Gonococcal (GC) InfectionEpGArNCT06897943
Epidemiology of Gonococcal Arthritis (EpGAr)
An observational study of Gonococcal (GC) Infection and Arthritis, Infectious, run by University Hospital, Brest at 2 sites in France.
Trial summary
The aim of this retrospective observational study was to describe the epidemiology of Neisseria gonorrhoeae septic arthritis over the last 10 years at Brest and Rennes university hospitals. The main question is whether there are any risk factors based on the epidemiological and clinical data on these cases. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gonococcal (GC) Infection, Arthritis, Infectious
- How many people
- 11 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Dec 2024to 30 Apr 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with a Neisseria gonorrhoeae-positive joint sample (from an enrichment vial or a native sample) between 06/01/2014 and 06/30/2024.
Who may be able to join
- Patients with a Neisseria gonorrhoeae-positive joint sample (from an enrichment vial or a native sample) between 2014 and 2024.
Who cannot join
- Patients with Neisseria gonorrhoeae-negative joint sample (from enrichment vial or native sample).
- Patients who have expressed opposition to inclusion in the study.
- Patients under legal protection (guardianship, curatorship, etc.).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Valentin LEMOINE contact
France2 sites, 2 recruiting
- Recruiting
CHU de BREST
Brest, 29609
Geneviève HERY-ARNAUD, +33298145107, genevieve.hery-arnaud@univ-brest.fr
Valentin LEMOINE
- Recruiting
Rennes University Hospital
Rennes, Brittany Region, 35000
Vincent CATTOIR, +33 2 99 28 98 28, vincent.cattoir@chu-rennes.fr
Vincent CATTOIR
About this study
Official title: Epidemiology of Gonococcal Arthritis
The aim of this retrospective observational study was to describe the epidemiology of Neisseria gonorrhoeae septic arthritis over the last 10 years at Brest and Rennes university hospitals. The main question is whether there are any risk factors based on the epidemiological and clinical data on these cases. The second objective is to characterize the gonococcal strains isolated in order to determine whether there is a common clone, a virulence factor or specific resistance genes.
- Conditions
- Gonococcal (GC) Infection, Arthritis, Infectious
- Keywords
- gonococcal arthritis
- Medical subject headings
- Gonorrhea, Infections, Arthritis, Infectious
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Gonococcal arthritis | Patients with a positive joint sample for Neisseria gonorrhoeae between 06/01/2014 and 06/30/2024 in Brittany, France. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Age
years
Measured: 10 years
Date of sampling
DD/MM/YYYY
Measured: 10 years
Type of sample
joint fluid or joint fluid on blood culture bottle
Measured: 10 years
Rate of white blood cells
quantification of white blood cells /mm3
Measured: 10 years
Sexually transmitted infection
associated or not, if associated, name of STI and localization
Measured: 10 years
Men who have sex with men
yes or no
Measured: 10 years
HIV pre-exposure prophylaxis (PreP)
yes or no
Measured: 10 years
Comorbidities
any history mentioned in the medical file, such as fracture, illness, treatment, chronic alcoholism, cancer, diabetes, etc.
Measured: 10 years
Imaging
medical conclusion of the ultrasound or radiology performed
Measured: 10 years
Blood cultures (peripheral blood)
positive or negative
Measured: 10 years
Time to diagnosis
in days (between onset of symptoms and antibiotics)
Measured: 10 years
Treatments implemented
name of the probabilistic treatment (antibiotic) and after identification or antibiogram
Measured: 10 years
Antibiotic sensitivity profile
Susceptibility or resistance according to SIR methodology and, if achieved: minimum inhibitory concentrations of antibiotics tested on the strain in mg/L
Measured: 10 years
Surgery
yes or not
Measured: 10 years
Evolution
recovery or relapse
Measured: 10 years
Rate of neutrophils
proportion of neutrophils in %.
Measured: 10 years
Rate of CRP (C-reactive protein)
in mg/L
Measured: 10 years
Secondary outcomes (3)
Molecular typing: clone
performed on strains sent to the Centre National de Référence des IST - APHP
Measured: 10 years
Molecular typing: virulence factors
performed on strains sent to the Centre National de Référence des IST - APHP
Measured: 10 years
Molecular typing: resistance genes
performed on strains sent to the Centre National de Référence des IST - APHP
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study start1 Dec 2024
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gonococcal (GC) InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- 11 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Geneviève HERY-ARNAUD, Principal investigator, CHU de Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06897943
- Sponsor's protocol ID
- 29BRC24.0339 - EpGAr
- Acronym
- EpGAr
- Status last verified
- Dec 2024
- First submitted
- 10 Mar 2025
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Gonococcal Arthritis
- ClinicalTrials.gov ID
- NCT06897943
- Acronym / sponsor ID
- EpGAr / 29BRC24.0339 - EpGAr
- Conditions
- Gonococcal (GC) Infection, Arthritis, Infectious
- Keywords
- gonococcal arthritis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 11 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 27 Mar 2025 (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.
The aim of this retrospective observational study was to describe the epidemiology of Neisseria gonorrhoeae septic arthritis over the last 10 years at Brest and Rennes university hospitals. The main question is whether there are any risk factors based on the epidemiological and clinical data on these cases. The second objective is to characterize the gonococcal strains isolated in order to determine whether there is a common clone, a virulence factor or specific resistance genes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gonococcal arthritis | – | –Patients with a positive joint sample for Neisseria gonorrhoeae between 06/01/2014 and 06/30/2024 in Brittany, France. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with a Neisseria gonorrhoeae-positive joint sample (from an enrichment vial or a native sample) between 06/01/2014 and 06/30/2024.
Key inclusion criteria (1 listed)
- Patients with a Neisseria gonorrhoeae-positive joint sample (from an enrichment vial or a native sample) between 2014 and 2024.
Key exclusion criteria (3 listed)
- Patients with Neisseria gonorrhoeae-negative joint sample (from enrichment vial or native sample).
- Patients who have expressed opposition to inclusion in the study.
- Patients under legal protection (guardianship, curatorship, etc.).
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
Age
Time frame: 10 years
years
Date of sampling
Time frame: 10 years
DD/MM/YYYY
Type of sample
Time frame: 10 years
joint fluid or joint fluid on blood culture bottle
Rate of white blood cells
Time frame: 10 years
quantification of white blood cells /mm3
Sexually transmitted infection
Time frame: 10 years
associated or not, if associated, name of STI and localization
Men who have sex with men
Time frame: 10 years
yes or no
HIV pre-exposure prophylaxis (PreP)
Time frame: 10 years
yes or no
Comorbidities
Time frame: 10 years
any history mentioned in the medical file, such as fracture, illness, treatment, chronic alcoholism, cancer, diabetes, etc.
Imaging
Time frame: 10 years
medical conclusion of the ultrasound or radiology performed
Blood cultures (peripheral blood)
Time frame: 10 years
positive or negative
Time to diagnosis
Time frame: 10 years
in days (between onset of symptoms and antibiotics)
Treatments implemented
Time frame: 10 years
name of the probabilistic treatment (antibiotic) and after identification or antibiogram
Antibiotic sensitivity profile
Time frame: 10 years
Susceptibility or resistance according to SIR methodology and, if achieved: minimum inhibitory concentrations of antibiotics tested on the strain in mg/L
Surgery
Time frame: 10 years
yes or not
Evolution
Time frame: 10 years
recovery or relapse
Rate of neutrophils
Time frame: 10 years
proportion of neutrophils in %.
Rate of CRP (C-reactive protein)
Time frame: 10 years
in mg/L
3 secondary outcomes
Molecular typing: clone
Time frame: 10 years
Molecular typing: virulence factors
Time frame: 10 years
Molecular typing: resistance genes
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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.
Valentin LEMOINE contact
Geneviève HERY-ARNAUD principal investigator
CHU de Brest
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gonococcal (GC) Infection and Arthritis, Infectious, run by University Hospital, Brest at 2 sites 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 1 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Geneviève HERY-ARNAUD (0298145107 ext. +33, genevieve.hery-arnaud@univ-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Age (time frame: 10 years). The study lists 17 primary outcomes in all. 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 Mar 2025.