Controlled Trial of Omadacycline Randomized Treatment Given for Bone and Joint Infection

Summary

The study design is a randomized, open-label, clinical trial of omadacycline vs Standard of Care (SOC) antibiotics for bone and join infection (BJI) treatment. Study participants will have their BJI regimen chosen by their treating physicians, (typically Infectious Diseases for hardware and prosthetic joint infections, or multidisciplinary Limb Salvage team for diabetic foot infections) prior to enrollment. Then participants will be randomized to an omadacycline-containing regimen versus the a priori chosen SOC regimen. Participants must require between 4 and 12 weeks of therapy for their BJI. The exact duration of therapy will be decided by the participants' treating physician. At 12 weeks, if the treating physician wishes to extend therapy, participants receiving omadacycline will be transitioned to other SOC antibiotics.

Once enrolled, participants will be followed via in-person clinic visits at the following intervals: weeks 0, 2, 4, 8, and 12. A final in-person visit will occur 2 weeks post-treatment completion. A phone survey will occur 3 months post-treatment completion. Participants in the SOC group will follow the same schedule.

Oral once-daily dosing options for S. aureus and Coagulase negative Staphylococcus are essentially non-existent. Thus, omadacycline possesses a novel and advantageous option for BJI treatment. Its convenient dosing regimen will almost certainly be associated with improved adherence, and higher adherence may, in turn, improve clinical outcome. Investigators hypothesize that omadacycline will be a well-tolerated and efficacious oral antibiotic for BJIs and will be associated with improved adherence compared with standard of care oral antibiotics. Investigators believe omadacycline addresses the unmet need for an oral antibiotic that is well-tolerated and efficacious for use as a prolonged therapy for BJIs. To this aim, investigators will perform a randomized, open-label clinical trial of omadacycline to SOC antibiotics for BJIs.

Conditions

• Bone Infection
• Joint Infection
• Bone and Joint Infection

Interventions

DRUG

Omadacycline Pill

Omadacycline will be administered 300 mg orally daily without the loading dose.

DRUG

Standard of Care

Prior to randomization, SOC antibacterial therapy will be selected by the subject's treating physician.

Sponsors & Collaborators

• Chapman University

  collaborator OTHER

• Paratek Pharmaceuticals Inc

  collaborator INDUSTRY

• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

  lead OTHER

Principal Investigators

• Loren G. Miller, MD, MPH · The Lundquist Institute For Biomedical Innovation at Harbor-UCLA Medical Center

• Amy Y. Kang, PharmD, BCIDP · Chapman Univeristy

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-05-09

Primary Completion

2026-02-28

Completion

2026-06-30

FDA Drug

Yes

Countries

• United States

Study Locations