Study of Lyme Neuroborreliosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01635530
Recruitment Status : Unknown
Verified July 2012 by Jarmo Oksi, Turku University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : July 9, 2012
Last Update Posted : July 9, 2012
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)
Estimated Enrollment : 150 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
Study Start Date : August 2012
Estimated Primary Completion Date : May 2016
Estimated Study Completion Date : May 2016

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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier (NCT number): NCT01635530

Contact: Jarmo Oksi, vs. prof. +35823130786

Helsinki University Hospital Not yet recruiting
Helsinki, Finland, 00029
Contact: Mari Kanerva    +258941775930   
Principal Investigator: Mari Kanerva         
Turku University Hospital Not yet recruiting
Turku, Finland, 20521
Contact: Elisa Kortela    +35823130098   
Principal Investigator: Jarmo Oksi, vs. prof         
Sub-Investigator: Elisa Kortela         
Sub-Investigator: Jukka Hytönen         
Sponsors and Collaborators
Turku University Hospital

Responsible Party: Jarmo Oksi,, Turku University Hospital Identifier: NCT01635530     History of Changes
Other Study ID Numbers: T1/2012
First Posted: July 9, 2012    Key Record Dates
Last Update Posted: July 9, 2012
Last Verified: July 2012

Additional relevant MeSH terms:
Lyme Neuroborreliosis
Central Nervous System Bacterial Infections
Bacterial Infections
Lyme Disease
Borrelia Infections
Gram-Negative Bacterial Infections
Tick-Borne Diseases
Spirochaetales Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents