NCT00138801

Brief Summary

The aim of this study is to compare parenteral ceftriaxone and oral doxycycline in the treatment of neuroborreliosis in a randomized controlled trial.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2004

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

March 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 29, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 30, 2005

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

May 6, 2023

Status Verified

March 1, 2005

Enrollment Period

4 years

First QC Date

August 29, 2005

Last Update Submit

May 3, 2023

Conditions

Lyme Neuroborreliosis

Keywords

Neuroborreliosis

Study Arms (2)

1

ACTIVE COMPARATOR

Doxycycline

Drug: Doxycycline

2

ACTIVE COMPARATOR

cephtriaxone

Drug: Ceftriaxone

Interventions

CeftriaxoneDRUG
2
DoxycyclineDRUG
1

Eligibility Criteria

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

You may qualify if:

  • Neurological symptoms and/or findings consistent with neuroborreliosis and at least one of the following fulfilled:
  • Intrathecal production of borrelia antibodies;
  • White cell count in cerebrospinal fluid (CSF) \> 5/mm3;
  • Significant rise in borrelia antibodies in two serum samples collected from a patient with at least 3 weeks interval;
  • Verified acrodermatitis chronica atrophicans.

You may not qualify if:

  • Allergy to the contents in the medication, or earlier type I reaction to penicillin.
  • Treatment with cephalosporins, penicillin or tetracyclins during the last 14 days
  • Pregnancy or breastfeeding
  • Age \< 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sørlandet Sykehus HF

Kristiansand, Vest-Agder, 4633, Norway

Location

Related Publications (1)

  • Ljostad U, Skogvoll E, Eikeland R, Midgard R, Skarpaas T, Berg A, Mygland A. Oral doxycycline versus intravenous ceftriaxone for European Lyme neuroborreliosis: a multicentre, non-inferiority, double-blind, randomised trial. Lancet Neurol. 2008 Aug;7(8):690-5. doi: 10.1016/S1474-4422(08)70119-4. Epub 2008 Jun 21.

    PMID: 18567539DERIVED

MeSH Terms

Conditions

Lyme Neuroborreliosis

Interventions

CeftriaxoneDoxycycline

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)

CefotaximeCephacetrileCephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsTetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Officials

  • Åse Mygland, MD, PhD

    Sorlandet Sykehus HF

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2005

First Posted

August 30, 2005

Study Start

March 1, 2004

Primary Completion

March 1, 2008

Study Completion

December 1, 2008

Last Updated

May 6, 2023

Record last verified: 2005-03

Locations

NO(1)