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

NCT03716921 | Completed

• 2 other identifiers: P170911JIDRCB
• Study Type: interventional
• Target: 332
• Locations: 1 country
• Sites: 31

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.

Conditions

Septic Arthritis

Keywords

Septic Arthritis of native joint; short antibiotic treatment; native joint; septic arthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Cure at 24 weeks

  24 weeks after Day 0

• Treatment failure and relapse and relapse rates

  6,16,24 weeks after Day 0

• The patient's quality of life

  3,6,16,24 weeks after Day 0

• The residual joint pain in the affected joint

  at 16 and 24 weeks after Day 0

• hospital length of stay and total treatments costs

  through study completion, an average of 3 years

Study Arms (2)

Short antibiotics treatment

EXPERIMENTAL

patients will receive effective antibiotic treatment (IV and oral) for 3 weeks

Other: Short antibiotics treatment

Long antibiotics treatment

NO INTERVENTION

patients will receive effective antibiotic treatment (IV and oral) for 6 weeks according to standard care

Interventions

Short antibiotics treatment OTHER

Patients randomized in this arm will pursue antibiotic administration until visit 3 weeks after D0

Also known as: 3-week antibiotic treatment

Short antibiotics treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (31)

Hôpital Avicenne - Service de Rhumatologie

Bobigny, 93000, France

Location

Hôpital Pellegrin Bordeaux - Service de Rhumatologie

Bordeaux, 33000, France

Location

Hôpital Ambroise Paré - Service de Rhumatologie

Boulogne-Billancourt, 92104, France

Location

Hôpital Cavale Blanche - Service de Maladies Infectieuses

Brest, 29600, France

Location

CHG Pontoise - Centre Hospitalier René Dubos - Service de Rhumatologie

Cergy-Pontoise, 95303, France

Location

CHU Tours - Hôpital Trousseau - Service de Rhumatologie

Chambray-lès-Tours, 37170, France

Location

Hôpital Antoine Béclère - Service de Maladies Infectieuses

Clamart, 92140, France

Location

CHSF - Service de Rhumatologie

Corbeil-Essonnes, 91100, France

Location

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

Dijon, 21079, France

Location

CHU Grenoble Alpes - Hôpital Sud - Service de Rhumatologie

Échirolles, 38130, France

Location

Hôpital Raymond Poincaré - Service de Maladies Infectieuses

Garches, 92380, France

Location

CHU Grenoble Alpes - Hôpital Michallon - Service de Maladies Infectieuses

La Tronche, 38700, France

Location

Hopital Bicêtre, Service de Maladies Infectieuses et Tropicales

Le Kremlin-Bicêtre, 94270, France

Location

Hôpital Bicêtre service de rhumatologie

Le Kremlin-Bicêtre, 94270, France

Location

CHRU Lille - Service de Rhumatologie

Lille, 59037, France

Location

CHR Orléans - Service de Rhumatologie

Orléans, 45100, France

Location

Hôpital Lariboisière Service de Rhumatologie

Paris, 75010, France

Location

Hôpital Saint Antoine - Service de Rhumatologie

Paris, 75012, France

Location

Hôpital Pitié Salpetrière - Service de Maladies Infectieuses

Paris, 75013, France

Location

Hôpital Pitié Salpetrière - Service de Rhumatologie

Paris, 75013, France

Location

Hôpital Cochin - Service de Maladies Infectieuses

Paris, 75014, France

Location

Hôpital Cochin - Service de Rhumatologie

Paris, 75014, France

Location

Hôpital Bichat - Service de Rhumatologie

Paris, 75018, France

Location

GH Diaconesse La Croix St Simon - Service de Rhumatologie

Paris, 75020, France

Location

Hôpital Sud Rennes - Service de Rhumatologie

Rennes, France

Location

CHU Saint Etienne - Hôpital Nord - Service de Maladies Infectieuses

Saint-Priest-en-Jarez, 42270, France

Location

CHU Saint Etienne - Hôpital Nord - Service de Rhumatologie

Saint-Priest-en-Jarez, 42270, France

Location

CHRU Strasbourg - Hôpital de Hautepierre - Service de Rhumatologie

Strasbourg, 67200, France

Location

CHU Tours - Hôpital Bretonneau - Service de Maladies Infectieuses

Tours, 37044, France

Location

Hôpitaux de Brabois - Service de Maladies Infectieuses

Vandœuvre-lès-Nancy, 54500, France

Location

Hôpitaux de Brabois - Service de Rhumatologie

Vandœuvre-lès-Nancy, 54500, France

Location

MeSH Terms

Conditions

Arthritis, Infectious

Condition Hierarchy (Ancestors)

Infections; Arthritis; Joint Diseases; Musculoskeletal Diseases

Study Officials

• Lélia ESCAUT, Dr

  AP-HP Hôpital Bicêtre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2018
• First Posted: October 23, 2018
• Study Start: February 5, 2019
• Primary Completion: August 4, 2023
• Study Completion: January 25, 2024
• Last Updated: April 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (31)