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

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ClinicalTrials.gov Identifier: NCT03716921
Recruitment Status : Recruiting
First Posted : October 23, 2018
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Septic Arthritis Other: Short antibiotics treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : February 5, 2019
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Short antibiotics treatment
patients will receive effective antibiotic treatment (IV and oral) for 3 weeks
Other: Short antibiotics treatment
Patients randomized in this arm will pursue antibiotic administration until visit 3 weeks after D0
Other Name: 3-week antibiotic treatment

No Intervention: Long antibiotics treatment
patients will receive effective antibiotic treatment (IV and oral) for 6 weeks according to standard care



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Cure at 24 weeks [ Time Frame: 24 weeks after Day 0 ]
    Cure is defined as absence of clinical signs of joint infection, absence of treatment failure, absence of relapse

  2. Treatment failure and relapse and relapse rates [ Time Frame: 6,16,24 weeks after Day 0 ]
    % of relapse at 6,16,24 weeks

  3. The patient's quality of life [ Time Frame: 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.

  4. The residual joint pain in the affected joint [ Time Frame: 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".

  5. hospital length of stay and total treatments costs [ Time Frame: 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

  6. joint mobility [ Time Frame: at 16 and 24 weeks after Day 0 ]
    joint mobility is assessed by "good mobility, few mobility, no mobility"



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • Soft tissues abscess
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03716921


Contacts
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Contact: Lélia ESCAUT, Dr 01 45 21 74 26 ext +33 lelia.escaut@aphp.Fr

Locations
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Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Lélia ESCAUT, Dr AP-HP Hôpital Bicêtre

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03716921    
Other Study ID Numbers: P170911J
IDRCB ( Other Identifier: 2018 - A02040-55 )
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Septic Arthritis of native joint
short antibiotic treatment
native joint
septic arthritis
Additional relevant MeSH terms:
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Arthritis, Infectious
Arthritis
Joint Diseases
Musculoskeletal Diseases
Infection
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents