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

Implant Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03602209
• Other study ID #: No. 14-198
• Status: Completed
• Phase: N/A
• Start date: March 1, 2015
• Est. completion date: May 18, 2018

Study information

• Verified date: July 2018
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 18, 2018
• Est. primary completion date: February 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Implant Infection
• Infection

Intervention

Procedure:
• Removal of infected implant

Drug:
• Antibiotic durations

Locations

Country	Name	City	State
Switzerland	Geneva University Hospitals	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

Al-Mayahi M, Betz M, Müller DA, Stern R, Tahintzi P, Bernard L, Hoffmeyer P, Suvà D, Uçkay I. Remission rate of implant-related infections following revision surgery after fractures. Int Orthop. 2013 Nov;37(11):2253-8. doi: 10.1007/s00264-013-2092-1. Epub 2013 Sep 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Remission of infection	Clinical evaluation	12 months
Primary	Adverse events	Clinical adverse events	12 months