Recruiting
Phase 3

PO vs. IV Antibiotics

Sponsor:

Major Extremity Trauma Research Consortium

Code:

NCT05699174

Conditions

Infections

Infected Wound

Nonunion of Fracture

Injury Leg

Amputation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Standard of Care PO (oral) antibiotics

Standard of Care Intravenous (IV) antibiotics

Study Details

Brief summary:

This is a Phase III clinical randomized control trial to investigate differences between patient with an infected nonunion treated by PO vs. IV antibiotics. The study population will be 250 patients, 18 years or older, being treated for infected nonunion after internal fixation of a fracture with a segmental defect less than one centimeter. Patients will be randomly assigned to either the treatment (group 1) PO antibiotics for 6 weeks or the control group (group 2) IV antibiotics for 6 weeks. The primary hypothesis is that the effectiveness of oral antibiotic therapy is equivalent to traditional intravenous antibiotic therapy for the treatment of infected nonunion after fracture internal fixation, when such therapy is combined with appropriate surgical management. Clinical effectiveness will be measured as the primary outcome as the number of secondary re-admissions related to injury and secondary outcomes of treatment failure (re-infection, nonunion, antibiotic complications) within the first one year of follow-up, as defined by specified criteria and determined by a blinded data assessment panel. In addition, treatment compliance, the cost of treatment, the number of surgeries required, the type and incidence of complications, and the duration of hospitalization will be measured.

Conditions

Infections

Infected Wound

Nonunion of Fracture

Injury Leg

Amputation

Study ID

NCT05699174

Start date

May 30, 2023

Status verified date

Jun, 2026

Completion date

Sep 29, 2028

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. 1\. Bone fracture (proximal to and including the tarsal/metatarsal joint (Lisfranc) or proximal to the carpal joints (includes distal radius fractures), excluding pelvis and spine) that has previously undergone fixation and has not healed and requires fixation to be retained or replaced at least until bone union. Fractures that have not healed and require revision fixation are also eligible.
2. Infection as determined by either

1. FRI criteria
2. CDC criteria (without the timeframe) This includes the possibility of culture negative, but determined to be infection by treating surgeon
3. Systemic antibiotic treatment regimen scheduled for at least 6 weeks

Exclusion Criteria:

1. Patients with a high risk of amputation based on the initial managing physician
2. Patients undergoing treatment of any other investigational therapy within the month preceding infection treatment or planned within the 12 months following infection treatment
3. Incarcerated or institutionalized patients
4. Patients who are unable to return for required follow-up visits and/or medical co-morbidities which preclude treatment with a general anesthetic
5. Patients with a prior history of chronic infection at the index site before fracture fixation
6. Patients with pathological fractures from a neoplastic process
7. History of Paget's Disease
8. The patient, or a designated proxy, unwilling to provide consent
9. The patient must be available for follow-up for at least 12 months following infection treatment

Study Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Standard of Care PO (oral) antibiotics

An intervention in this study includes randomization of patients with an infected unhealed fracture to standard of care PO (oral) antibiotics for up to 6 weeks post hospitalization. No medications will be provided by the study. Study participants will be prescribed their oral antibiotics by their treating physician and the specific type will depend on their infection diagnosis. Medications will be obtained using health insurance and/or resources available at the treating facility therefore the mode of antibiotics utilized as standard of care will vary across participating sites. Sites will follow their standard of care delivery for antibiotics, and the study will defer to this standard.

active comparator: Standard of Care Intravenous (IV) antibiotics

An intervention in this study includes randomization of patients with an infected unhealed fracture to intravenous (IV) antibiotics for up to 6 weeks post hospitalization. No medications will be provided by the study. Study participants will be prescribed their IV antibiotics by their treating physician and the specific type will depend on their infection diagnosis. Medications will be obtained using health insurance and/or resources available at the treating facility therefore the mode of antibiotics utilized as standard of care will vary across participating sites. Sites will follow their standard of care delivery for antibiotics, and the study will defer to this standard.

Interventions

Standard of Care PO (oral) antibiotics

An intervention in this study includes randomization of patients with an infected nonunion to PO (oral) antibiotics for up to 6 weeks post hospitalization. The exact type of oral antibiotic will be depended on the patient's infection diagnosis.

Standard of Care Intravenous (IV) antibiotics

An intervention in this study includes randomization of patients with an infected nonunion to intravenous (IV) antibiotics for up to 6 weeks post hospitalization. The exact type of IV antibiotic will be depended on the patient's infection diagnosis.

Primary outcome measure

  • Number of patients with a hospital re-admission [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

William Obremskey, MD

615-260-2054william.obremskey@vumc.org

Karen Trochez

karen.m.trochez@vumc.org

Locations

Indiana University

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Lauren Hill, BS

hilllc@iu.edu

Principal Investigator:

Roman Natoli, MD

University of Maryland , MD Department of Orthopaedics

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Yasmin Degani, MPH

ydegani@som.umaryland.edu

Principal Investigator:

Robert O'Toole, MD

Hennepin Health

Recruiting

Minneapolis, Minnesota, United States, 55487

Contacts

Olutayo Alese

612-873-4634olutayo.alese@hcmed.org

Principal Investigator:

Andrew Schmidt, MD

Wake Forest University Baptist Medical Center

Recruiting

Winston-Salem, North Carolina, United States, 27106

Contacts

Martha Holden

mholden@wakehealth.edu

Principal Investigator:

Sharon Babock, MD

Penn State University M.S. Hershey Medical Center

Recruiting

Hershey, Pennsylvania, United States, 17033

Contacts

Andrea Myers, BSN

amyers1@pennstatehealth.psu.edu

Principal Investigator:

J. Spence Reid, MD

Vanderbilt Medical Center

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Karen Trochez

karen.m.trochez@vumc.org

Principal Investigator:

William Obremskey, MD

University of Washington Harborview Medical Center

Recruiting

Seattle, Washington, United States, 98195

Contacts

Jessica Schisel

jrod24@uw.edu

Principal Investigator:

Michael Githens, MD

University of Wisconsin

Recruiting

Madison, Wisconsin, United States, 53705

Contacts

Brittany Grasso

otrc@ortho.wisc.edu

Principal Investigator:

Paul Whiting, MD

More Information

Sponsor

Major Extremity Trauma Research Consortium

Last update posted

Jun 11, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Major Extremity Trauma Research Consortium on 2026-06-11.