Two Versus Four Weeks of Antibiotic Treatment in Native Joint Arthritis

NCT03615781 | Completed

• 1 other identifier: no. 15-014
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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

Conditions

Arthritis, Septic

Keywords

septic arthritis; surgery; antibiotic duration; remission; sequelae

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Wound redness

  6 months

• Wound discharge

  6 months

• Presence of pus

  6 months

Study Arms (4)

Two week's arm - surgery

EXPERIMENTAL

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

Procedure: Two week's arm - surgery

Four week's arm - surgery

ACTIVE COMPARATOR

The investigators surgically remove the infected implant.

Procedure: Four week's arm - surgery

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.

Drug: Two week's arm - drugs

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).

Drug: Four week's arm - drugs

Interventions

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.

Two week's arm - surgery

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.

Four week's arm - surgery

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.

Two week's arm - drugs

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.

Four week's arm - drugs

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>17 years
• Microbiologically-confirmed septic arthritis
• At least one surgical drainage/lavage

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

Geneva University Hospitals

Geneva, 1211, Switzerland

Location

Related Publications (2)

• 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.

  PMID: 23183231 BACKGROUND

• 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.

  PMID: 30992295 DERIVED

MeSH Terms

Conditions

Arthritis, Infectious

Condition Hierarchy (Ancestors)

Infections; Arthritis; Joint Diseases; Musculoskeletal Diseases

Study Officials

• Ilker Uçkay, MD

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending, Docent Dr. med Ilker Uçkay

Study Record Dates

• First Submitted: January 16, 2017
• First Posted: August 6, 2018
• Study Start: June 1, 2015
• Primary Completion: April 1, 2018
• Study Completion: May 18, 2018
• Last Updated: August 6, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)