Short 3-week Antibiotic Treatment Versus 6 Weeks in Adults With Septic Arthritis of Native Joint

Last updated: April 4, 2025
Sponsor: Assistance Publique - Hôpitaux de Paris
Overall Status: Completed

Phase

N/A

Condition

Arthritis And Arthritic Pain

Joint Injuries

Treatment

Short antibiotics treatment

Clinical Study ID

NCT03716921
P170911J
IDRCB
  • Ages > 18
  • All Genders

Study Summary

In France, the incidence of native joint infections is about 10 per 100 000 person-years, most commonly caused by S.aureus followed by b-haemolytic streptococci. French and international antibiotic guidelines, based on expert advice and retrospective studies, recommend intravenous antibiotics for two weeks, then oral for 4 weeks without evident link between intravenous, prolonged oral treatment and cure. Long term exposure to antibiotics increases bacterial resistance, a major problem of public health. Several studies show that serious infectious can be treated safely by a shorter treatment and with oral antibiotics. There is no randomized controlled trial to establish the duration of antibiotics in native joint infections. Moreover, no consensus prevails on the administration route and duration of antimicrobial therapy. Although most clinicians acknowledge the interest of oral antibiotics and shorter treatment duration, randomized controlled trials are necessary to evaluate this practice. The SHASAR project aims to evaluate whether a shorter antibiotic treatment (3 week treatment) is safe and not inferior to the conventional 6 week treatment in native joint infections. If successful, this would represent a major advance in terms of patients' quality of life; decreased rate of health-care-related infections and complications, bacterial resistance and cost.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Septic arthritis of native joint defined by: 1) clinical signs (hot and/or swollenand/or tender and painful joint (measured by a visual analogue scale)) and 2)microbiologically confirmed pyogenic arthritis (microorganism cultured in thesynovial fluid joint or in the blood with complete bacterial susceptibility)

  • Patients aged of 18 years or older

  • Informed, written consent obtained from the patient

  • Patient having the rights to French social insurance

Exclusion

Exclusion Criteria:

  • Prosthetic joints

  • Septic arthritis in the past 12 months

  • Osteomyelitis

  • Diabetic foot

  • Septic choc

  • Arthritis due to bacteria resistant to available oral antibiotics

  • Arthritis due to the following microorganisms: Mycobacterium, fungi, Brucella,Borrelia, Neisseria gonorrhoeae, Neisseria meningitidis, Nocardia, Mycoplasma spp,Pseudomonas aeruginosa.

  • Glomerular filtration rate < 30ml/min/1,73m2

  • Neutrophils < 500/mm3

  • Difficulties regarding compliance with oral antibiotics

  • Contraindication to oral antibiotics necessary to treat joint infection

  • Pregnancy or lactating woman

  • Curator or guardianship

  • Participation in other interventional research during the study

Study Design

Total Participants: 332
Treatment Group(s): 1
Primary Treatment: Short antibiotics treatment
Phase:
Study Start date:
February 05, 2019
Estimated Completion Date:
January 25, 2024

Study Description

This trial is a nationwide, non inferiority, multicenter French randomized, open-label, controlled trial comparing two treatment durations, 3 versus 6 weeks, in septic arthritis of native joints. Patients who fulfill inclusion criteria will be randomized between day0 and day5. Day 0 is the time when effective intravenous antibiotic treatment is started. Effective treatment is defined by active antibiotics on the identified bacteria according to the susceptibility. The randomisation (1:1 ratio) will be stratified on early planned drainage. Follow-up will include 6 visits and will consist in clinical, biological, radiological, health quality of life (EQ-5D-3L score) and adverse events record. After collection, validation of data and population description, analysis will be conducted on the per-protocol population (patients receiving the planned duration of antibiotic +/-3days). This study will not be carried out blind for feasibility reasons. According to statistical considerations (by accounting for 5% of subjects lost to follow-up), the required sample size will be of 350 patients overall.

Connect with a study center

  • Hôpital Avicenne - Service de Maladies Infectieuses

    Bobigny, 93000
    France

    Active - Recruiting

  • Hôpital Avicenne - Service de Rhumatologie

    Bobigny, 93000
    France

    Site Not Available

  • Hôpital Pellegrin Bordeaux - Service de Rhumatologie

    Bordeaux, 33000
    France

    Site Not Available

  • Hôpital Ambroise Paré - Service de Rhumatologie

    Boulogne-Billancourt, 92104
    France

    Site Not Available

  • Hôpital Cavale Blanche - Service de Maladies Infectieuses

    Brest, 29600
    France

    Site Not Available

  • CHG Pontoise - Centre Hospitalier René Dubos - Service de Rhumatologie

    Cergy-Pontoise, 95303
    France

    Site Not Available

  • CHU Tours - Hôpital Trousseau - Service de Rhumatologie

    Chambray-lès-Tours, 37170
    France

    Site Not Available

  • Hôpital Antoine Béclère - Service de Maladies Infectieuses

    Clamart, 92140
    France

    Site Not Available

  • CHSF - Service de Rhumatologie

    Corbeil-Essonnes, 91100
    France

    Site Not Available

  • Hôpital Henri Mondor - Service de Maladies Infectieuses

    Créteil, 94000
    France

    Site Not Available

  • Hôpital Henri Mondor - Service de Rhumatologie

    Créteil, 94000
    France

    Active - Recruiting

  • CHU Dijon Bourgogne - Hôpital François Mitterrand -Service de Maladies Infectieuses

    Dijon, 21079
    France

    Site Not Available

  • Hôpital Raymond Poincaré - Service de Maladies Infectieuses

    Garches, 92380
    France

    Site Not Available

  • CHU Grenoble Alpes - Hôpital Michallon - Service de Maladies Infectieuses

    La Tronche, 38700
    France

    Site Not Available

  • Hopital Bicêtre, Service de Maladies Infectieuses et Tropicales

    Le Kremlin-Bicêtre, 94270
    France

    Site Not Available

  • Hôpital Bicêtre service de rhumatologie

    Le Kremlin-Bicêtre, 94270
    France

    Site Not Available

  • CHRU Lille - Service de Rhumatologie

    Lille, 59037
    France

    Site Not Available

  • CHR Orléans - Service de Rhumatologie

    Orléans, 45100
    France

    Site Not Available

  • GH Diaconesse La Croix St Simon - Service de Rhumatologie

    Paris, 75020
    France

    Site Not Available

  • Hôpital Bichat - Service de Maladies Infectieuses

    Paris, 75018
    France

    Active - Recruiting

  • Hôpital Bichat - Service de Rhumatologie

    Paris, 75018
    France

    Site Not Available

  • Hôpital Cochin - Service de Maladies Infectieuses

    Paris, 75014
    France

    Site Not Available

  • Hôpital Cochin - Service de Rhumatologie

    Paris, 75014
    France

    Site Not Available

  • Hôpital Lariboisière Service de Rhumatologie

    Paris, 75010
    France

    Site Not Available

  • Hôpital Necker - Service de Maladies Infectieuses

    Paris, 75015
    France

    Active - Recruiting

  • Hôpital Pitié Salpetrière - Service de Maladies Infectieuses

    Paris, 75013
    France

    Site Not Available

  • Hôpital Pitié Salpetrière - Service de Rhumatologie

    Paris, 75013
    France

    Site Not Available

  • Hôpital Saint Antoine - Service de Rhumatologie

    Paris, 75012
    France

    Site Not Available

  • Hôpital Tenon - Service de Maladies Infectieuses

    Paris, 75020
    France

    Active - Recruiting

  • Hôpital Sud Rennes - Service de Rhumatologie

    Rennes,
    France

    Site Not Available

  • CHU Saint Etienne - Hôpital Nord - Service de Maladies Infectieuses

    Saint-Priest-en-Jarez, 42270
    France

    Site Not Available

  • CHU Saint Etienne - Hôpital Nord - Service de Rhumatologie

    Saint-Priest-en-Jarez, 42270
    France

    Site Not Available

  • CHRU Strasbourg - Hôpital de Hautepierre - Service de Rhumatologie

    Strasbourg, 67200
    France

    Site Not Available

  • CHU Tours - Hôpital Bretonneau - Service de Maladies Infectieuses

    Tours, 37044
    France

    Site Not Available

  • Hôpitaux de Brabois - Service de Maladies Infectieuses

    Vandœuvre-lès-Nancy, 54500
    France

    Site Not Available

  • Hôpitaux de Brabois - Service de Rhumatologie

    Vandœuvre-lès-Nancy, 54500
    France

    Site Not Available

  • CHU Grenoble Alpes - Hôpital Sud - Service de Rhumatologie

    Échirolles, 38130
    France

    Site Not Available

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