Study on Early Lyme Neuroborreliosis

NCT ID: NCT00910533

Last Updated: 2018-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-01

Study Completion Date

2020-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to determine clinical course and the sequelae of early Lyme neuroborreliosis after treatment with ceftriaxone.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Nervous System Lyme Borreliosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Early Lyme neuroborreliosis patients

Group Type ACTIVE_COMPARATOR

ceftriaxone

Intervention Type DRUG

ceftriaxone 2 g od i.v. for 14 days

control subjects

Control subjects without a history of Lyme borreliosis.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ceftriaxone

ceftriaxone 2 g od i.v. for 14 days

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* erythema migrans within 4 months before neurologic involvement and pleocytosis in patients \>15 years old

Exclusion Criteria

* pregnancy
* lactation
* history of adverse reaction to a beta-lactam antibiotic
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Medical Centre Ljubljana

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Franc Strle

M.D., PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Franc Strle, MD

Role: STUDY_CHAIR

UMC Ljubljana

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

UMC Ljubljana, Department of Infectious Diseases

Ljubljana, , Slovenia

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Slovenia

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Dasa Stupica, MD

Role: CONTACT

+38615222110

Franc Strle, MD

Role: CONTACT

+38615222110

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Dasa Stupica, MD

Role: primary

+386 1 522 2110

Franc Strle, MD

Role: backup

+386 1 5222610

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

LNB-0509

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Ceftriaxone for Post-Treatment Lyme Disease
NCT06785402 RECRUITING PHASE1/PHASE2