Two Versus Four Weeks of Antibiotic Treatment in Native Joint Arthritis

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

Study Overview

• Status: Completed
• Conditions: Arthritis, Septic
• Intervention / Treatment: Procedure: Two week's arm - surgery; Procedure: Four week's arm - surgery; Drug: Two week's arm - drugs; Drug: Four week's arm - drugs

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 Type: Interventional
• Enrollment (Actual): 85
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Geneva, Switzerland, 1211
    • Geneva University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Two week's arm - surgery; The investigators perform a surgical drainage and removal of the infected orthopedic implant.	Procedure: Two week's arm - surgery; The investigators perform a surgical drainage of the infection along with the complete removal of the infected orthopedic implant.
Active Comparator: Four week's arm - surgery; The investigators surgically remove the infected implant.	Procedure: Four week's arm - surgery; The investigators perform a surgical drainage of the infection along with the complete removal of the infected orthopedic implant.
Experimental: 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.	Drug: Two week's arm - drugs; 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.
Active Comparator: 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).	Drug: Four week's arm - drugs; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Geneva
• Investigators: Principal Investigator: Ilker Uçkay, MD, University Hospital, Geneva

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Actual): April 1, 2018
• Study Completion (Actual): May 18, 2018

Study Registration Dates

• First Submitted: January 16, 2017
• First Submitted That Met QC Criteria: July 30, 2018
• First Posted (Actual): August 6, 2018

Study Record Updates

• Last Update Posted (Actual): August 6, 2018
• Last Update Submitted That Met QC Criteria: July 30, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: surgery; remission; septic arthritis; antibiotic duration; sequelae
• Additional Relevant MeSH Terms: Infections; Joint Diseases; Musculoskeletal Diseases; Arthritis; Arthritis, Infectious
• Other Study ID Numbers: no. 15-014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No