Antibiotic Impregnated Beads in Osteomyelitis

July 9, 2025 updated by: Talha Riaz, University of Arizona

Utility of Antibiotic Impregnated Beads in Lower Extremity Osteomyelitis

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to evaluate the effectiveness of absorbable antibiotic beads in treating lower extremity (LE) infections and compare it to the current standard care. The study has several objectives: (1) to compare treatment failure rates between patients receiving intravenous (IV) and/or oral antibiotics plus antibiotic loaded absorbable beads with IV and/or oral antibiotics plus beads without antibiotics (sham beads). The primary question to be answered is whether patients treated with oral and/or IV antibiotics in conjunction with absorbable antibiotic beads have outcome (failure rate) that is not higher than those treated with standard care alone. The study's hypothesis is that the failure rate for patients receiving IV and/or oral antibiotics combined with antibiotic beads will be non-inferior to those receiving the standard care of IV or oral antibiotics without beads. The study will primarily focus on treatment failure rates as a key endpoint to measure effectiveness and compare the two treatment approaches.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • patients with lower extremity osteoarticular infections with or without hardware

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IV and/or oral antibiotics with local antibiotic loaded calcium sulfate beads
These will be patient who will receive active systemic antibiotics plus calcium sulfate beads loaded with antibiotics
Device: Calcium sulfate beads (sham beads)
Calcium sulfate beads will be prepared without added antibiotics and placed during the second surgery.
Active Comparator: IV and/or oral antibiotics plus calcium sulfate beads without antibiotics (sham beads)
These patients will receive IV and/or oral antibiotics plus sham beads. They will receive antibiotics systemically.
Drug: Antibiotic loaded calcium sulfate beads
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
End of Therapy - Clinical Failure
Time Frame: End of Therapy (usually 4-6 weeks)
  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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arizona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2025

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

September 30, 2027

Study Registration Dates

First Submitted

March 7, 2025

First Submitted That Met QC Criteria

July 9, 2025

First Posted (Estimated)

July 18, 2025

Study Record Updates

Last Update Posted (Estimated)

July 18, 2025

Last Update Submitted That Met QC Criteria

July 9, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00005515

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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