
Principal Investigator: | Jukka Hytönen | University of Turku | |
Principal Investigator: | Elisa Kortela | HYKS | |
Principal Investigator: | Mari Kanerva | HYKS | |
Principal Investigator: | Laura Airas | TYKS |
Responsible Party: | Jarmo Oksi, vs.prof, Turku University Hospital |
ClinicalTrials.gov Identifier: | NCT01635530 |
Other Study ID Numbers: |
T1/2012 |
First Posted: | July 9, 2012 Key Record Dates |
Last Update Posted: | May 13, 2019 |
Last Verified: | May 2019 |
doxycycline ceftriaxone |
Lyme Neuroborreliosis Lyme Disease Central Nervous System Bacterial Infections Bacterial Infections Borrelia Infections Gram-Negative Bacterial Infections Tick-Borne Diseases Spirochaetales Infections Central Nervous System Infections |
Central Nervous System Diseases Nervous System Diseases Doxycycline Ceftriaxone Anti-Bacterial Agents Anti-Infective Agents Antimalarials Antiprotozoal Agents Antiparasitic Agents |