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The study aims to determine whether 8 weeks of antibiotics is non-inferior to 12 weeks in patients with acute deep spinal implant infection (SII). In the retrospective study of all SII cases (2009-2016), patients aged ≥ 15 years with microbiologically confirmed SII treated with debridement and implant retention were included. Whenever possible, tailored antibiotic treatment was used: rifampin/linezolid in gram-positive and quinolones in gram-negative infection. Patients were divided into short treatment course (8 weeks, ST group) and extended treatment (12 weeks, ET group). Primary outcome measure was percentage of cures at 1-year follow-up. One-hundred-twenty-four patients considered, 48 excluded based on the above criteria, leaving 76 patients, 28 ST and 48 ET. There were no differences in patient age, comorbidities, underlying pathologies, infection location, or surgery characteristics between groups. Surgery-to-debridement time was similar (18.5-day ST vs. 19-day ET; P = 0.96). Sixteen SII cases (21.1%) occurred with bloodstream infection. Pathogens found were Enterobacteriaceae (35, 46.1%), Staphylococcus aureus (29, 38.2%), coagulase-negative staphylococci (12, 15.8%), Pseudomonas aeruginosa (12, 15.8%), and Enterococcus faecalis (7, 9.2%). Twenty seven (35.5%) had polymicrobial infection. E. faecalis was more frequent in the ST group (7, 25% vs. 0; P < 0.001), and P. aeruginosa in ET (1, 3.6% vs. 11, 22.9%; P = 0.05). Five patients died of causes unrelated to SII. At 1-year follow-up, cure rates (21/26 ST, 80.8% vs. 39/45 ET, 86.7%; P = 0.52) and recurrences (2/26, 7.7% vs. 2/45, 4.4%; P = 0.62) were similar. Eight-week antimicrobial courses were not inferior to 12 weeks in patients with acute deep SII treated with prompt debridement, proper wound healing, and optimized antibiotics.
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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.
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