TY - JOUR
T1 - Short- versus long-duration levofloxacin plus rifampicin for acute staphylococcal prosthetic joint infection managed with implant retention: a randomised clinical trial
AU - Lora-Tamayo, Jaime
AU - Euba, Gorane
AU - Cobo, Javier
AU - Horcajada, Juan Pablo
AU - Soriano, Alex
AU - Sandoval, Enrique
AU - Pigrau, Carles
AU - Benito, Natividad
AU - Falgueras, Luis
AU - Palomino, Julián
AU - del Toro, María Dolores
AU - Jover-Sáenz, Alfredo
AU - Iribarren, José Antonio
AU - Sánchez-Somolinos, Mar
AU - Ramos, Antonio
AU - Fernández-Sampedro, Marta
AU - Riera, Melchor
AU - Baraia-Etxaburu, Josu Mirena
AU - Ariza, Javier
AU - Murillo, Oscar
AU - Ribera, Alba
AU - Cabo, Xavier
AU - Fresco, Gema
AU - Ruiz-Garbajosa, Patricia
AU - Leal, Joan
AU - Puig, Luis
AU - Sorlí, Luisa
AU - Morata, Laura
AU - Bori, Guillem
AU - Martínez-Pastor, Juan C.
AU - Rodríguez-Pardo, Dolors
AU - Puig-Asensio, Mireia
AU - Sordé-Masip, Roger
AU - Prats-Gispert, Laura
AU - Pérez-Villar, Ferran
AU - García-Gónzalez, Mercé
AU - Esteban, Jaime
AU - Blanco, Antonio
AU - García-Cañete, Joaquín
AU - Puente, Andrés
AU - Domecq, Gabriel
AU - Álvarez, Rocío
AU - Peñas-Espinar, Cecilia
AU - Muniain-Ezcurra, Miguel Ángel
AU - Suárez, Ana Isabel
AU - Coll, Pere
AU - Jordán, Marcos
AU - Mur, Isabel
AU - Ibarguren, Maialen
AU - de la Herrán, Gaspar
AU - Sánchez-Romero, Isabel
AU - Jiménez-Cristóbal, Javier
AU - Múñez-Rubio, Elena
AU - Muntaner, Francisco
AU - Ramírez, Antonio
AU - Fariñas, María Carmen
AU - Campo, Cristina
AU - Fakkas, Michel
AU - López-Azkarreta, Íñigo
AU - Ibarra, Sofía
AU - Cisterna, Ramón
AU - Granados, Ana
PY - 2016/9/1
Y1 - 2016/9/1
N2 - © 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.
AB - © 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.
KW - Biofilm
KW - Bone and joint infection
KW - Foreign body infection
KW - Length of therapy
KW - Osteoarticular infection
U2 - 10.1016/j.ijantimicag.2016.05.021
DO - 10.1016/j.ijantimicag.2016.05.021
M3 - Article
VL - 48
SP - 310
EP - 316
IS - 3
ER -