6 weeks of antibiotics not better than 12 weeks for prosthetic joint infection
The results of a randomized controlled trial demonstrated that a 6-week course of antibiotics for prosthetic joint infection was not noninferior to a 12-week course and resulted in a higher percentage of patients with unfavorable outcomes.
“The management of prosthetic joint infection usually consists of a combination of surgery and antimicrobial therapy,” Louis Bernard, MD, PhD, of the University Hospital Bretonneau’s division of infectious diseases, and colleagues wrote in The New England Journal of Medicine. “The appropriate duration of antimicrobial therapy for this indication remains unclear.”
Bernard and colleagues conducted an open-label, randomized, controlled, noninferiority trial called DATIPO (Duration of Antibiotic Treatment in Prosthetic Joint Infection) that compared 6 weeks of antibiotic therapy with 12 weeks of antibiotic therapy among patients with microbiologically confirmed prosthetic joint infection that had been managed with standard surgical procedures.
The primary outcome was persistent infection within 2 years after completion of antibiotic therapy.
The researchers randomly assigned 410 patients to receive antibiotic therapy for 6 weeks (n = 205) or for 12 weeks (n = 205). They excluded 20 patients who died during follow-up and considered six others who were lost to follow-up to be persistently infected.
According to the study, persistent infection occurred in 35 of 193 patients (18.1%) in the 6-week group and in 18 of 191 patients (9.4%) in the 12-week group (95% CI, 1.8-15.6).
According to Bernard and colleagues, the per-protocol and sensitivity analyses also did not demonstrate noninferiority of the shorter therapy, and there were no between-group differences in the percentage of patients with treatment failure due to a new infection, probable treatment failure or serious adverse events.
“This trial showed that a shorter course of 6 weeks of antibiotic therapy did not meet the criterion for noninferiority to a longer course of 12 weeks in the treatment of prosthetic joint infection and resulted in unfavorable outcomes in a higher percentage of patients, most of whom had undergone debridement with implant retention,” the authors wrote. “This difference in risk seemed to be less marked among the patients who had undergone one-stage or two-stage implant exchange, but this observation remains to be explored in a specific randomized trial.”