PO vs IV Antibiotics for the Treatment of Infected Nonunion of Fractures After Fixation

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
• Internal Fixation; Complications, Infection or Inflammation
• Fracture
• Lower Extremity Fracture
• Antibiotic Side Effect

Interventions

DRUG

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.

DRUG

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.

Sponsors & Collaborators

• United States Department of Defense

  collaborator FED

• Major Extremity Trauma Research Consortium

  lead OTHER

Principal Investigators

• William Obremskey, MD · Vanderbilt Medical Center

• Renan Castillo, PhD · Johns Hopkins Bloomberg School of Public Health

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-05-30

Primary Completion

2026-09-30

Completion

2027-09-29

Countries

• United States

Study Locations