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| ID | Type | Description | Link |
|---|---|---|---|
| IDRCB | Other Identifier | 2018 - A02040-55 |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Short antibiotics treatment | Experimental | patients will receive effective antibiotic treatment (IV and oral) for 3 weeks |
|
| Long antibiotics treatment | No Intervention | patients will receive effective antibiotic treatment (IV and oral) for 6 weeks according to standard care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Short antibiotics treatment | Other | Patients randomized in this arm will pursue antibiotic administration until visit 3 weeks after D0 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Treatment failure and relapse and relapse rates |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lélia ESCAUT, Dr | AP-HP Hôpital Bicêtre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Avicenne - Service de Rhumatologie | Bobigny | 93000 | France | |||
| Hôpital Pellegrin Bordeaux - Service de Rhumatologie |
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% of relapse at 6,16,24 weeks
| 6,16,24 weeks after Day 0 |
| 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 |
| 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 |
| 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 |
| joint mobility | joint mobility is assessed by "good mobility, few mobility, no mobility" | at 16 and 24 weeks after Day 0 |
| Bordeaux |
| 33000 |
| France |
| Hôpital Ambroise Paré - Service de Rhumatologie | Boulogne-Billancourt | 92104 | France |
| Hôpital Cavale Blanche - Service de Maladies Infectieuses | Brest | 29600 | France |
| CHG Pontoise - Centre Hospitalier René Dubos - Service de Rhumatologie | Cergy-Pontoise | 95303 | France |
| CHU Tours - Hôpital Trousseau - Service de Rhumatologie | Chambray-lès-Tours | 37170 | France |
| Hôpital Antoine Béclère - Service de Maladies Infectieuses | Clamart | 92140 | France |
| CHSF - Service de Rhumatologie | Corbeil-Essonnes | 91100 | France |
| CHU Dijon Bourgogne - Hôpital François Mitterrand -Service de Maladies Infectieuses | Dijon | 21079 | France |
| CHU Grenoble Alpes - Hôpital Sud - Service de Rhumatologie | Échirolles | 38130 | France |
| Hôpital Raymond Poincaré - Service de Maladies Infectieuses | Garches | 92380 | France |
| CHU Grenoble Alpes - Hôpital Michallon - Service de Maladies Infectieuses | La Tronche | 38700 | France |
| Hopital Bicêtre, Service de Maladies Infectieuses et Tropicales | Le Kremlin-Bicêtre | 94270 | France |
| Hôpital Bicêtre service de rhumatologie | Le Kremlin-Bicêtre | 94270 | France |
| CHRU Lille - Service de Rhumatologie | Lille | 59037 | France |
| CHR Orléans - Service de Rhumatologie | Orléans | 45100 | France |
| Hôpital Lariboisière Service de Rhumatologie | Paris | 75010 | France |
| Hôpital Saint Antoine - Service de Rhumatologie | Paris | 75012 | France |
| Hôpital Pitié Salpetrière - Service de Maladies Infectieuses | Paris | 75013 | France |
| Hôpital Pitié Salpetrière - Service de Rhumatologie | Paris | 75013 | France |
| Hôpital Cochin - Service de Maladies Infectieuses | Paris | 75014 | France |
| Hôpital Cochin - Service de Rhumatologie | Paris | 75014 | France |
| Hôpital Bichat - Service de Rhumatologie | Paris | 75018 | France |
| GH Diaconesse La Croix St Simon - Service de Rhumatologie | Paris | 75020 | France |
| Hôpital Sud Rennes - Service de Rhumatologie | Rennes | France |
| CHU Saint Etienne - Hôpital Nord - Service de Maladies Infectieuses | Saint-Priest-en-Jarez | 42270 | France |
| CHU Saint Etienne - Hôpital Nord - Service de Rhumatologie | Saint-Priest-en-Jarez | 42270 | France |
| CHRU Strasbourg - Hôpital de Hautepierre - Service de Rhumatologie | Strasbourg | 67200 | France |
| CHU Tours - Hôpital Bretonneau - Service de Maladies Infectieuses | Tours | 37044 | France |
| Hôpitaux de Brabois - Service de Maladies Infectieuses | Vandœuvre-lès-Nancy | 54500 | France |
| Hôpitaux de Brabois - Service de Rhumatologie | Vandœuvre-lès-Nancy | 54500 | France |
| ID | Term |
|---|---|
| D001170 | Arthritis, Infectious |
| ID | Term |
|---|---|
| D007239 | Infections |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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