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Two Versus Four Weeks of Antibiotic Treatment in Native Joint Arthritis

Primary Purpose

Arthritis, Septic

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Two week's arm - surgery
Four week's arm - surgery
Two week's arm - drugs
Four week's arm - drugs
Sponsored by
University Hospital, Geneva
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis, Septic focused on measuring septic arthritis, surgery, antibiotic duration, remission, sequelae

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Geneva University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Two week's arm - surgery

Four week's arm - surgery

Two week's arm - drugs

Four week's arm - drugs

Arm Description

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

The investigators surgically remove the infected implant.

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.

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).

Outcomes

Primary Outcome Measures

Clinical Remission of systemic infection
Measurement of fever.
Sequels
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

Wound redness
Visual examination of the presence of wound redness.
Wound discharge
Visual examination of the presence of wound discharge
Presence of pus
Visual examination of the presence of pus coming out the wound

Full Information

First Posted
January 16, 2017
Last Updated
July 30, 2018
Sponsor
University Hospital, Geneva
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1. Study Identification

Unique Protocol Identification Number
NCT03615781
Brief Title
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

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
June 1, 2015 (Actual)
Primary Completion Date
April 1, 2018 (Actual)
Study Completion Date
May 18, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Geneva

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Septic
Keywords
septic arthritis, surgery, antibiotic duration, remission, sequelae

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Two week's arm - surgery
Arm Type
Experimental
Arm Description
The investigators perform a surgical drainage and removal of the infected orthopedic implant.
Arm Title
Four week's arm - surgery
Arm Type
Active Comparator
Arm Description
The investigators surgically remove the infected implant.
Arm Title
Two week's arm - drugs
Arm Type
Experimental
Arm 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.
Arm Title
Four week's arm - drugs
Arm Type
Active Comparator
Arm 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).
Intervention Type
Procedure
Intervention Name(s)
Two week's arm - surgery
Intervention Description
The investigators perform a surgical drainage of the infection along with the complete removal of the infected orthopedic implant.
Intervention Type
Procedure
Intervention Name(s)
Four week's arm - surgery
Intervention Description
The investigators perform a surgical drainage of the infection along with the complete removal of the infected orthopedic implant.
Intervention Type
Drug
Intervention Name(s)
Two week's arm - drugs
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Four week's arm - drugs
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinical Remission of systemic infection
Description
Measurement of fever.
Time Frame
6 months
Title
Sequels
Description
Patient's remaining gait disorders. range of movement in adjacent joints of former infection questionnaire regarding persistant pain and handicaps (open wording)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Wound redness
Description
Visual examination of the presence of wound redness.
Time Frame
6 months
Title
Wound discharge
Description
Visual examination of the presence of wound discharge
Time Frame
6 months
Title
Presence of pus
Description
Visual examination of the presence of pus coming out the wound
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age >17 years Microbiologically-confirmed septic arthritis At least one surgical drainage/lavage Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ilker Uçkay, MD
Organizational Affiliation
University Hospital, Geneva
Official's Role
Principal Investigator
Facility Information:
Facility Name
Geneva University Hospitals
City
Geneva
ZIP/Postal Code
1211
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23183231
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.
Results Reference
background
PubMed Identifier
30992295
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.
Results Reference
derived

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Two Versus Four Weeks of Antibiotic Treatment in Native Joint Arthritis

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