Oral noninferior to IV antibiotics for fracture-related infections

In the treatment of fracture-related infections, outcomes appear to be comparable when using oral vs intravenous (IV) antibiotics, according to a study.

The study was conducted at 24 trauma centres across the US and included 233 adult patients (mean age 46.0 years, 22.7 percent female) who had fracture repair or arthrodesis with fixation with implants and contracted a fracture-related infection without radiographic evidence of osteomyelitis. These patients had cultures indicating organisms were sensitive to available oral or IV antibiotics or had a culture-negative infection, had no drug allergies or interactions, and could be treated with either oral or IV antibiotics.

The patients were then randomly assigned to receive oral vs IV antibiotics. Those in the IV group were allowed to receive adjuvant therapy of oral rifampin and be considered adherent. All patients were followed up for 1 year after discharge from the initial infection hospitalization.

The primary outcome was the number of surgical interventions, while the secondary outcome was a recurrence of a deep surgical site infection.

During the 1-year follow-up, the mean number of surgical interventions was 1.3 in the oral group vs 1.1 in the IV group. In the unadjusted modified intention-to-treat (mITT) analysis, the upper bound of the 95 percent confidence interval of the mean difference of 0.59 was lower than the prespecified margin of 0.67, establishing noninferiority of oral to IV antibiotics.

Adjusted per-protocol analysis did not support noninferiority of the oral vs IV antibiotics for the number of reoperations, whereas a post hoc adjusted mITT analysis did show noninferiority.

Results for the secondary outcome were consistent to those obtained for the primary outcome.