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Trial record 2 of 5 for:    "Lyme Neuroborreliosis"

Study of Lyme Neuroborreliosis

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2012 by Turku University Hospital
Sponsor:
Information provided by (Responsible Party):
Jarmo Oksi, Turku University Hospital
ClinicalTrials.gov Identifier:
NCT01635530
First received: July 3, 2012
Last updated: July 6, 2012
Last verified: July 2012
  Purpose

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 Intervention Phase
Lyme Neuroborreliosis
Drug: Doxycycline
Drug: Ceftriaxone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of Lyme Neuroborreliosis: Epidemiology, Manifestations, Diagnostics and Treatment

Resource links provided by NLM:


Further study details as provided by Turku University Hospital:

Primary Outcome Measures:
  • The condition of study subjects [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 150
Study Start Date: August 2012
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01635530

Contacts
Contact: Jarmo Oksi, vs. prof. +35823130786 jarmo.oksi@utu.fi

Locations
Finland
Helsinki University Hospital Not yet recruiting
Helsinki, Finland, 00029
Contact: Mari Kanerva    +258941775930    mari.kanerva@hus.fi   
Principal Investigator: Mari Kanerva         
Turku University Hospital Not yet recruiting
Turku, Finland, 20521
Contact: Elisa Kortela    +35823130098    elilam@utu.fi   
Principal Investigator: Jarmo Oksi, vs. prof         
Sub-Investigator: Elisa Kortela         
Sub-Investigator: Jukka Hytönen         
Sponsors and Collaborators
Turku University Hospital
  More Information

No publications provided

Responsible Party: Jarmo Oksi, vs.prof, Turku University Hospital
ClinicalTrials.gov Identifier: NCT01635530     History of Changes
Other Study ID Numbers: T1/2012
Study First Received: July 3, 2012
Last Updated: July 6, 2012
Health Authority: Finland: Ethics Committee (TUKIJA, Valvira)
Finland: Finnish Medicines Agency

Additional relevant MeSH terms:
Lyme Neuroborreliosis
Bacterial Infections
Borrelia Infections
Central Nervous System Bacterial Infections
Central Nervous System Diseases
Central Nervous System Infections
Gram-Negative Bacterial Infections
Lyme Disease
Nervous System Diseases
Spirochaetales Infections
Tick-Borne Diseases
Ceftriaxone
Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiparasitic Agents
Antiprotozoal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014