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OpenTrials
Completed

NCT Number: NCT03602209

Short vs. Long Antibiotic Treatment of Implant-free Osteoarticular Infections

The investigators tested the working hypothesis if 4 weeks of systemic antibiotic treatment in implant-related orthopaedic infections is non-inferior to 6 weeks after complete removal of the infected implant. Randomization 1:1.

The study is completed. It halted prematurely and will not resume; participants are no longer being examined or receiving intervention.

Completed

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Key information

Conditions

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

Former description of the study (now completed)

Osteoarticular infections related to orthopaedic implants are associated with substantial morbidity, prolongation of hospital stay, and additional costs. Due to the increasing number of patients with orthopaedic implants in Switzerland, similar to the rest of Europe and elsewhere, the number of infections is expected to increase. While the surgical treatment of these infections has been well studied, the ideal duration of antibiotic therapy after removal (explantation) of the infected implant remains unknown. For almost 40 years, the recommended total duration of post-explantation antibiotic therapy has been 6 weeks. This recommendation is based on expert's personal experience rather than on prospective randomized studies. Shorter treatment would decrease antibiotic-related adverse events and costs hospital stay for patients awaiting an eventual reinsertion of a new implant. If physicians and surgeon prescribe antibiotics for 6 weeks, this duration should be at least supported by evidence.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients (≥17 years old)
  • Total removal of the implant

Exclusion criteria

  • Primary native joint septic arthritis;
  • Co-trimoxazole prophylaxis because of immunosuppression;
  • Left-side endocarditis;
  • Persistent implant material in the infected area.
  • Infections with tuberculosis; mycobacteria; fungi; brucellosis; borreliosis; nocardiosis; and mycoplasmal osteosynthesis infections

Treatment and study plan

Removal of infected implant

Procedure

Antibiotic durations

Drug

Primary outcomes

  1. Remission of infection

    Time frame: 12 months

    Clinical evaluation

  2. Adverse events

    Time frame: 12 months

    Clinical adverse events

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jul 26, 2018
Registry last updated
Aug 1, 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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