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

PHASE3RecruitingINTERVENTIONAL
Enrollment

250

Participants

Timeline

Start Date

May 30, 2023

Primary Completion Date

September 30, 2026

Study Completion Date

September 29, 2027

Conditions
InfectionsInfected WoundNonunion of FractureInjury LegAmputationInternal Fixation; Complications, Infection or InflammationFractureLower Extremity FractureAntibiotic 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.

Trial Locations (11)

10003

RECRUITING

NYU Langone Medical Center, New York

17033

RECRUITING

Penn State University M.S. Hershey Medical Center, Hershey

21201

RECRUITING

University of Maryland , MD Department of Orthopaedics, Baltimore

27106

RECRUITING

Wake Forest University Baptist Medical Center, Winston-Salem

28207

NOT_YET_RECRUITING

Atrium Health, Carolinas Medical Center, Charlotte

37203

RECRUITING

Vanderbilt Medical Center, Nashville

46202

RECRUITING

Indiana University, Indianapolis

53705

RECRUITING

University of Wisconsin, Madison

55487

NOT_YET_RECRUITING

Hennepin Health, Minneapolis

77030

NOT_YET_RECRUITING

University of Texas Health Science Center at Houston, Houston

98195

NOT_YET_RECRUITING

University of Washington Harborview Medical Center, Seattle

All Listed Sponsors
collaborator

United States Department of Defense

FED

lead

Major Extremity Trauma Research Consortium

OTHER