Study on Early Lyme Neuroborreliosis | NCT00910533

Studies
Study on Early Lyme Neuroborreliosis

NCT00910533

Sponsor

University Medical Centre Ljubljana

Status

Unknown status

Last Update Posted

Oct 16, 2018Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Nervous System Lyme Borreliosis

Interventions

ceftriaxone

Countries

Slovenia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2009

Primary Completion Date

Dec 31, 2018Estimated

Completion Date

Dec 2020Estimated

First Submitted Date

May 28, 2009

First Submission Date that Met QC Criteria

May 28, 2009

First Posted Date

Jun 1, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 15, 2018

Last Update Posted Date

Oct 16, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Franc Strle, M.D., PhD, University Medical Centre LjubljanaPrincipal Investigator

Lead Sponsor

University Medical Centre LjubljanaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Early Lyme neuroborreliosis patients	Active Comparator		Drug: ceftriaxone
control subjects	No Intervention	Control subjects without a history of Lyme borreliosis.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ceftriaxone	Drug	ceftriaxone 2 g od i.v. for 14 days	Early Lyme neuroborreliosis patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Objective sequelae and post-treatment subjective symptoms in patients treated with ceftriaxone for early Lyme neuroborreliosis		1 year follow-up

Secondary Outcomes

Measure	Description	Time Frame
Comparison of subjective symptoms between patients treated with ceftriaxone for early Lyme neuroborreliosis and control subjects without a history of Lyme borreliosis		1 year follow-up

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dasa Stupica, MD	Contact	+38615222110		cerar.dasa@gmail.com
Franc Strle, MD	Contact	+38615222110		franc.strle@kclj.si

Overall Officials

Name	Affiliation	Role
Franc Strle, MD	UMC Ljubljana	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UMC Ljubljana, Department of Infectious Diseases	Recruiting	Ljubljana		1525	Slovenia

Condition Browse Module

MeSH Terms

ID	Term
D020852	Lyme Neuroborreliosis

Ancestor Terms

ID	Term
D020806	Central Nervous System Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002443	Ceftriaxone

Ancestor Terms

ID	Term
D002439	Cefotaxime
D002505	Cephacetrile
D002511	Cephalosporins
D047090	beta-Lactams

Browse Leaves

Not provided

Browse Branches

Not provided