Two Versus Four Weeks of Antibiotic Treatment in Native Joint Arthritis

Study Overview
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Brief Summary
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The optimal duration of systemic antibiotic administration for native joint septic arthritis is unknown. The investigators perform a randomized study allowing up to 3 surgical lavages and allocating patients into a two-week's and a four week's randomization arm

Detailed Description
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The optimal duration of systemic antibiotic administration for native joint septic arthritis is unknown. The investigators perform a randomized study allocating patients into a two-week's and a four week's randomization arm. The adult patients are hospitalized for septic arthritis. A computer program randomizes 1:1 between a two week's and a four week's arm of targeted antibiotic treatment of which at least the first week is intravenously. The randomization may occur until Day 5 of admission. Up to three surgical interventions are allowed. The investigators allow the inclusion of all bacterial arthritis and all joints.

Official Title
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Two Versus Four Weeks of Antibiotic Treatment in Native Joint Arthritis

Conditions
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Arthritis, Septic

Intervention / Treatment
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* Procedure: Two week's arm - surgery
* Procedure: Four week's arm - surgery
* Drug: Two week's arm - drugs
* Drug: Four week's arm - drugs


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >17 years Microbiologically-confirmed septic arthritis At least one surgical drainage/lavage Exclusion Criteria: Presence of osteosynthesis material in the vicinity of the articulation Presence of a concomitant infection needing more than 2 week's of antibiotic therapy More than 3 surgical drainages Life expectancy less than 6 months Chronic osteomyelitis in vicinity of the arthritis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Two week's arm - surgery<br>The investigators perform a surgical drainage and removal of the infected orthopedic implant. | Procedure: Two week's arm - surgery<br>* The investigators perform a surgical drainage of the infection along with the complete removal of the infected orthopedic implant.<br>|
| Active Comparator: Four week's arm - surgery<br>The investigators surgically remove the infected implant. | Procedure: Four week's arm - surgery<br>* The investigators perform a surgical drainage of the infection along with the complete removal of the infected orthopedic implant.<br>|
| Experimental: Two week's arm - drugs<br>The investigators perform a surgical drainage and removal of the infected orthopedic implant. They start an empirical antibiotic treatment based on patient's history and co-morbidities, such as vancomycin or amoxicillin/clavulanic acid. The adapt later on the targeted antibiotic therapy according to the causative pathogens and their antibiotic susceptibility testing. | Drug: Two week's arm - drugs<br>* After the surgical implant removal, the investigators prescribe a total of 2 weeks of systemic targeted antibiotic therapy against the causative pathogen(s), of which one week is recommended to be intravenously.<br>|
| Active Comparator: Four week's arm - drugs<br>The investigators surgically remove the infected implant and all soft tissue infection. Instead of a total of 2 week's of antibiotic therapy, they administer a total of 4 weeks of systemic antibiotic therapy targeted to the pathogen(s). | Drug: Four week's arm - drugs<br>* After the surgical implant removal, the investigators prescribe a total of 4 weeks of systemic targeted antibiotic therapy against the causative pathogen(s), of which one week is recommended to be intravenously.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Remission of systemic infection | Measurement of fever. | 6 months | 
| Sequels | Patient's remaining gait disorders. range of movement in adjacent joints of former infection questionnaire regarding persistant pain and handicaps (open wording) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound redness | Visual examination of the presence of wound redness. | 6 months | 
| Wound discharge | Visual examination of the presence of wound discharge | 6 months | 
| Presence of pus | Visual examination of the presence of pus coming out the wound | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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septic arthritis, surgery, antibiotic duration, remission, sequelae