NCT01635530

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2012

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 3, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 9, 2012

Completed
23 days until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

May 13, 2019

Status Verified

May 1, 2019

Enrollment Period

5.4 years

First QC Date

July 3, 2012

Last Update Submit

May 9, 2019

Conditions

Lyme Neuroborreliosis

Keywords

doxycyclineceftriaxone

Outcome Measures

Primary Outcomes (2)

  • The improvement of the clinical condition during the study.

    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.

    12 months

  • The clinical condition evaluated by the participants after 12 months from the treatment

    The clinical condition is evaluated with VAS by the participants.

    12 months

Secondary Outcomes (4)

  • Central spinal fluid (CSF) pleocytosis

    3 weeks

  • CSF protein concentration

    3 weeks

  • CSF lactate level

    3 weeks

  • CSF CXCL13 concentration

    3 weeks

Study Arms (2)

Ceftriaxone

ACTIVE COMPARATOR

Treatment of intravenous ceftriaxone (2 g/day), three weeks

Drug: Ceftriaxone

Doxycycline

EXPERIMENTAL

Treatment with oral doxycycline (200mg / day), four weeks

Drug: Doxycycline

Interventions

DoxycyclineDRUG

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

Doxycycline
CeftriaxoneDRUG

2 g intravenous once a day, three weeks

Ceftriaxone

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Neurological symptoms suggestive of LNB wihtout other obvious reasons
  • Production of B. burgdorferi spesific antibodies in serum
  • Erythema migrans during the previous three months

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Helsinki University Hospital

Helsinki, 00029, Finland

Location

Turku University Hospital

Turku, 20521, Finland

Location

Related Publications (1)

  • Kortela E, Kanerva MJ, Puustinen J, Hurme S, Airas L, Lauhio A, Hohenthal U, Jalava-Karvinen P, Nieminen T, Finnila T, Haggblom T, Pietikainen A, Koivisto M, Vilhonen J, Marttila-Vaara M, Hytonen J, Oksi J. Oral Doxycycline Compared to Intravenous Ceftriaxone in the Treatment of Lyme Neuroborreliosis: A Multicenter, Equivalence, Randomized, Open-label Trial. Clin Infect Dis. 2021 Apr 26;72(8):1323-1331. doi: 10.1093/cid/ciaa217.

    PMID: 32133487DERIVED

MeSH Terms

Conditions

Lyme Neuroborreliosis

Interventions

DoxycyclineCeftriaxone

Condition Hierarchy (Ancestors)

Central Nervous System Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsLyme DiseaseGram-Negative Bacterial InfectionsBorrelia InfectionsSpirochaetales InfectionsCentral Nervous System InfectionsTick-Borne DiseasesVector Borne DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsCefotaximeCephacetrileCephalosporinsbeta-LactamsLactamsAmidesThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Jukka Hytönen

    University of Turku

    PRINCIPAL INVESTIGATOR

  • Elisa Kortela

    HYKS

    PRINCIPAL INVESTIGATOR

  • Mari Kanerva

    HYKS

    PRINCIPAL INVESTIGATOR

  • Laura Airas

    TYKS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
vs.prof

Study Record Dates

First Submitted

July 3, 2012

First Posted

July 9, 2012

Study Start

August 1, 2012

Primary Completion

December 31, 2017

Study Completion

December 31, 2018

Last Updated

May 13, 2019

Record last verified: 2019-05

Locations

FI(2)