Antibiotic Impregnated Beads in Osteomyelitis

NCT07072923 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: STUDY00005515
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Osteomyelitis of the Foot; Antibiotic Impregnated Beads; Osteomyelitis of Lower Extremities

Keywords

osteomyelitis, lower extremity, foot, calcium sulfate beads

Outcome Measures

Primary Outcomes (1)

• End of Therapy - Clinical Failure

  1. Presence of at least one clinical criterium for failure (frank pus adjacent to bone or implant or draining sinus tract), OR 2. phenotypically indistinguishable bacteria isolated from two or more deep-tissue samples or a single closed aspirate or biopsy OR 3. histologic criteria including presence of characteristic inflammatory infiltrate or microorganisms.

  End of Therapy (usually 4-6 weeks)

Study Arms (2)

IV and/or oral antibiotics with local antibiotic loaded calcium sulfate beads

EXPERIMENTAL

These will be patient who will receive active systemic antibiotics plus calcium sulfate beads loaded with antibiotics

Device: Calcium sulfate beads (sham beads)

IV and/or oral antibiotics plus calcium sulfate beads without antibiotics (sham beads)

ACTIVE COMPARATOR

These patients will receive IV and/or oral antibiotics plus sham beads. They will receive antibiotics systemically.

Drug: Antibiotic loaded calcium sulfate beads

Interventions

Antibiotic loaded calcium sulfate beads DRUG

Calcium sulfate beads will be loaded with best available antibiotics based on surgeon/infectious disease specialist determination from the following options (vancomycin, daptomycin, cefazolin, cefepime, tobramycin, amphotericin B, micafungin, and voriconazole).

IV and/or oral antibiotics plus calcium sulfate beads without antibiotics (sham beads)

Calcium sulfate beads (sham beads) DEVICE

Calcium sulfate beads will be prepared without added antibiotics and placed during the second surgery.

IV and/or oral antibiotics with local antibiotic loaded calcium sulfate beads

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with lower extremity osteoarticular infections with or without hardware

You may not qualify if:

• patients who are hemodynamically unstable or have altered mental status and cannot give consent
• patient per investigators discretion are excluded

Sponsors & Collaborators

• University of Arizona: lead

MeSH Terms

Conditions

Osteomyelitis

Condition Hierarchy (Ancestors)

Bone Diseases, Infectious; Infections; Bone Diseases; Musculoskeletal Diseases

Central Study Contacts

Talha Riaz, MD

CONTACT

+1 520 626 8569; riazt@arizona.edu

Jose Elizondo

CONTACT

+15206210316; joselizondo5@arizona.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Randomization table will be prepared with treatment allocation specified in sealed envelopes. Participants are assigned a study number sequentially after consent is obtained. The surgeon and infectious disease specialist will develop a plan for IV and/or oral antibiotics based on culture results from the initial surgery. In addition, they will develop a plan for local antibiotics to be incorporated in the calcium sulfate beads. Antibiotics will actually be added only if the patient is assigned to the treatment group. The Investigator will then pull the envelope for the prospective study number and obtain the assigned treatment (antibiotic loaded beads versus sham beads). The calcium sulfate beads (with or without antibiotics will be placed during the second surgical procedure.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: This is a randomized, single blinded, prospective clinical trial where the treatment group will receive IV and/or oral antibiotics plus antibiotic impregnated beads, and the control group will receive IV and/or oral antibiotics plus calcium sulfate beads without antibiotics (sham beads). Systemic antibiotics therapy and the antibiotics contained in the antibiotic impregnated beads will be best available agents determined by the surgeon and infectious disease specialist.

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: July 18, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: July 18, 2025

Record last verified: 2025-07