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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Two week's arm - surgery | Experimental | The investigators perform a surgical drainage and removal of the infected orthopedic implant. |
|
| Four week's arm - surgery | Active Comparator | The investigators surgically remove the infected implant. |
|
| Two week's arm - drugs | Experimental | 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. |
|
| Four week's arm - drugs | Active Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Two week's arm - surgery | Procedure | The investigators perform a surgical drainage of the infection along with the complete removal of the infected orthopedic implant. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Remission of systemic infection | Measurement of fever. | 6 months |
| Sequels | Patient's remaining gait disorders.
| 6 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ilker Uçkay, MD | University Hospital, Geneva | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geneva University Hospitals | Geneva | 1211 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23183231 | Background | Uckay I, Tovmirzaeva L, Garbino J, Rohner P, Tahintzi P, Suva D, Assal M, Hoffmeyer P, Bernard L, Lew D. Short parenteral antibiotic treatment for adult septic arthritis after successful drainage. Int J Infect Dis. 2013 Mar;17(3):e199-205. doi: 10.1016/j.ijid.2011.12.019. Epub 2012 Nov 22. | |
| 30992295 | Derived |
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| ID | Term |
|---|---|
| D001170 | Arthritis, Infectious |
| ID | Term |
|---|---|
| D007239 | Infections |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Four week's arm - surgery | Procedure | The investigators perform a surgical drainage of the infection along with the complete removal of the infected orthopedic implant. |
|
| Two week's arm - drugs | Drug | 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. |
|
| Four week's arm - drugs | Drug | 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. |
|
| 6 months |
| Presence of pus | Visual examination of the presence of pus coming out the wound | 6 months |
| Gjika E, Beaulieu JY, Vakalopoulos K, Gauthier M, Bouvet C, Gonzalez A, Morello V, Steiger C, Hirsiger S, Lipsky BA, Uckay I. Two weeks versus four weeks of antibiotic therapy after surgical drainage for native joint bacterial arthritis: a prospective, randomised, non-inferiority trial. Ann Rheum Dis. 2019 Aug;78(8):1114-1121. doi: 10.1136/annrheumdis-2019-215116. Epub 2019 Apr 16. |