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

Not Applicable

Completed

• Conditions: Septic Arthritis
• Interventions: Other: Short antibiotics treatment

• Registration Number: NCT03716921
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2018-10-10
• Study First Submitted QC: 2018-10-22
• Study First Posted: 2018-10-23
• Study Start: 2019-02-05
• Primary Completion: 2023-08-04
• Study Completion: 2024-01-25
• Status Verified: 2025-03
• Last Update Submitted: 2025-04-04
• Last Update Posted: 2025-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 332

Inclusion Criteria

• Septic arthritis of native joint defined by: 1) clinical signs (hot and/or swollen and/or tender and painful joint (measured by a visual analogue scale)) and 2) microbiologically confirmed pyogenic arthritis (microorganism cultured in the synovial 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 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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Short antibiotics treatment	Short antibiotics treatment	patients will receive effective antibiotic treatment (IV and oral) for 3 weeks

Primary Outcome Measures

Name	Time	Method
Cure at 16 weeks (4 months) after the beginning of the treatment	16 weeks after Day 0	Cure is defined as absence of clinical signs of joint infection, absence of treatment failure, absence of relapse

Secondary Outcome Measures

Name	Time	Method
Cure at 24 weeks	24 weeks after Day 0	Cure is defined as absence of clinical signs of joint infection, absence of treatment failure, absence of relapse
joint mobility	at 16 and 24 weeks after Day 0	joint mobility is assessed by "good mobility, few mobility, no mobility"
Treatment failure and relapse and relapse rates	6,16,24 weeks after Day 0	% of relapse at 6,16,24 weeks
hospital length of stay and total treatments costs	through study completion, an average of 3 years	To compare cost-effectiveness and cost utility of 3-week vs 6-week antibiotic strategies for patients with arthritis of native joints
The patient's quality of life	3,6,16,24 weeks after Day 0	assessed by a quality of life questionnaire on 3,6,16,24 weeks. The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
The residual joint pain in the affected joint	at 16 and 24 weeks after Day 0	The residual joint pain is measured by a numerical scale. 0 means "no pain at all" and 10 "pain as bad as it could be".

Trial Locations

Locations (31)

Hôpital Avicenne - Service de Rhumatologie; 🇫🇷 Bobigny, France

Hôpital Pellegrin Bordeaux - Service de Rhumatologie; 🇫🇷 Bordeaux, France

Hôpital Ambroise Paré - Service de Rhumatologie; 🇫🇷 Boulogne-Billancourt, France

Hôpital Cavale Blanche - Service de Maladies Infectieuses; 🇫🇷 Brest, France

CHG Pontoise - Centre Hospitalier René Dubos - Service de Rhumatologie; 🇫🇷 Cergy-Pontoise, France

CHU Tours - Hôpital Trousseau - Service de Rhumatologie; 🇫🇷 Chambray-lès-Tours, France

Hôpital Antoine Béclère - Service de Maladies Infectieuses; 🇫🇷 Clamart, France

CHSF - Service de Rhumatologie; 🇫🇷 Corbeil-Essonnes, France

CHU Dijon Bourgogne - Hôpital François Mitterrand -Service de Maladies Infectieuses; 🇫🇷 Dijon, France

Hôpital Raymond Poincaré - Service de Maladies Infectieuses; 🇫🇷 Garches, France

CHU Grenoble Alpes - Hôpital Michallon - Service de Maladies Infectieuses; 🇫🇷 La Tronche, France

Hopital Bicêtre, Service de Maladies Infectieuses et Tropicales; 🇫🇷 Le Kremlin-Bicêtre, France

Hôpital Bicêtre service de rhumatologie; 🇫🇷 Le Kremlin-Bicêtre, France

CHRU Lille - Service de Rhumatologie; 🇫🇷 Lille, France

CHR Orléans - Service de Rhumatologie; 🇫🇷 Orléans, France

Hôpital Lariboisière Service de Rhumatologie; 🇫🇷 Paris, France

Hôpital Saint Antoine - Service de Rhumatologie; 🇫🇷 Paris, France

Hôpital Pitié Salpetrière - Service de Maladies Infectieuses; 🇫🇷 Paris, France

Hôpital Pitié Salpetrière - Service de Rhumatologie; 🇫🇷 Paris, France

Hôpital Cochin - Service de Maladies Infectieuses; 🇫🇷 Paris, France

Hôpital Cochin - Service de Rhumatologie; 🇫🇷 Paris, France

Hôpital Bichat - Service de Rhumatologie; 🇫🇷 Paris, France

GH Diaconesse La Croix St Simon - Service de Rhumatologie; 🇫🇷 Paris, France

Hôpital Sud Rennes - Service de Rhumatologie; 🇫🇷 Rennes, France

CHU Saint Etienne - Hôpital Nord - Service de Maladies Infectieuses; 🇫🇷 Saint-Priest-en-Jarez, France

CHU Saint Etienne - Hôpital Nord - Service de Rhumatologie; 🇫🇷 Saint-Priest-en-Jarez, France

CHRU Strasbourg - Hôpital de Hautepierre - Service de Rhumatologie; 🇫🇷 Strasbourg, France

CHU Tours - Hôpital Bretonneau - Service de Maladies Infectieuses; 🇫🇷 Tours, France

Hôpitaux de Brabois - Service de Maladies Infectieuses; 🇫🇷 Vandœuvre-lès-Nancy, France

Hôpitaux de Brabois - Service de Rhumatologie; 🇫🇷 Vandœuvre-lès-Nancy, France

CHU Grenoble Alpes - Hôpital Sud - Service de Rhumatologie; 🇫🇷 Échirolles, France