Characteristics of Lyme Arthritis | NCT03510507

Studies
Characteristics of Lyme Arthritis

NCT03510507

Sponsor

University Hospital, Strasbourg, France

Status

Unknown status

Last Update Posted

Apr 27, 2018Actual

Enrollment

38Estimated

Phase

Not provided

Conditions

Lyme Arthritis

Interventions

Not provided

Countries

France

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

Jan 2018

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 20, 2018Actual

Primary Completion Date

Jan 2019Estimated

Completion Date

Jan 2019Estimated

First Submitted Date

Feb 26, 2018

First Submission Date that Met QC Criteria

Apr 26, 2018

First Posted Date

Apr 27, 2018Actual

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

Apr 26, 2018

Last Update Posted Date

Apr 27, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

Lyme disease is due to Borrelia burgdorferi sensu lato and is transmitted by a tick vector of the genus Ixodes. One of the clinical forms of this disease in the disseminated phase is the appearance of arthritis, classically mono or oligo-arthritis in the large joints.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

38Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Retrospective study of clinical and biological data of French patients with Lyme arthritis between 2011 and 2016		The period from 2011 to 2016 will be examined

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age >18 years
Diagnosis of Lyme arthritis confirmed by PCR of joint fluid at CNR Borrelia between 2011 and 2016
Patient who has agreed to use his medical data for research purposes

Exclusion Criteria:

- Refusal to participate in the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patient diagnosed with Lyme arthritis and confirmed by PCR of joint fluid at CNR Borrelia between 2011 and 2016

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Benoit JAULHAC, MD, PhD	Contact	33 3 69 55 14 52		benoit.jaulhac@chru-strasbourg.fr
Antoine GRILLON, MD	Contact	33 3 69 55 15 82		antoine.grillon@chru-strasbourg.fr

Overall Officials

Name	Affiliation	Role
Benoit JAULHAC, MD, PhD	University Hospital, Strasbourg, France	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Laboratoire de Bacteriologie - Ptm	Recruiting	Strasbourg		67091	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008193	Lyme Disease
D001168	Arthritis

Ancestor Terms

ID	Term
D016905	Gram-Negative Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided