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

Septic Arthritis Clinical Trial

— SHASAR  

Official title:

Short 3-week Antibiotic Treatment Versus 6 Weeks in Adults With Septic Arthritis of Native Joint: a Randomized, Open Label, Non-inferiority Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03716921
• Other study ID #: P170911J
• Secondary ID: IDRCB
• Status: Recruiting
• Phase: N/A
• Start date: February 5, 2019
• Est. completion date: August 2024

Study information

• Verified date: June 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Lélia ESCAUT, Dr
• Phone: 01 45 21 74 26
• Email: lelia.escaut[@]aphp.Fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: August 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Infectious
• Septic Arthritis

Intervention

Other:
• Short antibiotics treatment
Patients randomized in this arm will pursue antibiotic administration until visit 3 weeks after D0

Locations

Country	Name	City	State
France	Hôpital Avicenne - Service de Maladies Infectieuses	Bobigny
France	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	Hôpital Henri Mondor - Service de Maladies Infectieuses	Créteil
France	Hôpital Henri Mondor - Service de Rhumatologie	Créteil
France	CHU Dijon Bourgogne - Hôpital François Mitterrand -Service de Maladies Infectieuses	Dijon
France	CHU Grenoble Alpes - Hôpital Sud - Service de Rhumatologie	Échirolles
France	Hôpital Raymond Poincaré - Service de Maladies Infectieuses	Garches
France	CHU Grenoble Alpes - Hôpital Michallon - Service de Maladies Infectieuses	La Tronche
France	Hôpital Bicêtre service de rhumatologie	Le Kremlin-Bicêtre
France	Hopital Bicêtre, Service de Maladies Infectieuses et Tropicales	Le Kremlin-Bicêtre
France	CHRU Lille - Service de Rhumatologie	Lille
France	CHR Orléans - Service de Rhumatologie	Orléans
France	GH Diaconesse La Croix St Simon - Service de Rhumatologie	Paris
France	Hôpital Bichat - Service de Maladies Infectieuses	Paris
France	Hôpital Bichat - Service de Rhumatologie	Paris
France	Hôpital Cochin - Service de Maladies Infectieuses	Paris
France	Hôpital Cochin - Service de Rhumatologie	Paris
France	Hôpital Lariboisière Service de Rhumatologie	Paris
France	Hôpital Necker - Service de Maladies Infectieuses	Paris
France	Hôpital Pitié Salpetrière - Service de Maladies Infectieuses	Paris
France	Hôpital Pitié Salpetrière - Service de Rhumatologie	Paris
France	Hôpital Saint Antoine - Service de Rhumatologie	Paris
France	Hôpital Tenon - Service de Maladies Infectieuses	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

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cure at 16 weeks (4 months) after the beginning of the treatment	Cure is defined as absence of clinical signs of joint infection, absence of treatment failure, absence of relapse	16 weeks after Day 0
Secondary	Cure at 24 weeks	Cure is defined as absence of clinical signs of joint infection, absence of treatment failure, absence of relapse	24 weeks after Day 0
Secondary	Treatment failure and relapse and relapse rates	% of relapse at 6,16,24 weeks	6,16,24 weeks after Day 0
Secondary	The patient's quality of life	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.	3,6,16,24 weeks after Day 0
Secondary	The residual joint pain in the affected joint	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".	at 16 and 24 weeks after Day 0
Secondary	hospital length of stay and total treatments costs	To compare cost-effectiveness and cost utility of 3-week vs 6-week antibiotic strategies for patients with arthritis of native joints	through study completion, an average of 3 years
Secondary	joint mobility	joint mobility is assessed by "good mobility, few mobility, no mobility"	at 16 and 24 weeks after Day 0