Epidemiology of Gonococcal Arthritis (EpGAr) (EpGAr)

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.

Study Overview

• Status: Recruiting
• Conditions: Arthritis, Infectious; Gonococcal (GC) Infection

• Study Type: Observational
• Enrollment (Estimated): 11

Contacts and Locations

• Study Contact: Name: Geneviève HERY-ARNAUD; Phone Number: +33 0298145107; Email: genevieve.hery-arnaud@univ-brest.fr
• Study Contact Backup: Name: Valentin LEMOINE; Email: valentin.lemoine@chu-brest.fr

Study Locations

• France
  • Brest, France, 29609
    • Recruiting
    • CHU de Brest
    • Contact: Geneviève HERY-ARNAUD; Phone Number: +33298145107; Email: genevieve.hery-arnaud@univ-brest.fr
    • Contact: Valentin LEMOINE
    • Contact: Geneviève HERY-ARNAUD
  • Brittany
    • Rennes, Brittany, France, 35000
      • Recruiting
      • Rennes University Hospital
      • Contact: Vincent CATTOIR; Phone Number: +33 2 99 28 98 28; Email: vincent.cattoir@chu-rennes.fr
      • Contact: Vincent CATTOIR

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• Patients with a Neisseria gonorrhoeae-positive joint sample (from an enrichment vial or a native sample) between 2014 and 2024.

Exclusion Criteria:

• 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.).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Gonococcal arthritis; Patients with a positive joint sample for Neisseria gonorrhoeae between 06/01/2014 and 06/30/2024 in Brittany, France.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age	years	10 years
Date of sampling	DD/MM/YYYY	10 years
Type of sample	joint fluid or joint fluid on blood culture bottle	10 years
Rate of white blood cells	quantification of white blood cells /mm3	10 years
Sexually transmitted infection	associated or not, if associated, name of STI and localization	10 years
Men who have sex with men	yes or no	10 years
HIV pre-exposure prophylaxis (PreP)	yes or no	10 years
Comorbidities	any history mentioned in the medical file, such as fracture, illness, treatment, chronic alcoholism, cancer, diabetes, etc.	10 years
Imaging	medical conclusion of the ultrasound or radiology performed	10 years
Blood cultures (peripheral blood)	positive or negative	10 years
Time to diagnosis	in days (between onset of symptoms and antibiotics)	10 years
Treatments implemented	name of the probabilistic treatment (antibiotic) and after identification or antibiogram	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	10 years
Surgery	yes or not	10 years
Evolution	recovery or relapse	10 years
Rate of neutrophils	proportion of neutrophils in %.	10 years
Rate of CRP (C-reactive protein)	in mg/L	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Molecular typing: clone	performed on strains sent to the Centre National de Référence des IST - APHP	10 years
Molecular typing: virulence factors	performed on strains sent to the Centre National de Référence des IST - APHP	10 years
Molecular typing: resistance genes	performed on strains sent to the Centre National de Référence des IST - APHP	10 years

Collaborators and Investigators

• Sponsor: University Hospital, Brest
• Investigators: Principal Investigator: Geneviève HERY-ARNAUD, CHU de Brest

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2024
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: March 10, 2025
• First Submitted That Met QC Criteria: March 20, 2025
• First Posted (Actual): March 27, 2025

Study Record Updates

• Last Update Posted (Actual): March 27, 2025
• Last Update Submitted That Met QC Criteria: March 20, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: gonococcal arthritis
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Musculoskeletal Diseases; Joint Diseases; Infections; Communicable Diseases; Sexually Transmitted Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Negative Bacterial Infections; Sexually Transmitted Diseases, Bacterial; Neisseriaceae Infections; Arthritis; Arthritis, Infectious; Gonorrhea
• Other Study ID Numbers: 29BRC24.0339 - EpGAr

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected data that underlie results in a publication
• IPD Sharing Time Frame: Data will be available beginning three years and ending fifteen years following the final study report completion
• IPD Sharing Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No