Effect of Intravenous Ceftriaxone and Oral Doxycycline fo... | NCT00138801

Studies
Effect of Intravenous Ceftriaxone and Oral Doxycycline for Lyme Neuroborreliosis

NCT00138801

Sponsor

Sorlandet Hospital HF

Status

Completed

Last Update Posted

May 6, 2023Actual

Enrollment

120Actual

Phase

Phase 3

Conditions

Lyme Neuroborreliosis

Interventions

Ceftriaxone
Doxycycline

Countries

Norway

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

Mar 2005

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2004

Primary Completion Date

Mar 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

Aug 29, 2005

First Submission Date that Met QC Criteria

Aug 29, 2005

First Posted Date

Aug 30, 2005Estimated

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

May 3, 2023

Last Update Posted Date

May 6, 2023Actual

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

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

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Doxycycline	Drug: Doxycycline
2	Active Comparator	cephtriaxone	Drug: Ceftriaxone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ceftriaxone	Drug		2
Doxycycline

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Åse Mygland, MD, PhD	Sorlandet Sykehus HF	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sørlandet Sykehus HF		Kristiansand	Vest-Agder	4633	Norway

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18567539	Derived	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.

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

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