Epidemiology of Gonococcal Arthritis (EpGAr)

NCT06897943 | Recruiting

• 1 other identifier: 29BRC24.0339 - EpGAr
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 2

Brief 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. 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

Outcome Measures

Primary Outcomes (17)

• 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 Outcomes (3)

• Molecular typing: clone

  10 years

• Molecular typing: virulence factors

  10 years

• Molecular typing: resistance genes

  10 years

Study Arms (1)

Gonococcal arthritis

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Patients with Neisseria gonorrhoeae-negative joint sample (from enrichment vial or native sample).
• Patients under legal protection (guardianship, curatorship, etc.).

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (2)

Rennes University Hospital

Rennes, Brittany Region, 35000, France

RECRUITING

CHU de BREST

Brest, 29609, France

RECRUITING

MeSH Terms

Conditions

Gonorrhea; Infections; Arthritis, Infectious

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases; Arthritis; Joint Diseases; Musculoskeletal Diseases

Study Officials

• Geneviève HERY-ARNAUD

  CHU de Brest

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Geneviève HERY-ARNAUD

CONTACT

0298145107; genevieve.hery-arnaud@univ-brest.fr

Valentin LEMOINE

CONTACT

valentin.lemoine@chu-brest.fr

Study Design

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

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 27, 2025
• Study Start: December 1, 2024
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: March 27, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning three years and ending fifteen years following the final study report completion
• 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

Locations

FR (2)