Short- versus long-duration levofloxacin plus rifampicin for acute staphylococcal prosthetic joint infection managed with implant retention: a randomised clinical trial

Jaime Lora-Tamayo, Gorane Euba, Javier Cobo, Juan Pablo Horcajada, Alex Soriano, Enrique Sandoval, Carles Pigrau, Natividad Benito, Luis Falgueras, Julián Palomino, María Dolores del Toro, Alfredo Jover-Sáenz, José Antonio Iribarren, Mar Sánchez-Somolinos, Antonio Ramos, Marta Fernández-Sampedro, Melchor Riera, Josu Mirena Baraia-Etxaburu, Javier Ariza, Oscar MurilloAlba Ribera, Xavier Cabo, Gema Fresco, Patricia Ruiz-Garbajosa, Joan Leal, Luis Puig, Luisa Sorlí, Laura Morata, Guillem Bori, Juan C. Martínez-Pastor, Dolors Rodríguez-Pardo, Mireia Puig-Asensio, Roger Sordé-Masip, Laura Prats-Gispert, Ferran Pérez-Villar, Mercé García-Gónzalez, Jaime Esteban, Antonio Blanco, Joaquín García-Cañete, Andrés Puente, Gabriel Domecq, Rocío Álvarez, Cecilia Peñas-Espinar, Miguel Ángel Muniain-Ezcurra, Ana Isabel Suárez, Pere Coll, Marcos Jordán, Isabel Mur, Maialen Ibarguren, Gaspar de la Herrán, Isabel Sánchez-Romero, Javier Jiménez-Cristóbal, Elena Múñez-Rubio, Francisco Muntaner, Antonio Ramírez, María Carmen Fariñas, Cristina Campo, Michel Fakkas, Íñigo López-Azkarreta, Sofía Ibarra, Ramón Cisterna, Ana Granados

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25 Citations (Scopus)

Abstract

© 2016 Elsevier B.V. and International Society of Chemotherapy 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.
Original languageEnglish
Pages (from-to)310-316
JournalInternational Journal of Antimicrobial Agents
Volume48
Issue number3
DOIs
Publication statusPublished - 1 Sep 2016

Keywords

  • Biofilm
  • Bone and joint infection
  • Foreign body infection
  • Length of therapy
  • Osteoarticular infection

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