drugset / Trial / NCT07072923

Antibiotic Impregnated Beads in Osteomyelitis

NCT07072923

Phase 4 Not yet recruiting 100 enrolled University of Arizona
RandomizedParallel-groupSingle-blindTreatment

Summary

Lower extremity bone infections, such as osteomyelitis, often occur after bone fractures, surgery, or when prosthetic joints or hardware become infected. Treatment usually includes antibiotics, chosen based on the infection's specifics. Options include intravenous (IV) or oral antibiotics, and sometimes local treatment with antibiotic-loaded beads placed directly at the infection site. Traditionally, these beads are made of non-absorbable materials, requiring a second surgery to remove them. However, a newer approach uses absorbable calcium sulfate beads, which can deliver higher antibiotic doses and don't need removal. This study will compare the use of IV and/or antibiotics in combination with absorbable antibiotic calcium sulfate beads with IV and/or oral antibiotics without absorbable beads, which serves as the current standard of care.

Timeline

Start
2025-09-01
Primary completion
2027-07-31
Completion
2027-09-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Amphotericin B Unknown
Comparator Cefazolin Small molecule
Comparator Cefepime Small molecule
Comparator Daptomycin Other / unclassified
Comparator Micafungin Peptide
Comparator Tobramycin Small molecule
Comparator Vancomycin Other / unclassified
Comparator Voriconazole Small molecule

Indications