Clinical trial NCT03615781: Two Versus Four Weeks of Antibiotic Treatment in Native Joint Arthritis
Official title: Two Versus Four Weeks of Antibiotic Treatment in Native Joint Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthritis, Septic
Keywords: septic arthritis
surgery
antibiotic duration
remission
sequelae
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2018-08-06
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. Age \>17 years
2. Microbiologically-confirmed septic arthritis
3. At least one surgical drainage/lavage

Exclusion Criteria:

1. Presence of osteosynthesis material in the vicinity of the articulation
2. Presence of a concomitant infection needing more than 2 week's of antibiotic therapy
3. More than 3 surgical drainages
4. Life expectancy less than 6 months
5. Chronic osteomyelitis in vicinity of the arthritis

Primary outcomes:
measure: Clinical Remission of systemic infection
timeFrame: 6 months
measure: Sequels
timeFrame: 6 months
Secondary outcomes:
measure: Wound redness
timeFrame: 6 months
measure: Wound discharge
timeFrame: 6 months
measure: Presence of pus
timeFrame: 6 months
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Geneva University Hospitals
Study officials:
affiliation: University Hospital, Geneva
name: Ilker Uçkay, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.