Randomized Trial to Assess PO Versus IV Antibiotics

Completed · Not applicable

Conditions studied: Wound Infection

In brief

The goal of this study is to evaluate the effect of treatment of post-op wound infection in long bones after fracture fixation or joint fusion and either: (Group 1) operative debridement and PO antibiotic treatment for 6 weeks; or (Group 2) operative debridement and IV antibiotics for 6 weeks. Primary Hypothesis 1: The rate of study injury related surgical interventions by one year in Group 1 will be non-inferior to the rate in Group 2. Secondary Hypothesis 1: The rate of treatment failure by one year in Group 1 will be non-inferior to the rate in Group 2. Treatment failure is defined as wound problems that require surgery \>2 weeks after initial debridement, infection recurrence, infection with a new pathogen, joint erosion, implant failure, medical problems related to the treatment administration which necessitates a switch from one arm to the other. Secondary Hypothesis 2: The rate of re-hospitalization for complications, infection, non-union and amputation by one year in Group 1 will be non-inferior to the rate in Group 2. Secondary Hypothesis 3: Following discharge for treatment of infection, per patient treatment costs at 1 year will be lower in Group 1 than in Group 2. Secondary Hypothesis 4: Adherence in Group 1 will be non-inferior to adherence in Group 2. Secondary Hypothesis 5: Patient satisfaction with treatment in Group 1 will be non-inferior to adherence in Group 2. Specific Aim 2: To build and validate a risk prediction model for failure of treatment of early post-op wound infections after fixation of fractures and joint fusions.

Key facts

Study ID: NCT01714596
Run by: Major Extremity Trauma Research Consortium
People needed: 233
Starts: 2013-12-03
Expected to finish: 2020-12-30
Last updated by the study team: 2021-02-11

Who can join

Age: 18 and older, up to 84. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients with any fractures of any bone at or proximal to and including the tarsal/metatarsal joint (Lisfranc) or proximal to the carpal joints (includes distal radius fractures), excluding the spine, treated with any type of internal fixation, or
Patients undergoing fusion of any bone at or proximal to and including the subtalar joint or radial carpal joint, (excluding the spine) that develop a post op wound infection at any time.
Patients diagnosed with a wound infection of the study injury, defined as patients with at least one of the following:
Deep culture positive after operative debridement.
Cultures positive in thio only after operative debridement.
Negative culture after operative debridement if wound infection meets the Center for Disease control and Prevention (CDC) criteria.
Patients who are English or Spanish competent.
Patients aged 18 - 84.
Patients with bacteria susceptible to both PO and IV antibiotics.
Patients able to be treated for their infection at the METRC facility for at least 12 months following definitive surgical procedure
Patients may have multiple eligible study-eligible injuries.
Patients may have temporary external fixation prior to definitive fixation.
Patients may have received antibiotics prior to operative wound debridement.
Patient is able to obtain study medication(s).
Patient may be pregnant at the time of screening.

You may not qualify if…

Patients who have high risk of amputation of the study limb (based on opinion of the initial managing physician).
Patients undergoing treatment with any other investigational therapy within the month preceding implantation or planned within the 12 months following implantation.
Patients with history of chronic infection at the site of study injury, defined as:
patients with chronic osteomyelitis identified by radiographic erosion or sequestrum; or patients with more than one instance of surgical treatment of infection and approximately 6 week course of antibiotics.
Patients with pathological fractures; a known history of Paget's disease.
Patients for whom the definitive treatment of the study injury was an external fixator.
Patients who are currently on Selective Serotonin Reuptake Inhibitor (SSRI) medication (e.g. Zoloft, Prozac, Celexa), and bacteria is MRSA
Patients with cultures positive in thio only.
Patients who are incarcerated or who have unstable housing situations due to concerns regarding ability to receive home care, adherence phone calls, and maintain follow up. .
Patients or designated proxy who are unwilling to provide consent.
Patients with a history of IV drug use who in the investigator's opinion are unsuitable candidates for IV therapy.
Patients likely to have severe problems maintaining follow-up, including patients diagnosed with a severe psychiatric conditions, patients who live too far outside the hospital's catchment area.
Patients with traumatic brain injury or who are intellectually challenged and who lack adequate family support to ensure adherence to the protocol.
Patients unable to swallow oral medications or without adequately functioning GI tract.
Patients who, based upon the clinical judgment of the treating clinician, are NOT equally suited for treatment with either oral or intravenous antibiotics (i.e., those for whom there is a clinical treatment preference).

Where it is running

University of Alabama at Birmingham — Birmingham, Alabama, United States
Cedars Sinai Medical Center — Los Angeles, California, United States
University of California at San Francisco — San Francisco, California, United States
Denver Health and Hospital Authority — Denver, Colorado, United States
University of Miami Ryder Trauma Center — Miami, Florida, United States
Eskenazi Health — Indianapolis, Indiana, United States
University of Iowa Hospitals & Clinics — Iowa City, Iowa, United States
University of Maryland R Adams Cowley Shock Trauma Center — Baltimore, Maryland, United States
Boston Medical Center — Boston, Massachusetts, United States
Hennepin County Medical Center — Minneapolis, Minnesota, United States
St. Louis University Medical Center — St Louis, Missouri, United States
Jamaica Hospital Medical Center — Jamaica, New York, United States
NYU Langone Medical Center — New York, New York, United States
Carolinas Medical Center — Charlotte, North Carolina, United States
Wake Forest Baptist Medical Center — Winston-Salem, North Carolina, United States
MetroHealth Medical Center — Cleveland, Ohio, United States
Penn State University M.S. Hershey Medical Center — Hershey, Pennsylvania, United States
Vanderbilt University Medical Center — Nashville, Tennessee, United States
San Antonio Military Medical Center (SAMMC) — San Antonio, Texas, United States
University of Virginia — Charlottesville, Virginia, United States
Inova Fairfax Hospital — Falls Church, Virginia, United States
Naval Medical Center Portsmouth — Portsmouth, Virginia, United States
University of Washington/Harborview Medical Center — Seattle, Washington, United States
University of Wisconsin — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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