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Study of Lyme Neuroborreliosis

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

July 3, 2012
July 9, 2012
July 9, 2012
August 2012
May 2016   (Final data collection date for primary outcome measure)
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.
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Study of Lyme Neuroborreliosis
Study of Lyme Neuroborreliosis: Epidemiology, Manifestations, Diagnostics and Treatment
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Lyme Neuroborreliosis
  • Drug: Doxycycline
    Doxycycline: 100mg tablet two times per day, four weeks
  • Drug: Ceftriaxone
    2 g intravenous once a day, three weeks
  • Active Comparator: Ceftriaxone
    Treatment of intravenous ceftriaxone (2 g/day), three weeks
    Intervention: Drug: Ceftriaxone
  • Experimental: Doxycycline
    Treatment with oral doxycycline (200mg / day), four weeks
    Intervention: Drug: Doxycycline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
150
Same as current
May 2016
May 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Finland
 
 
NCT01635530
T1/2012
Not Provided
Not Provided
Not Provided
Jarmo Oksi, Turku University Hospital
Turku University Hospital
Not Provided
Not Provided
Turku University Hospital
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP