title: Short- versus long-duration levofloxacin plus rifampicin for acute staphylococcal prosthetic joint infection managed with implant retention: a randomised clinical trial.
abstract: Levofloxacin plus rifampicin (L+R) is the treatment of choice for acute staphylococcal prosthetic joint infection (PJI) managed with debridement and implant retention (DAIR). Long courses have been empirically recommended, but some studies have suggested that shorter treatments could be as effective. Our aim was to prove that a short treatment schedule was non-inferior to the standard long schedule. An open-label, multicentre, randomised clinical trial (RCT) was performed. Patients with an early post-surgical or haematogenous staphylococcal PJI, managed with DAIR and initiated on L+R were randomised to receive 8 weeks of treatment (short schedule) versus a long schedule (3 months or 6 months for hip or knee prostheses, respectively). The primary endpoint was cure rate. From 175 eligible patients, 63 were included (52% women; median age, 72 years): 33 patients (52%) received the long schedule and 30 (48%) received the short schedule. There were no differences between the two groups except for a higher rate of polymicrobial infection in the long-schedule group (27% vs. 7%; P = 0.031). Median follow-up was 540 days. In the intention-to-treat analysis, cure rates were 58% and 73% in patients receiving the long and short schedules, respectively (difference -15.7%, 95% CI -39.2% to 7.8%). Forty-four patients (70%) were evaluable per-protocol: cure rates were 95.0% and 91.7% for the long and short schedules, respectively (difference 3.3%, 95% CI -11.7% to 18.3%). This is the first RCT suggesting that 8 weeks of L+R could be non-inferior to longer standard treatments for acute staphylococcal PJI managed with DAIR.
authors: Unidad de Enfermedades Infecciosas, Hospital Universitario 12 de Octubre, Instituto de Investigación Hospital 12 de Octubre "i+12", Madrid, Spain. Electronic address: jaime@lora-tamayo.es.
authors: Jaime
authors: J
authors: Lora-Tamayo
authors: Servicio de Enfermedades Infecciosas, Hospital Universitario de Bellvitge, Barcelona, Spain.
authors: Gorane
authors: G
authors: Euba
authors: Servicio de Enfermedades Infecciosas, IRYCIS, Hospital Universitario Ramón y Cajal, Madrid, Spain.
authors: Javier
authors: J
authors: Cobo
authors: Servicio de Enfermedades Infecciosas, Hospital del Mar, IMIM, CEXS-UPF, Barcelona, Spain.
authors: Juan Pablo
authors: JP
authors: Horcajada
authors: Servicio de Enfermedades Infecciosas, Hospital Clínic i Provincial, IDIBAPS, Barcelona, Spain.
authors: Alex
authors: A
authors: Soriano
authors: Servicio de Traumatología, Fundación Jiménez Díaz, Madrid, Spain.
authors: Enrique
authors: E
authors: Sandoval
authors: Servicio de Enfermedades Infecciosas, Hospital Universitario Vall d'Hebron, Universitat Autònoma de Barcelona, Barcelona, Spain.
authors: Carles
authors: C
authors: Pigrau
authors: Unidad de Enfermedades Infecciosas, Servicio de Medicina Interna, Hospital de la Santa Creu i Sant Pau, Institut d'Investigació Biomèdica Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain.
authors: Natividad
authors: N
authors: Benito
authors: Servicio de Enfermedades Infecciosas, Corporació Sanitària Parc Taulí, Sabadell, Spain.
authors: Luis
authors: L
authors: Falgueras
authors: Servicio de Enfermedades Infecciosas, Hospital Universitario Virgen del Rocío, Seville, Spain.
authors: Julián
authors: J
authors: Palomino
authors: Unidad Clínica Intercentros de Enfermedades Infecciosas, Microbiología y Medicina Preventiva, Hospitales Universitarios Virgen Macarena y Virgen del Rocío, Seville, Spain.
authors: María Dolores
authors: MD
authors: Del Toro
authors: Unidad Funcional de Infección Nosocomial y Servicio de Medicina Interna, Hospital Universitario Arnau de Vilanova, Lleida, Spain.
authors: Alfredo
authors: A
authors: Jover-Sáenz
authors: Servicio de Enfermedades Infecciosas, Hospital Universitario Donostia, San Sebastián, Spain.
authors: José Antonio
authors: JA
authors: Iribarren
authors: Servicio de Microbiología y Enfermedades Infecciosas, Hospital Universitario Gregorio Marañón, Madrid, Spain.
authors: Mar
authors: M
authors: Sánchez-Somolinos
authors: Unidad de Enfermedades Infecciosas, Servicio de Medicina Interna, Hospital Universitario Puerta de Hierro, Madrid, Spain.
authors: Antonio
authors: A
authors: Ramos
authors: Servicio de Enfermedades Infecciosas, Hospital Universitario Marqués de Valdecilla, Santander, Spain.
authors: Marta
authors: M
authors: Fernández-Sampedro
authors: Unidad de Enfermedades Infecciosas, Servicio de Medicina Interna, Hospital Universitario Son Espases, Palma de Mallorca, Spain.
authors: Melchor
authors: M
authors: Riera
authors: Servicio de Enfermedades Infecciosas, Hospital Universitario de Basurto, Bilbao, Spain.
authors: Josu Mirena
authors: JM
authors: Baraia-Etxaburu
authors: Servicio de Enfermedades Infecciosas, Hospital Universitario de Bellvitge, Barcelona, Spain.
authors: Javier
authors: J
authors: Ariza
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D003646:Debridement; D005260:Female; D006801:Humans; D064704:Levofloxacin / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D010003:Osteoarthritis / Q000188:drug therapy*; D060489:Prosthesis Retention; D016459:Prosthesis-Related Infections / Q000628:therapy*; D012293:Rifampin / Q000008:administration & dosage*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D064704:Levofloxacin; D012293:Rifampin
keywords: Biofilm; Bone and joint infection; Foreign body infection; Length of therapy; Osteoarticular infection