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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 : January 15, 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 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

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 condition of study subjects [ Time Frame: 12 months ]
    The condition of study subjects will be measured with scale (including numbers 0-10) before the treatment with antibiotic, 4 months and 12 months after the treatment.



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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:

  • patients with typical clinical manifestations of Lyme neuroborreliosis and intrathecal antibody production against Borrelia burgdorferi
  • patients with typical clinical manifestations of Lyme neuroborreliosis and erythema migrans within three months
  • patients with some clinical manifestations of Lyme neuroborreliosis and presence of antibodies against Borrelia burgdorferi bacteria in blood.

Exclusion Criteria:

  • pregnancy
  • lactation
  • use of any antibiotics two weeks before study treatments begins
  • an allergy to ceftriaxone or doxycycline

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
Finland
Helsinki University Hospital
Helsinki, Finland, 00029
Turku University Hospital
Turku, Finland, 20521
Sponsors and Collaborators
Turku University Hospital
Investigators
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     History of Changes
Other Study ID Numbers: T1/2012
First Posted: July 9, 2012    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019

Additional relevant MeSH terms:
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