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

Conditions

• Amputation
• Antibiotic Side Effect
• Fracture
• Infected Wound
• Infections
• Injury Leg
• Internal Fixation; Complications, Infection or Inflammation
• Lower Extremity Fracture
• Nonunion of Fracture

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Standard of Care PO (oral) antibiotics — DRUG
  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 — DRUG
  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.

Study Details

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.

Key Dates

Start date

May 30, 2023

Status verified

Jun 2026

Primary completion

Sep 30, 2027

Completion

Sep 29, 2028

Study Design

Enrollment

250 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

• William Obremskey, MD
  615-260-2054
  [email protected]
• Karen Trochez
  [email protected]

Locations (13)

Find similar trials in Indianapolis, IN

Related Studies

• Natural History, Management, and Genetics of the Hyperimmunoglobulin E Recurrent Infection Syndrome (HIES)
  Recruiting · National Institute of Allergy and Infectious Diseases (NIAID) · Bethesda, Maryland
• A Phase I Study of Mozobil in the Treatment of Patients With WHIMS
  PHASE1/PHASE2 · Recruiting · National Institute of Allergy and Infectious Diseases (NIAID) · Bethesda, Maryland
• Human Penile Allotransplantation
  PHASE2/PHASE3 · Recruiting · Johns Hopkins University · Baltimore, Maryland
• Hand Transplantation
  Recruiting · NYU Langone Health · New York, New York