Septic ArthritisSHASARNCT03716921
Short 3-week Antibiotic Treatment Versus 6 Weeks in Adults With Septic Arthritis of Native Joint
A study testing Short antibiotics treatment in people with Septic Arthritis, run by Assistance Publique - Hôpitaux de Paris at 31 sites in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Arthritis
- What is being tested?
- Short antibiotics treatment
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 332 participants
- Where
- 31 sitesFrance
- Study dates
- 5 Feb 2019to 25 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Prosthetic joints
- Septic arthritis in the past 12 months
- Osteomyelitis
- Diabetic foot
- Septic choc
- Arthritis due to bacteria resistant to available oral antibiotics
Show all 14Show fewer
- 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
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
France31 sites
Hôpital Avicenne - Service de Rhumatologie
Bobigny, 93000
Hôpital Pellegrin Bordeaux - Service de Rhumatologie
Bordeaux, 33000
Hôpital Ambroise Paré - Service de Rhumatologie
Boulogne-Billancourt, 92104
Hôpital Cavale Blanche - Service de Maladies Infectieuses
Brest, 29600
CHG Pontoise - Centre Hospitalier René Dubos - Service de Rhumatologie
Cergy-Pontoise, 95303
CHU Tours - Hôpital Trousseau - Service de Rhumatologie
Chambray-lès-Tours, 37170
Hôpital Antoine Béclère - Service de Maladies Infectieuses
Clamart, 92140
CHSF - Service de Rhumatologie
Corbeil-Essonnes, 91100
CHU Dijon Bourgogne - Hôpital François Mitterrand -Service de Maladies Infectieuses
Dijon, 21079
CHU Grenoble Alpes - Hôpital Sud - Service de Rhumatologie
Échirolles, 38130
Hôpital Raymond Poincaré - Service de Maladies Infectieuses
Garches, 92380
CHU Grenoble Alpes - Hôpital Michallon - Service de Maladies Infectieuses
La Tronche, 38700
Hopital Bicêtre, Service de Maladies Infectieuses et Tropicales
Le Kremlin-Bicêtre, 94270
Hôpital Bicêtre service de rhumatologie
Le Kremlin-Bicêtre, 94270
CHRU Lille - Service de Rhumatologie
Lille, 59037
CHR Orléans - Service de Rhumatologie
Orléans, 45100
Hôpital Lariboisière Service de Rhumatologie
Paris, 75010
Hôpital Saint Antoine - Service de Rhumatologie
Paris, 75012
Hôpital Pitié Salpetrière - Service de Maladies Infectieuses
Paris, 75013
Hôpital Pitié Salpetrière - Service de Rhumatologie
Paris, 75013
Hôpital Cochin - Service de Maladies Infectieuses
Paris, 75014
Hôpital Cochin - Service de Rhumatologie
Paris, 75014
Hôpital Bichat - Service de Rhumatologie
Paris, 75018
GH Diaconesse La Croix St Simon - Service de Rhumatologie
Paris, 75020
Hôpital Sud Rennes - Service de Rhumatologie
Rennes
CHU Saint Etienne - Hôpital Nord - Service de Maladies Infectieuses
Saint-Priest-en-Jarez, 42270
CHU Saint Etienne - Hôpital Nord - Service de Rhumatologie
Saint-Priest-en-Jarez, 42270
CHRU Strasbourg - Hôpital de Hautepierre - Service de Rhumatologie
Strasbourg, 67200
CHU Tours - Hôpital Bretonneau - Service de Maladies Infectieuses
Tours, 37044
Hôpitaux de Brabois - Service de Maladies Infectieuses
Vandœuvre-lès-Nancy, 54500
Hôpitaux de Brabois - Service de Rhumatologie
Vandœuvre-lès-Nancy, 54500
About this study
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
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.
Read the 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.
- Conditions
- Septic Arthritis
- Being tested
- Short antibiotics treatment
- Keywords
- Septic Arthritis of native joint, short antibiotic treatment, native joint, septic arthritis
- Medical subject headings
- Arthritis, Infectious
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short antibiotics treatmentOther
Also called 3-week antibiotic treatment
Patients randomized in this arm will pursue antibiotic administration until visit 3 weeks after D0
| Study group | Role | What they receive |
|---|---|---|
| Short antibiotics treatment | Experimental | patients will receive effective antibiotic treatment (IV and oral) for 3 weeks Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 16 weeks after Day 0
Secondary outcomes (6)
Cure at 24 weeks
Cure is defined as absence of clinical signs of joint infection, absence of treatment failure, absence of relapse
Measured: 24 weeks after Day 0
Treatment failure and relapse and relapse rates
% of relapse at 6,16,24 weeks
Measured: 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.
Measured: 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".
Measured: 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
Measured: through study completion, an average of 3 years
joint mobility
joint mobility is assessed by "good mobility, few mobility, no mobility"
Measured: at 16 and 24 weeks after Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start5 Feb 2019
- Primary completion4 Aug 2023
- Study completion25 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ArthritisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 332 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lélia ESCAUT, Dr, Principal investigator, AP-HP Hôpital Bicêtre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03716921
- Sponsor's protocol ID
- P170911J
- Other IDs
- IDRCB
- Acronym
- SHASAR
- Status last verified
- Mar 2025
- First submitted
- 10 Oct 2018
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03716921
- Acronym / sponsor ID
- SHASAR / P170911J
- Conditions
- Septic Arthritis
- Keywords
- Septic Arthritis of native joint, short antibiotic treatment, native joint, septic arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 332 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 5 Feb 2019 (actual)
- Primary completion
- 4 Aug 2023 (actual)
- Study completion
- 25 Jan 2024 (actual)
- First posted
- 23 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short antibiotics treatment | Experimental | Other: Short antibiotics treatmentpatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- Prosthetic joints
- Septic arthritis in the past 12 months
- Osteomyelitis
- Diabetic foot
- Septic choc
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Short antibiotics treatmentAlso: 3-week antibiotic treatmentPatients randomized in this arm will pursue antibiotic administration until visit 3 weeks after D0 | Other | Short antibiotics treatment |
Primary outcome
Cure at 16 weeks (4 months) after the beginning of the treatment
Time frame: 16 weeks after Day 0
Cure is defined as absence of clinical signs of joint infection, absence of treatment failure, absence of relapse
6 secondary outcomes
Cure at 24 weeks
Time frame: 24 weeks after Day 0
Treatment failure and relapse and relapse rates
Time frame: 6,16,24 weeks after Day 0
The patient's quality of life
Time frame: 3,6,16,24 weeks after Day 0
The residual joint pain in the affected joint
Time frame: at 16 and 24 weeks after Day 0
hospital length of stay and total treatments costs
Time frame: through study completion, an average of 3 years
joint mobility
Time frame: at 16 and 24 weeks after Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lélia ESCAUT, Dr principal investigator
AP-HP Hôpital Bicêtre
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Short antibiotics treatment in people with Septic Arthritis, run by Assistance Publique - Hôpitaux de Paris at 31 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cure at 16 weeks (4 months) after the beginning of the treatment (time frame: 16 weeks after Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.