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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
Sponsor:
Information provided by (Responsible Party):
Jarmo Oksi, Turku University Hospital

Brief 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. The other purpose is to improve laboratory diagnostics of Lyme neuroborreliosis and further define the manifestations and epidemiology of the disease in Finland.

Condition or disease Intervention/treatment Phase
Lyme Neuroborreliosis Drug: Doxycycline Drug: Ceftriaxone Phase 4

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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
Drug: Ceftriaxone
2 g intravenous once a day, three weeks

Experimental: Doxycycline
Treatment with oral doxycycline (200mg / day), four weeks
Drug: Doxycycline
Doxycycline: 100mg tablet two times per day, four weeks




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Central spinal fluid (CSF) pleocytosis [ Time Frame: 3 weeks ]
    The decline in CSF leukocyte count between the patients in doxycycline and ceftriaxone groups

  2. CSF protein concentration [ Time Frame: 3 weeks ]
    The decline in CSF protein concentration between the patients in doxycycline and ceftriaxone groups.

  3. CSF lactate level [ Time Frame: 3 weeks ]
    The decline in CSF lactate level between the patients in doxycycline and ceftriaxone groups.

  4. 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
Criteria

Inclusion Criteria for definite Lyme neuroborreliosis (Criteria 1-3 or 1 and 4 fulfilled):

  1. Neurological symptoms suggestive of LNB without other obvious reasons
  2. CSF pleocytosis (>4 leukocytes per mikrol)
  3. Intrathecal production of B. burgdorferi specific antibodies
  4. Detection of B. burgdorferi DNA in central spinal fluid

Inclusion Cirteria for possible LNB (criteria 1 and 2 or 3 fullfilled):

  1. Neurological symptoms suggestive of LNB wihtout other obvious reasons
  2. Production of B. burgdorferi spesific antibodies in serum
  3. 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

Information from the National Library of Medicine

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


Locations
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Finland
Helsinki University Hospital
Helsinki, Finland, 00029
Turku University Hospital
Turku, Finland, 20521
Sponsors and Collaborators
Turku University Hospital
Investigators
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Principal Investigator: Jukka Hytönen University of Turku
Principal Investigator: Elisa Kortela HYKS
Principal Investigator: Mari Kanerva HYKS
Principal Investigator: Laura Airas TYKS

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Responsible Party: Jarmo Oksi, vs.prof, Turku University Hospital
ClinicalTrials.gov Identifier: NCT01635530     History of Changes
Other Study ID Numbers: T1/2012
First Posted: July 9, 2012    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: May 2019
Keywords provided by Jarmo Oksi, Turku University Hospital:
doxycycline
ceftriaxone
Additional relevant MeSH terms:
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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