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Antibiotic Therapy for 6 or 12 Weeks for Prosthetic Joint Infection.
Bernard, Louis; Arvieux, Cédric; Brunschweiler, Benoit; Touchais, Sophie; Ansart, Séverine; Bru, Jean-Pierre; Oziol, Eric; Boeri, Cyril; Gras, Guillaume; Druon, Jérôme; Rosset, Philippe; Senneville, Eric; Bentayeb, Houcine; Bouhour, Damien; Le Moal, Gwenaël; Michon, Jocelyn; Aumaître, Hugues; Forestier, Emmanuel; Laffosse, Jean-Michel; Begué, Thierry; Chirouze, Catherine; Dauchy, Fréderic-Antoine; Devaud, Edouard; Martha, Benoît; Burgot, Denis; Boutoille, David; Stindel, Eric; Dinh, Aurélien; Bemer, Pascale; Giraudeau, Bruno; Issartel, Bertrand; Caille, Agnès.
Affiliation
  • Bernard L; From the Division of Infectious Diseases (L.B., G.G.), Orthopedic Unit (J.D., P.R.), and INSERM Centre d'Investigation Clinique 1415 (B.G., A.C.), University Hospital, and University of Tours and University of Nantes, INSERM, SPHERE (Methods in Patient-Centered Outcomes and Health Research) Unité 12
  • Arvieux C; From the Division of Infectious Diseases (L.B., G.G.), Orthopedic Unit (J.D., P.R.), and INSERM Centre d'Investigation Clinique 1415 (B.G., A.C.), University Hospital, and University of Tours and University of Nantes, INSERM, SPHERE (Methods in Patient-Centered Outcomes and Health Research) Unité 12
  • Brunschweiler B; From the Division of Infectious Diseases (L.B., G.G.), Orthopedic Unit (J.D., P.R.), and INSERM Centre d'Investigation Clinique 1415 (B.G., A.C.), University Hospital, and University of Tours and University of Nantes, INSERM, SPHERE (Methods in Patient-Centered Outcomes and Health Research) Unité 12
  • Touchais S; From the Division of Infectious Diseases (L.B., G.G.), Orthopedic Unit (J.D., P.R.), and INSERM Centre d'Investigation Clinique 1415 (B.G., A.C.), University Hospital, and University of Tours and University of Nantes, INSERM, SPHERE (Methods in Patient-Centered Outcomes and Health Research) Unité 12
  • Ansart S; From the Division of Infectious Diseases (L.B., G.G.), Orthopedic Unit (J.D., P.R.), and INSERM Centre d'Investigation Clinique 1415 (B.G., A.C.), University Hospital, and University of Tours and University of Nantes, INSERM, SPHERE (Methods in Patient-Centered Outcomes and Health Research) Unité 12
  • Bru JP; From the Division of Infectious Diseases (L.B., G.G.), Orthopedic Unit (J.D., P.R.), and INSERM Centre d'Investigation Clinique 1415 (B.G., A.C.), University Hospital, and University of Tours and University of Nantes, INSERM, SPHERE (Methods in Patient-Centered Outcomes and Health Research) Unité 12
  • Oziol E; From the Division of Infectious Diseases (L.B., G.G.), Orthopedic Unit (J.D., P.R.), and INSERM Centre d'Investigation Clinique 1415 (B.G., A.C.), University Hospital, and University of Tours and University of Nantes, INSERM, SPHERE (Methods in Patient-Centered Outcomes and Health Research) Unité 12
  • Boeri C; From the Division of Infectious Diseases (L.B., G.G.), Orthopedic Unit (J.D., P.R.), and INSERM Centre d'Investigation Clinique 1415 (B.G., A.C.), University Hospital, and University of Tours and University of Nantes, INSERM, SPHERE (Methods in Patient-Centered Outcomes and Health Research) Unité 12
  • Gras G; From the Division of Infectious Diseases (L.B., G.G.), Orthopedic Unit (J.D., P.R.), and INSERM Centre d'Investigation Clinique 1415 (B.G., A.C.), University Hospital, and University of Tours and University of Nantes, INSERM, SPHERE (Methods in Patient-Centered Outcomes and Health Research) Unité 12
  • Druon J; From the Division of Infectious Diseases (L.B., G.G.), Orthopedic Unit (J.D., P.R.), and INSERM Centre d'Investigation Clinique 1415 (B.G., A.C.), University Hospital, and University of Tours and University of Nantes, INSERM, SPHERE (Methods in Patient-Centered Outcomes and Health Research) Unité 12
  • Rosset P; From the Division of Infectious Diseases (L.B., G.G.), Orthopedic Unit (J.D., P.R.), and INSERM Centre d'Investigation Clinique 1415 (B.G., A.C.), University Hospital, and University of Tours and University of Nantes, INSERM, SPHERE (Methods in Patient-Centered Outcomes and Health Research) Unité 12
  • Senneville E; From the Division of Infectious Diseases (L.B., G.G.), Orthopedic Unit (J.D., P.R.), and INSERM Centre d'Investigation Clinique 1415 (B.G., A.C.), University Hospital, and University of Tours and University of Nantes, INSERM, SPHERE (Methods in Patient-Centered Outcomes and Health Research) Unité 12
  • Bentayeb H; From the Division of Infectious Diseases (L.B., G.G.), Orthopedic Unit (J.D., P.R.), and INSERM Centre d'Investigation Clinique 1415 (B.G., A.C.), University Hospital, and University of Tours and University of Nantes, INSERM, SPHERE (Methods in Patient-Centered Outcomes and Health Research) Unité 12
  • Bouhour D; From the Division of Infectious Diseases (L.B., G.G.), Orthopedic Unit (J.D., P.R.), and INSERM Centre d'Investigation Clinique 1415 (B.G., A.C.), University Hospital, and University of Tours and University of Nantes, INSERM, SPHERE (Methods in Patient-Centered Outcomes and Health Research) Unité 12
  • Le Moal G; From the Division of Infectious Diseases (L.B., G.G.), Orthopedic Unit (J.D., P.R.), and INSERM Centre d'Investigation Clinique 1415 (B.G., A.C.), University Hospital, and University of Tours and University of Nantes, INSERM, SPHERE (Methods in Patient-Centered Outcomes and Health Research) Unité 12
  • Michon J; From the Division of Infectious Diseases (L.B., G.G.), Orthopedic Unit (J.D., P.R.), and INSERM Centre d'Investigation Clinique 1415 (B.G., A.C.), University Hospital, and University of Tours and University of Nantes, INSERM, SPHERE (Methods in Patient-Centered Outcomes and Health Research) Unité 12
  • Aumaître H; From the Division of Infectious Diseases (L.B., G.G.), Orthopedic Unit (J.D., P.R.), and INSERM Centre d'Investigation Clinique 1415 (B.G., A.C.), University Hospital, and University of Tours and University of Nantes, INSERM, SPHERE (Methods in Patient-Centered Outcomes and Health Research) Unité 12
  • Forestier E; From the Division of Infectious Diseases (L.B., G.G.), Orthopedic Unit (J.D., P.R.), and INSERM Centre d'Investigation Clinique 1415 (B.G., A.C.), University Hospital, and University of Tours and University of Nantes, INSERM, SPHERE (Methods in Patient-Centered Outcomes and Health Research) Unité 12
  • Laffosse JM; From the Division of Infectious Diseases (L.B., G.G.), Orthopedic Unit (J.D., P.R.), and INSERM Centre d'Investigation Clinique 1415 (B.G., A.C.), University Hospital, and University of Tours and University of Nantes, INSERM, SPHERE (Methods in Patient-Centered Outcomes and Health Research) Unité 12
  • Begué T; From the Division of Infectious Diseases (L.B., G.G.), Orthopedic Unit (J.D., P.R.), and INSERM Centre d'Investigation Clinique 1415 (B.G., A.C.), University Hospital, and University of Tours and University of Nantes, INSERM, SPHERE (Methods in Patient-Centered Outcomes and Health Research) Unité 12
  • Chirouze C; From the Division of Infectious Diseases (L.B., G.G.), Orthopedic Unit (J.D., P.R.), and INSERM Centre d'Investigation Clinique 1415 (B.G., A.C.), University Hospital, and University of Tours and University of Nantes, INSERM, SPHERE (Methods in Patient-Centered Outcomes and Health Research) Unité 12
  • Dauchy FA; From the Division of Infectious Diseases (L.B., G.G.), Orthopedic Unit (J.D., P.R.), and INSERM Centre d'Investigation Clinique 1415 (B.G., A.C.), University Hospital, and University of Tours and University of Nantes, INSERM, SPHERE (Methods in Patient-Centered Outcomes and Health Research) Unité 12
  • Devaud E; From the Division of Infectious Diseases (L.B., G.G.), Orthopedic Unit (J.D., P.R.), and INSERM Centre d'Investigation Clinique 1415 (B.G., A.C.), University Hospital, and University of Tours and University of Nantes, INSERM, SPHERE (Methods in Patient-Centered Outcomes and Health Research) Unité 12
  • Martha B; From the Division of Infectious Diseases (L.B., G.G.), Orthopedic Unit (J.D., P.R.), and INSERM Centre d'Investigation Clinique 1415 (B.G., A.C.), University Hospital, and University of Tours and University of Nantes, INSERM, SPHERE (Methods in Patient-Centered Outcomes and Health Research) Unité 12
  • Burgot D; From the Division of Infectious Diseases (L.B., G.G.), Orthopedic Unit (J.D., P.R.), and INSERM Centre d'Investigation Clinique 1415 (B.G., A.C.), University Hospital, and University of Tours and University of Nantes, INSERM, SPHERE (Methods in Patient-Centered Outcomes and Health Research) Unité 12
  • Boutoille D; From the Division of Infectious Diseases (L.B., G.G.), Orthopedic Unit (J.D., P.R.), and INSERM Centre d'Investigation Clinique 1415 (B.G., A.C.), University Hospital, and University of Tours and University of Nantes, INSERM, SPHERE (Methods in Patient-Centered Outcomes and Health Research) Unité 12
  • Stindel E; From the Division of Infectious Diseases (L.B., G.G.), Orthopedic Unit (J.D., P.R.), and INSERM Centre d'Investigation Clinique 1415 (B.G., A.C.), University Hospital, and University of Tours and University of Nantes, INSERM, SPHERE (Methods in Patient-Centered Outcomes and Health Research) Unité 12
  • Dinh A; From the Division of Infectious Diseases (L.B., G.G.), Orthopedic Unit (J.D., P.R.), and INSERM Centre d'Investigation Clinique 1415 (B.G., A.C.), University Hospital, and University of Tours and University of Nantes, INSERM, SPHERE (Methods in Patient-Centered Outcomes and Health Research) Unité 12
  • Bemer P; From the Division of Infectious Diseases (L.B., G.G.), Orthopedic Unit (J.D., P.R.), and INSERM Centre d'Investigation Clinique 1415 (B.G., A.C.), University Hospital, and University of Tours and University of Nantes, INSERM, SPHERE (Methods in Patient-Centered Outcomes and Health Research) Unité 12
  • Giraudeau B; From the Division of Infectious Diseases (L.B., G.G.), Orthopedic Unit (J.D., P.R.), and INSERM Centre d'Investigation Clinique 1415 (B.G., A.C.), University Hospital, and University of Tours and University of Nantes, INSERM, SPHERE (Methods in Patient-Centered Outcomes and Health Research) Unité 12
  • Issartel B; From the Division of Infectious Diseases (L.B., G.G.), Orthopedic Unit (J.D., P.R.), and INSERM Centre d'Investigation Clinique 1415 (B.G., A.C.), University Hospital, and University of Tours and University of Nantes, INSERM, SPHERE (Methods in Patient-Centered Outcomes and Health Research) Unité 12
  • Caille A; From the Division of Infectious Diseases (L.B., G.G.), Orthopedic Unit (J.D., P.R.), and INSERM Centre d'Investigation Clinique 1415 (B.G., A.C.), University Hospital, and University of Tours and University of Nantes, INSERM, SPHERE (Methods in Patient-Centered Outcomes and Health Research) Unité 12
N Engl J Med ; 384(21): 1991-2001, 2021 05 27.
Article in En | MEDLINE | ID: mdl-34042388
ABSTRACT

BACKGROUND:

The management of prosthetic joint infection usually consists of a combination of surgery and antimicrobial therapy. The appropriate duration of antimicrobial therapy for this indication remains unclear.

METHODS:

We performed an open-label, randomized, controlled, noninferiority trial to compare 6 weeks with 12 weeks of antibiotic therapy in patients with microbiologically confirmed prosthetic joint infection that had been managed with an appropriate surgical procedure. The primary outcome was persistent infection (defined as the persistence or recurrence of infection with the initial causative bacteria, with an antibiotic susceptibility pattern that was phenotypically indistinguishable from that at enrollment) within 2 years after the completion of antibiotic therapy. Noninferiority of 6 weeks of therapy to 12 weeks of therapy would be shown if the upper boundary of the 95% confidence interval for the absolute between-group difference (the value in the 6-week group minus the value in the 12-week group) in the percentage of patients with persistent infection within 2 years was not greater than 10 percentage points.

RESULTS:

A total of 410 patients from 28 French centers were randomly assigned to receive antibiotic therapy for 6 weeks (205 patients) or for 12 weeks (205 patients). Six patients who withdrew consent were not included in the analysis. In the main analysis, 20 patients who died during follow-up were excluded, and missing outcomes for 6 patients who were lost to follow-up were considered to be persistent infection. Persistent infection occurred in 35 of 193 patients (18.1%) in the 6-week group and in 18 of 191 patients (9.4%) in the 12-week group (risk difference, 8.7 percentage points; 95% confidence interval, 1.8 to 15.6); thus, noninferiority was not shown. Noninferiority was also not shown in the per-protocol and sensitivity analyses. We found no evidence of between-group differences in the percentage of patients with treatment failure due to a new infection, probable treatment failure, or serious adverse events.

CONCLUSIONS:

Among patients with microbiologically confirmed prosthetic joint infections that were managed with standard surgical procedures, antibiotic therapy for 6 weeks was not shown to be noninferior to antibiotic therapy for 12 weeks and resulted in a higher percentage of patients with unfavorable outcomes. (Funded by Programme Hospitalier de Recherche Clinique, French Ministry of Health; DATIPO ClinicalTrials.gov number, NCT01816009.).
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Prosthesis-Related Infections / Hip Prosthesis / Knee Prosthesis / Anti-Bacterial Agents Type of study: Clinical_trials / Guideline Limits: Aged / Female / Humans / Male / Middle aged Language: En Journal: N Engl J Med Year: 2021 Document type: Article
Fulltext
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Prosthesis-Related Infections / Hip Prosthesis / Knee Prosthesis / Anti-Bacterial Agents Type of study: Clinical_trials / Guideline Limits: Aged / Female / Humans / Male / Middle aged Language: En Journal: N Engl J Med Year: 2021 Document type: Article