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
|Condition or disease||Intervention/treatment||Phase|
|Lyme Neuroborreliosis||Drug: Doxycycline Drug: Ceftriaxone||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||210 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Active Comparator: Ceftriaxone
Treatment of intravenous ceftriaxone (2 g/day), three weeks
2 g intravenous once a day, three weeks
Treatment with oral doxycycline (200mg / day), four weeks
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
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
|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|