Two Versus Four Weeks of Antibiotic Treatment in Native Joint Arthritis

Not Applicable

Completed

• Conditions: Arthritis, Septic
• Interventions: Procedure: Two week's arm - surgery; Procedure: Four week's arm - surgery; Drug: Two week's arm - drugs; Drug: Four week's arm - drugs

• Registration Number: NCT03615781
• Lead Sponsor: University Hospital, Geneva

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.

Study Timeline

• Study Start: 2015-06-01
• Study First Submitted: 2017-01-16
• Primary Completion: 2018-04-01
• Study Completion: 2018-05-18
• Status Verified: 2018-07
• Study First Submitted QC: 2018-07-30
• Last Update Submitted: 2018-07-30
• Study First Posted: 2018-08-06
• Last Update Posted: 2018-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Two week's arm - surgery	Two week's arm - surgery	The investigators perform a surgical drainage and removal of the infected orthopedic implant.
Four week's arm - surgery	Four week's arm - surgery	The investigators surgically remove the infected implant.
Two week's arm - drugs	Two week's arm - drugs	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	Four week's arm - drugs	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).

Primary Outcome Measures

Name	Time	Method
Clinical Remission of systemic infection	6 months	Measurement of fever.
Sequels	6 months	Patient's remaining gait disorders.; * range of movement in adjacent joints of former infection; * questionnaire regarding persistant pain and handicaps (open wording)

Secondary Outcome Measures

Name	Time	Method
Presence of pus	6 months	Visual examination of the presence of pus coming out the wound
Wound redness	6 months	Visual examination of the presence of wound redness.
Wound discharge	6 months	Visual examination of the presence of wound discharge

Trial Locations

Locations (1)

Geneva University Hospitals; 🇨🇭 Geneva, Switzerland