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Completed

NCT Number: NCT03615781

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

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Key information

Conditions

Arthritis, Septic Arthritis Arthritis, Infectious Infections Joint Diseases Musculoskeletal Diseases

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Geneva University Hospitals

Geneva, 1211, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Aug 6, 2018
Registry last updated
Aug 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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