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Two Versus Four Weeks of Antibiotic Treatment in Native Joint Arthritis

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ClinicalTrials.gov Identifier: NCT03615781
Recruitment Status : Completed
First Posted : August 6, 2018
Last Update Posted : August 6, 2018
Sponsor:
Information provided by (Responsible Party):
Ilker Uckay, 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

Condition or disease Intervention/treatment Phase
Arthritis, Septic Procedure: Two week's arm - surgery Procedure: Four week's arm - surgery Drug: Two week's arm - drugs Drug: Four week's arm - drugs Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Two Versus Four Weeks of Antibiotic Treatment in Native Joint Arthritis
Actual Study Start Date : June 1, 2015
Actual Primary Completion Date : April 1, 2018
Actual Study Completion Date : May 18, 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Clinical Remission of systemic infection [ Time Frame: 6 months ]
    Measurement of fever.

  2. Sequels [ Time Frame: 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 :
  1. Wound redness [ Time Frame: 6 months ]
    Visual examination of the presence of wound redness.

  2. Wound discharge [ Time Frame: 6 months ]
    Visual examination of the presence of wound discharge

  3. Presence of pus [ Time Frame: 6 months ]
    Visual examination of the presence of pus coming out the wound



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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03615781


Locations
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Switzerland
Geneva University Hospitals
Geneva, Switzerland, 1211
Sponsors and Collaborators
University Hospital, Geneva
Investigators
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Principal Investigator: Ilker Uçkay, MD University Hospital, Geneva

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ilker Uckay, Attending, Docent Dr. med Ilker Uçkay, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT03615781     History of Changes
Other Study ID Numbers: no. 15-014
First Posted: August 6, 2018    Key Record Dates
Last Update Posted: August 6, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ilker Uckay, University Hospital, Geneva:
septic arthritis
surgery
antibiotic duration
remission
sequelae
Additional relevant MeSH terms:
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Arthritis, Infectious
Arthritis
Joint Diseases
Musculoskeletal Diseases
Infection
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents