1. Short- versus long-duration levofloxacin plus rifampicin for acute staphylococcal prosthetic joint infection managed with implant retention: a randomised clinical trial
- Author
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Alex Soriano, Joaquín García-Cañete, Mireia Puig-Asensio, Rocío Álvarez, María Carmen Fariñas, Oscar Murillo, Dolors Rodríguez-Pardo, Francisco Muntaner, Michel Fakkas, Sofía Ibarra, Jaime Lora-Tamayo, Gaspar de la Herrán, Cristina Campo, Pere Coll, Guillem Bori, Antonio Ramos, G. Euba, Javier Ariza, Alfredo Jover-Sáenz, Luisa Sorlí, Enrique Sandoval, Juan Pablo Horcajada, N. Benito, Maialen Ibarguren, Luis Falgueras, Isabel Mur, Mercè García-González, Laura Morata, Jaime Esteban, Patricia Ruiz-Garbajosa, Ramón Cisterna, Carles Pigrau, Ferran Pérez-Villar, A. Granados, Elena Múñez-Rubio, Josu Baraia-Etxaburu, José Antonio Iribarren, Andres Puente, Cecilia Peñas-Espinar, Roger Sordé-Masip, Gabriel Domecq, Xavier Cabo, Mar Sánchez-Somolinos, Melchor Riera, Miguel Ángel Muniain-Ezcurra, Alba Ribera, Joan Leal, Ana Isabel Suárez, Antonio Ramírez, Marcos Jordán, Laura Prats-Gispert, Gema Fresco, Íñigo López-Azkarreta, María Dolores del Toro, J.C. Martínez-Pastor, Luis Puig, Isabel Sánchez-Romero, Javier Jiménez-Cristóbal, Marta Fernandez-Sampedro, Antonio Blanco, Javier Cobo, and Julián Palomino
- Subjects
0301 basic medicine ,Microbiology (medical) ,Male ,medicine.medical_specialty ,Prosthesis-Related Infections ,Time Factors ,030106 microbiology ,Prosthesis Retention ,Levofloxacin ,law.invention ,03 medical and health sciences ,Randomized controlled trial ,law ,Osteoarthritis ,medicine ,Clinical endpoint ,Humans ,Pharmacology (medical) ,Short duration ,Aged ,Aged, 80 and over ,business.industry ,Prosthetic joint infection ,General Medicine ,Middle Aged ,Surgery ,Anti-Bacterial Agents ,Clinical trial ,Infectious Diseases ,Treatment Outcome ,Debridement ,Female ,Implant ,Rifampin ,business ,Rifampicin ,medicine.drug - 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.
- Published
- 2016