Doxycycline and Ceftriaxone in Suspected Early Lyme Neuro... | NCT00942006

Studies
Doxycycline and Ceftriaxone in Suspected Early Lyme Neuroborreliosis

NCT00942006

Sponsor

University Medical Centre Ljubljana

Status

Unknown status

Last Update Posted

Jul 20, 2009Estimated

Enrollment

200Estimated

Phase

Not Applicable

Conditions

Suspected Early Lyme Neuroborreliosis

Interventions

doxycycline
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

Jul 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2009

Primary Completion Date

Nov 2010Estimated

Completion Date

Nov 2011Estimated

First Submitted Date

Jul 17, 2009

First Submission Date that Met QC Criteria

Jul 17, 2009

First Posted Date

Jul 20, 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

Jul 17, 2009

Last Update Posted Date

Jul 20, 2009Estimated

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 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.

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

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
LNB-doxycycline	Active Comparator		Drug: doxycycline
LNB-ceftriaxone	Active Comparator		Drug: ceftriaxone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
doxycycline	Drug	100 mg bid, 14 days	LNB-doxycycline
ceftriaxone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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).

Exclusion Criteria:

pregnancy
lactation
allergy on doxycycline and ceftriaxone
immune deficiency.

Accepts Healthy Volunteers

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
Katarina Ogrinc, MD PhD	Contact	+386 1 522 4217		katarina.ogrinc1@guest.arnes.si
Franc Strle, PhD MD	Contact	+386 1 522 2110		franc.strle@kclj.si

Overall Officials

Name	Affiliation	Role
Franc Strle, MD PhD	UMC Ljubljana	Study Chair

Locations

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

Condition Browse Module

MeSH Terms

ID	Term
D020852	Lyme Neuroborreliosis
D008193	Lyme Disease
D005929	Glossitis, Benign Migratory

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
D004318	Doxycycline
D002443	Ceftriaxone

Ancestor Terms

ID	Term
D013754	Tetracyclines
D009279	Naphthacenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic

Browse Leaves

Not provided

Browse Branches

Not provided