NCT03510507

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 20, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 26, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 27, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

April 27, 2018

Status Verified

January 1, 2018

Enrollment Period

12 months

First QC Date

February 26, 2018

Last Update Submit

April 26, 2018

Conditions

Lyme Arthritis

Keywords

Lyme arthritisBorrelia burgdorferivector tickArthritisjoints

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • \- Refusal to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratoire de Bacteriologie - Ptm

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Lyme DiseaseArthritis

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsBorrelia InfectionsSpirochaetales InfectionsTick-Borne DiseasesVector Borne DiseasesJoint DiseasesMusculoskeletal Diseases

Study Officials

  • Benoit JAULHAC, MD, PhD

    University Hospital, Strasbourg, France

    STUDY DIRECTOR

Central Study Contacts

Benoit JAULHAC, MD, PhD

CONTACT

33 3 69 55 14 52benoit.jaulhac@chru-strasbourg.fr

Antoine GRILLON, MD

CONTACT

33 3 69 55 15 82antoine.grillon@chru-strasbourg.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2018

First Posted

April 27, 2018

Study Start

January 20, 2018

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

April 27, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)