Lyme ArthritisArthLymeNCT03510507
Characteristics of Lyme Arthritis
An observational study of Lyme Arthritis, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lyme Arthritis
- How many people
- 38 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jan 2018to Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient diagnosed with Lyme arthritis and confirmed by PCR of joint fluid at CNR Borrelia between 2011 and 2016
Who may be able to join
- 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
Who cannot join
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Laboratoire de Bacteriologie - Ptm
Strasbourg, 67091
Benoit JAULHAC, MD, PhD, 33 3 69 55 14 52, benoit.jaulhac@chru-strasbourg.fr
Antoine GRILLON, MD, 33 3 69 55 15 82, antoine.grillon@chru-strasbourg.fr
About this study
Official title: Characteristics of Positive Lyme PCR Arthritis, Data From CNR Borrelia 2011-2016
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.
- Conditions
- Lyme Arthritis
- Keywords
- Lyme arthritis, Borrelia burgdorferi, vector tick, Arthritis, joints
- Medical subject headings
- Lyme Disease, Arthritis
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective study of clinical and biological data of French patients with Lyme arthritis between 2011 and 2016
Measured: The period from 2011 to 2016 will be examined
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2018
- Study start20 Jan 2018
- Primary completionJan 2019 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lyme ArthritisStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benoit JAULHAC, MD, PhD, Study director, University Hospital, Strasbourg, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03510507
- Sponsor's protocol ID
- 6971
- Acronym
- ArthLyme
- Status last verified
- Jan 2018
- First submitted
- 26 Feb 2018
- Last updated
- 27 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics of Positive Lyme PCR Arthritis, Data From CNR Borrelia 2011-2016
- ClinicalTrials.gov ID
- NCT03510507
- Acronym / sponsor ID
- ArthLyme / 6971
- Conditions
- Lyme Arthritis
- Keywords
- Lyme arthritis, Borrelia burgdorferi, vector tick, Arthritis, joints
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 20 Jan 2018 (actual)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 27 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient diagnosed with Lyme arthritis and confirmed by PCR of joint fluid at CNR Borrelia between 2011 and 2016
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Refusal to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Retrospective study of clinical and biological data of French patients with Lyme arthritis between 2011 and 2016
Time frame: The period from 2011 to 2016 will be examined
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benoit JAULHAC, MD, PhD study director
University Hospital, Strasbourg, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lyme Arthritis, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Benoit JAULHAC, MD, PhD (33 3 69 55 14 52, benoit.jaulhac@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retrospective study of clinical and biological data of French patients with Lyme arthritis between 2011 and 2016 (time frame: The period from 2011 to 2016 will be examined). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2018.