Short- versus long-duration levofloxacin plus rifampicin for acute staphylococcal prosthetic joint infection managed with implant retention: a randomised clinical trial
Por:
Lora-Tamayo, J, Euba, G, Cobo, J, Horcajada, JP, Soriano, A, Sandoval, E, Pigrau, C, Benito, N, Falgueras, L, Palomino, J, del Toro, MD, Jover-Saenz, A, Iribarren, JA, Sanchez-Somolinos, M, Ramos, A, Fernandez-Sampedro, M, Riera, M, Baraia-Etxaburu, JM, Ariza, J
Publicada:
1 sep 2016
Resumen:
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. (C) 2016 Elsevier B.V. and International Society of Chemotherapy. All rights reserved.
Filiaciones:
Lora-Tamayo, J:
Hosp Univ 12 Octubre, Inst Invest Hosp 12 Octubre I 12, Unidad Enfermedades Infecciosas, Madrid, Spain
Euba, G:
Hosp Univ Bellvitge, Serv Enfermedades Infecciosas, Barcelona, Spain
Cobo, J:
Hosp Univ Ramon & Cajal, Serv Enfermedades Infecciosas, IRYCIS, Madrid, Spain
Horcajada, JP:
Hosp Mar, Serv Enfermedades Infecciosas, IMIM, CEXS UPF, Barcelona, Spain
Soriano, A:
Hosp Clin Barcelona, Serv Enfermedades Infecciosas, IDIBAPS, Barcelona, Spain
Sandoval, E:
Fdn Jimenez Diaz, Serv Traumatol, Madrid, Spain
Pigrau, C:
Univ Autonoma Barcelona, Hosp Univ Vall dHebron, Serv Enfermedades Infecciosas, Barcelona, Spain
Benito, N:
Univ Autonoma Barcelona, Inst Invest Biomed St Pau, Hosp Santa Creu & St Pau, Unidad Enfermedades Infecciosas,Serv Med Interna, Barcelona, Spain
Falgueras, L:
Corp Sanitaria Parc Tauli, Serv Enfermedades Infecciosas, Sabadell, Spain
Palomino, J:
Hosp Univ Virgen de Rocio, Serv Enfermedades Infecciosas, Seville, Spain
del Toro, MD:
Hospit Virgen de Rocio, Seville, Spain
Hospit Univ Virgen Macarena, Unidad Clin Interctr Enfermedades Infecciosas Mic, Seville, Spain
Jover-Saenz, A:
Hosp Arnau Vilanova, Unidad Func Infecc Nosocomial, Lleida, Spain
Hosp Arnau Vilanova, Serv Med Interna, Lleida, Spain
Iribarren, JA:
Hosp Univ Donostia, Serv Enfermedades Infecciosas, San Sebastian, Spain
Sanchez-Somolinos, M:
Hosp Univ Gregorio Maranon, Serv Microbiol & Enfermedades Infecciosas, Madrid, Spain
Ramos, A:
Hosp Univ Puerta de Hierro, Serv Med Interna, Unidad Enfermedades Infecciosas, Madrid, Spain
Fernandez-Sampedro, M:
Hosp Univ Marques de Valdecilla, Serv Enfermedades Infecciosas, Santander, Spain
Riera, M:
Hosp Univ Son Espases, Serv Med Interna, Unidad Enfermedades Infecciosas, Palma De Mallorca, Spain
Baraia-Etxaburu, JM:
Hosp Univ Basurto, Serv Enfermedades Infecciosas, Bilbao, Spain
Ariza, J:
Hosp Univ Bellvitge, Serv Enfermedades Infecciosas, Barcelona, Spain
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