Status:
COMPLETED
Treatment of the Infections on Osteo-articular Prostheses by 6 Versus 12 Weeks of Antibiotherapy
Lead Sponsor:
University Hospital, Tours
Conditions:
Prosthesis-related Infections
Eligibility:
All Genders
18-99 years
Phase:
PHASE3
Brief Summary
The study is a prospective, open randomized, non-inferiority trial with two parallel groups, comparing 6 weeks versus 12 weeks of antibiotic treatment following surgery procedure (debridement and rete...
Detailed Description
Although the infection risk following primary hip and knee arthroplasties is less than 2%, prosthetic joint infections (PJI) have become more frequent due to the increasing number of patients undergoi...
Eligibility Criteria
Inclusion
- Men or women over 18, presenting at least one of the following clinical signs: pain, fever, dent or flow of scar
- Bacterial infection on osteo-articular prosthesis (hip or knee)
- Documented basterial infection
- Surgical care optimized with prothesis change or articular washing
- Infection requiring an antibiotic treatment by parenteral way Intravenous injection or per bone
- Treatment effective antibiotic begun in the most previously 21 days
- Signed consent
Exclusion
- Patient with no proof of osteo-articular infection
- No surgical care
- Patient having more than one prothesis change because of sepsis
- Infection due to mycobactery, fungic infection or brucellienne infection
- Patient with life expectancy supposed lower than 2 years
- Guardianship patient
- Patient included in another study
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 21 2017
Estimated Enrollment :
410 Patients enrolled
Trial Details
Trial ID
NCT01816009
Start Date
November 1 2011
End Date
January 21 2017
Last Update
December 26 2025
Active Locations (37)
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1
Service de chirurgie orthopédique et traumatologique, CHU d'AMIENS
Amiens, France
2
Service des maladies infectieuses et tropicales, CHU d'ANGERS
Angers, France
3
Département de Médecine Interne et Maladies Infectieuses, hôpital privé d'Antony
Antony, France, 92160
4
Service des maladies infectieuses et tropicales, CHU de BESANCON
Besançon, France