Treatment of the Infections on Osteo-articular Prostheses by 6 Versus 12 Weeks of Antibiotherapy
DATIPO
Multicentric Study, of Non Inferiority, Randomized, Opened, to Evaluate the Two Durations Effectiveness of Antibiotherapy (6 Weeks Versus 12 Weeks) in the Treatment of Osteo-articular Prostheses Infections, With Prosthetic Change (in 1 Time or 2 Long Times) or Not (Articular Washing)
3 other identifiers
interventional
410
1 country
37
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 retention, 1-stage or 2 stage exchange). 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2011
Longer than P75 for phase_3
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 12, 2013
CompletedFirst Posted
Study publicly available on registry
March 21, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 21, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 21, 2017
CompletedDecember 26, 2025
October 1, 2017
5.2 years
March 12, 2013
December 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
occurrence of clinical cure
Percentage of success in 2 years defined by the absence of infection or relapse in the same germ, and the absence of clinical, biological and radiological signs some of infection (pain, fever). This criterion will be estimated beyond the first 6 weeks of treatment antibiotic after the introduction of the treatment and until 2 years after the stop of the treatment.
two years
Secondary Outcomes (1)
microbiological success
2 years
Study Arms (2)
6 weeks
EXPERIMENTALthe duration of antibiotic treatment will be six weeks.
12 weeks
ACTIVE COMPARATORthe duration of antibiotic treatment will be 12 weeks.
Interventions
Used antibiotics already have the AMM in this indication
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (37)
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, 92160, 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, 33076, 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, 71100, 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, 69100, 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, 44093, 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
Related Publications (1)
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.
PMID: 34042388RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 12, 2013
First Posted
March 21, 2013
Study Start
November 1, 2011
Primary Completion
January 21, 2017
Study Completion
January 21, 2017
Last Updated
December 26, 2025
Record last verified: 2017-10