NCT00942006

Brief Summary

The investigators will compare doxycycline and ceftriaxone in treatment of patients with suspected early Lyme neuroborreliosis and normal CSF cell count. The study hypothesis is that the efficacy and adverse effects of both antibiotics are comparable.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

July 1, 2009

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

July 17, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 20, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

July 20, 2009

Status Verified

July 1, 2009

Enrollment Period

1.3 years

First QC Date

July 17, 2009

Last Update Submit

July 17, 2009

Conditions

Suspected Early Lyme Neuroborreliosis

Keywords

Lyme neuroborreliosisLyme borreliosiserythema migransdoxycycline treatmentceftriaxone treatmentoutcomesubjective symptoms

Outcome Measures

Primary Outcomes (1)

  • Objective sequelae and post-treatment subjective symptoms in patients treated for suspected early Lyme neuroborreliosis with normal CSF cell count with doxycycline or ceftriaxone for 14 days.

    1 year follow-up

Study Arms (2)

LNB-doxycycline

ACTIVE COMPARATOR
Drug: doxycycline

LNB-ceftriaxone

ACTIVE COMPARATOR
Drug: ceftriaxone

Interventions

doxycyclineDRUG

100 mg bid, 14 days

LNB-doxycycline
ceftriaxoneDRUG

2g x 1 iv, 14 days

LNB-ceftriaxone

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • age \>15 years
  • erythema migrans in 4 months period before neurologic symptoms
  • normal CSF cell count
  • absence of more defined clinical symptoms or signs for CNS involvement (radicular pain, meningeal signs, peripheral facial palsy).

You may not qualify if:

  • pregnancy
  • lactation
  • allergy on doxycycline and ceftriaxone
  • immune deficiency.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMC Ljubljana, Department of Infectious Diseases

Ljubljana, 1525, Slovenia

Location

MeSH Terms

Conditions

Lyme NeuroborreliosisLyme DiseaseGlossitis, Benign Migratory

Interventions

DoxycyclineCeftriaxone

Condition Hierarchy (Ancestors)

Central Nervous System Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsGram-Negative Bacterial InfectionsBorrelia InfectionsSpirochaetales InfectionsCentral Nervous System InfectionsTick-Borne DiseasesVector Borne DiseasesCentral Nervous System DiseasesNervous System DiseasesGlossitisTongue DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Franc Strle, MD PhD

    UMC Ljubljana

    STUDY CHAIR

Central Study Contacts

Katarina Ogrinc, MD PhD

CONTACT

+386 1 522 4217katarina.ogrinc1@guest.arnes.si

Franc Strle, PhD MD

CONTACT

+386 1 522 2110franc.strle@kclj.si

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 17, 2009

First Posted

July 20, 2009

Study Start

July 1, 2009

Primary Completion

November 1, 2010

Study Completion

November 1, 2011

Last Updated

July 20, 2009

Record last verified: 2009-07

Locations

SL(1)