Treatment of the Infections on Osteo-articular Prostheses by 6 Versus 12 Weeks of Antibiotherapy
NCT ID: NCT01816009
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
410 participants
INTERVENTIONAL
2011-11-30
2017-01-21
Brief Summary
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The duration of the treatment antibiotic of prosthetic joint infections is only based on experts' opinion ; this one varies from 6 weeks to several months according to the customs of the influencer.
The principal aim of this study is to explore the efficacy and safety of 6 weeks versus 12 weeks antibiotic therapy duration, both associated with surgical procedure (debridement and retention of implant, one-stage or two stages exchange), in PJI treatment.
The study concerns 410 men or women of more than 18 years include in 34 centres in France.
The duration of the study is of 4 years.
Detailed Description
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Sometimes, excessive antibiotic treatment durations are performed because recommendations are not evidence-based sensu strictu and only based on experts' opinion. Short therapy should be benefit to ecologic and economic impact.
While the usual treatment is by the parenteral route for the first 2-4 weeks, this attitude is not evidence-based either. Up to one-third of patients with PJI may experience antibiotic-related or catheter-related problems during parenteral treatment. The one-stage and two-stage exchange of the infected implant has rather comparable success rate in the surgical management of the PJI (about 90%). Recent no-randomized studies indicate that short antibiotic therapy (6 weeks) seems to be efficient.
Our proposal study is to explore the efficacy and safety of 6 weeks in the treatment of PJI, after a surgical procedure.
The principal aim of this study is to explore the efficacy and safety of 6 weeks versus 12 weeks antibiotic therapy duration, both associated with surgical procedure (debridement and retention of implant, one-stage or two stages exchange), in PJI treatment.
Treatments antibiotics are chosen according to the germ and according to the consensual recommendations. Used antibiotics already have the AMM in this indication.
Eligible patients have at least one symptom relating to the PJI (such pain, sinus tract, inflammatory surgical scar…) and microbiological documentation of PJI.The primary endpoint is the occurrence of clinical cure at month 24. Secondary endpoints are (i) adequate clinical and biological response at months 6 and 12, (ii) incidence of adverse events in the two groups, (iii) oral and/or intravenous antibiotic therapy efficacy.
Randomization is stratified by the anatomical location of the infected joint (hip or knee) and surgical procedure (debridement and retention, 1-stage or 2 stage exchange).
The follow-up consists on periodic clinical examinations, anamnesis and occasionally laboratory or radiological controls.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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6 weeks
the duration of antibiotic treatment will be six weeks.
duration of antibiotic treatment
Used antibiotics already have the AMM in this indication
12 weeks
the duration of antibiotic treatment will be 12 weeks.
duration of antibiotic treatment
Used antibiotics already have the AMM in this indication
Interventions
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duration of antibiotic treatment
Used antibiotics already have the AMM in this indication
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
99 Years
ALL
No
Sponsors
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University Hospital, Tours
OTHER
Responsible Party
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Locations
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Service de chirurgie orthopédique et traumatologique, CHU d'AMIENS
Amiens, , France
Service des maladies infectieuses et tropicales, CHU d'ANGERS
Angers, , France
Département de Médecine Interne et Maladies Infectieuses, hôpital privé d'Antony
Antony, , France
Service des maladies infectieuses et tropicales, CHU de BESANCON
Besançon, , France
Service de médecine interne, CH de BEZIERS
Béziers, , France
Service de chirurgie orthopédique et traumatologique, Polyclinique de BLOIS
Blois, , France
Service de Maladies Infectieuses et de Médecine Tropicale, Hôpital Pellegrin, CHU de Bordeaux
Bordeaux, , France
Service de chirurgie orthopédique et traumatologique, CH de BOURG EN BRESSE
Bourg-en-Bresse, , France
Service de Maladies Infectieuses, CH de BOURG EN BRESSE
Bourg-en-Bresse, , France
Service de médecine interne et de maladies infectieuses, CHU de BREST
Brest, , France
Service des maladies infectieuses et tropicales, CHU de CAEN
Caen, , France
Service des maladies infectieuses et tropicales - médecine interne, CH de CHAMBERY
Chambéry, , France
Service de médecine interne, rhumatologie, Centre Hospitalier Chalon sur Saône William Morey
Châlon Sur Saone, , France
Service de Chirurgie Orthopédique et Traumatologique, APHP Hôpital Antoine Béclère
Clamart, , France
Service de Médecine Interne et Immunologie Clinique, APHP Hôpital Antoine Béclère
Clamart, , France
Service des maladies infectieuses et tropicales, CH de CLERMONT-FERRAND
Clermont-Ferrand, , France
Centre de chirurgie orthopédique et de la main, CHRU de STRASBOURG
Illkirch-Graffenstaden, , France
Unité de Traumatologie -Orthopédie septique, CHRU de LILLE
Lille, , France
Service de Maladies Infectieuses, CHU de LIMOGES
Limoges, , France
Centre de vaccinations internationales et de médecine des voyages du Tonkin
Lyon, , France
Service des Maladies Infectieuses et tropicales, CHU de MONTPELLIER
Montpellier, , France
Service des Maladies Infectieuses et tropicales, CHU de NANCY
Nancy, , France
Service des maladies infectieuses et tropicales Hôtel-Dieu, CHU de Nantes
Nantes, , France
Service de Chirurgie orthopédique Hôpital Lariboisière
Paris, , France
Service des maladies infectieuses et tropicales CH Saint-Jean
Perpignan, , France
Service de médecine interne, maladies infections et tropicales, CHU de POITIERS
Poitiers, , France
Service de médecine interne, PONTOISE
Pontoise, , France
Service des maldies infectieuses, CH d'ANNECY
Pringy, , France
Service de Maladies Infectieuses, CHU de REIMS
Reims, , France
Service des Maladies Infectieuses, CHU de RENNES
Rennes, , France
Service de pneumologie - maladies infectieuses et tropicales, CH de ST QUENTIN
Saint-Quentin, , France
Service d'infectiologie, CH de TOULON
Toulon, , France
Service de Chirurgie Orthopédique et Traumatologique
Toulouse, , France
Service des maladies infectieuses CH Gustave Dron
Tourcoing, , France
Service de Chirurgie Orthopédique et traumatologie, hôpital Trousseau
Tours, , France
Service de Médecine Interne et de Maladies Infectieuses, CHRU de TOURS
Tours, , France
Service de chirurgie orthopédique, CH de VERSAILLES
Versailles, , France
Countries
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References
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Bernard L, Arvieux C, Brunschweiler B, Touchais S, Ansart S, Bru JP, Oziol E, Boeri C, Gras G, Druon J, Rosset P, Senneville E, Bentayeb H, Bouhour D, Le Moal G, Michon J, Aumaitre H, Forestier E, Laffosse JM, Begue T, Chirouze C, Dauchy FA, Devaud E, Martha B, Burgot D, Boutoille D, Stindel E, Dinh A, Bemer P, Giraudeau B, Issartel B, Caille A. Antibiotic Therapy for 6 or 12 Weeks for Prosthetic Joint Infection. N Engl J Med. 2021 May 27;384(21):1991-2001. doi: 10.1056/NEJMoa2020198.
Other Identifiers
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2010-021242-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
A101472-32
Identifier Type: OTHER
Identifier Source: secondary_id
PHRN09 - LB / DATIPO
Identifier Type: -
Identifier Source: org_study_id