Treatment of prosthetic joint infection usually involves a combination of surgery and antimicrobial treatment. The appropriate duration of antimicrobial therapy for this indication remains unclear.
Methods
We conducted an open-label, randomized, controlled, noninferiority trial to compare 6 weeks with 12 weeks of antibiotic therapy in patients with microbiologically confirmed prosthetic joint infection that had been treated with an appropriate surgical procedure.
The primary outcome was persistent infection (defined as persistence or recurrence of infection with the initial causative bacteria, with a pattern of antibiotic susceptibility that was phenotypically indistinguishable from that at enrollment) within 2 years after completion of antibiotic therapy.
Non -inferiority from 6 weeks of therapy to 12 weeks of therapy would be shown if the upper limit of the 95% confidence interval for the absolute difference between groups (the value in the 6-week group minus the value in the 12-week group ) in the percentage of patients with persistent infection within 2 years was not greater than 10 percentage points.
Results
A total of 410 patients from 28 French centers were randomly assigned to receive antibiotic therapy for 6 weeks (205 patients) or for 12 weeks (205 patients).
Six patients who withdrew consent were not included in the analysis. In the main analysis, 20 patients who died during follow-up were excluded, and missing results of 6 patients who were lost to follow-up were considered persistent infection.
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 (risk difference, 8.7 percentage points; 95% confidence interval, 1.8 to 15.6); therefore, noninferiority was not demonstrated.
Non-inferiority was also not shown in the per-protocol and sensitivity analyses.
We found no evidence of differences between groups in the percentage of patients with treatment failure due to new infection, probable treatment failure, or serious adverse events.
Conclusions Among patients with microbiologically confirmed prosthetic joint infections who were treated with standard surgical procedures, antibiotic therapy for 6 weeks was found to be noninferior to antibiotic therapy for 12 weeks and resulted in a higher percentage of patients with unfavorable outcomes. |
(Funded by Program Hospitalier de Recherche Clinique, French Ministry of Health; ClinicalTrials.gov DATATYPE number, NCT01816009. Opens in new tab.)
