Two Versus Four Weeks of Antibiotic Treatment in Native Joint Arthritis

University Hospitals (UH)

Status: Completed

Conditions: Arthritis, Septic

Treatments: Drug: Two week's arm - drugs; Procedure: Four week's arm - surgery; Drug: Four week's arm - drugs; Procedure: Two week's arm - surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT03615781

no. 15-014

Details and patient eligibility

About

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

Full 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.

Enrollment: 85 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

85 participants in 4 patient groups

Two week's arm - surgery

Experimental group

Description:

The investigators perform a surgical drainage and removal of the infected orthopedic implant.

Treatment:

Procedure: Two week's arm - surgery

Four week's arm - surgery

Active Comparator group

Description:

The investigators surgically remove the infected implant.

Treatment:

Procedure: Four week's arm - surgery

Two week's arm - drugs

Experimental group

Description:

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.

Treatment:

Drug: Two week's arm - drugs

Four week's arm - drugs

Active Comparator group

Description:

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).

Treatment:

Drug: Four week's arm - drugs