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Completed

NCT Number: NCT01635530

Study of Lyme Neuroborreliosis

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.

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Key information

Conditions

Lyme Neuroborreliosis Bacterial Infections Bacterial Infections and Mycoses Borrelia Infections Central Nervous System Bacterial Infections Central Nervous System Diseases Central Nervous System Infections Gram-Negative Bacterial Infections Infections Lyme Disease Nervous System Diseases Spirochaetales Infections Tick-Borne Diseases Vector Borne Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Helsinki University Hospital, Helsinki, Finland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

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

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

Treatment and study plan

Doxycycline

Drug

Doxycycline: 100mg tablet two times per day, four weeks

Ceftriaxone

Drug

2 g intravenous once a day, three weeks

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Turku University Hospital

Other Gov

Registry information

Official study title

Study of Lyme Neuroborreliosis: Epidemiology, Manifestations, Diagnostics and Treatment

Important dates

Study start
2012
Primary completion
2017
Study completion
2018
First posted
Jul 9, 2012
Registry last updated
May 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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