Study Results
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Basic Information
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COMPLETED
NA
233 participants
INTERVENTIONAL
2013-12-03
2020-12-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Oral Antibiotic
Oral Antibiotic Arm; Participants assigned to this group will receive oral antibiotics as prescribed by their treating physician.
PO versus IV antibiotics Route of administration evaluation
This is a study of oral (per os, (PO)) antibiotic therapy versus intravenous (IV) antibiotics in the treatment of acute infection after fixation of fractures and joint fusions. This is not a study of an experimental drug but a study of route of administration of standard use antibiotics. Antibiotic regimen options decision will be made by the Study Surgeon at each site in consult with local Infectious Disease experts based on local standard practices and bacterial susceptibilities.
IV Antibiotic
Participants assigned to this group will receive intravenous (IV) antibiotics as prescribed by their treating physician.
PO versus IV antibiotics Route of administration evaluation
This is a study of oral (per os, (PO)) antibiotic therapy versus intravenous (IV) antibiotics in the treatment of acute infection after fixation of fractures and joint fusions. This is not a study of an experimental drug but a study of route of administration of standard use antibiotics. Antibiotic regimen options decision will be made by the Study Surgeon at each site in consult with local Infectious Disease experts based on local standard practices and bacterial susceptibilities.
Interventions
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PO versus IV antibiotics Route of administration evaluation
This is a study of oral (per os, (PO)) antibiotic therapy versus intravenous (IV) antibiotics in the treatment of acute infection after fixation of fractures and joint fusions. This is not a study of an experimental drug but a study of route of administration of standard use antibiotics. Antibiotic regimen options decision will be made by the Study Surgeon at each site in consult with local Infectious Disease experts based on local standard practices and bacterial susceptibilities.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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.
3. Patients diagnosed with a wound infection of the study injury, defined as patients with at least one of the following:
1. Deep culture positive after operative debridement.
2. Cultures positive in thio only after operative debridement.
3. Negative culture after operative debridement if wound infection meets the Center for Disease control and Prevention (CDC) criteria.
4. Patients who are English or Spanish competent.
5. Patients aged 18 - 84.
6. Patients with bacteria susceptible to both PO and IV antibiotics.
7. Patients able to be treated for their infection at the METRC facility for at least 12 months following definitive surgical procedure
8. Patients may have multiple eligible study-eligible injuries.
9. Patients may have temporary external fixation prior to definitive fixation.
10. Patients may have received antibiotics prior to operative wound debridement.
11. Patient is able to obtain study medication(s).
12. Patient may be pregnant at the time of screening.
Exclusion Criteria
2. Patients undergoing treatment with any other investigational therapy within the month preceding implantation or planned within the 12 months following implantation.
3. 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.
4. Patients with pathological fractures; a known history of Paget's disease.
5. Patients for whom the definitive treatment of the study injury was an external fixator.
6. Patients who are currently on Selective Serotonin Reuptake Inhibitor (SSRI) medication (e.g. Zoloft, Prozac, Celexa), and bacteria is MRSA
7. Patients with cultures positive in thio only.
8. 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. .
9. Patients or designated proxy who are unwilling to provide consent.
10. Patients with a history of IV drug use who in the investigator's opinion are unsuitable candidates for IV therapy.
11. 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.
12. Patients with traumatic brain injury or who are intellectually challenged and who lack adequate family support to ensure adherence to the protocol.
13. Patients unable to swallow oral medications or without adequately functioning GI tract.
14. 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).
18 Years
84 Years
ALL
No
Sponsors
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Major Extremity Trauma Research Consortium
OTHER
Responsible Party
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Principal Investigators
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William T Obremskey, MD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center
Renan Castillo, PhD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins Bloomberg School of Public Health
Tara Taylor, MPH
Role: STUDY_DIRECTOR
Johns Hopkins Bloomberg School of Public Health
Locations
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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
Countries
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References
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Major Extremity Trauma Research Consortium (METRC); Obremskey WT, O'Toole RV, Morshed S, Tornetta P 3rd, Murray CK, Jones CB, Scharfstein DO, Taylor TJ, Carlini AR, DeSanto JM, Castillo RC, Bosse MJ, Karunakar MA, Seymour RB, Sims SH, Weinrib DA, Churchill C, Carroll EA, Pilson HT, Goodman JB, Holden MB, Miller AN, Sietsema DL, Stahel PF, Mir H, Schmidt AH, Westberg JR, Mullis B, Shively KD, Hymes RA, Konda SR, Vallier HA, Breslin MA, Smith CS, Crickard CV, Reid JS, Baker M, Eglseder WA, LeBrun C, Manson T, Mascarenhas DC, Nascone J, Pollak AN, Schloss MG, Sciadini MF, Degani Y, Miclau T, Weiss DB, Yarboro SR, McVey ED, Firoozabadi R, Agel J, Burgos EJ, Gajari V, Rodriguez-Buitrago A, Tummuru RR, Trochez KM. Oral vs Intravenous Antibiotics for Fracture-Related Infections: The POvIV Randomized Clinical Trial. JAMA Surg. 2025 Mar 1;160(3):276-284. doi: 10.1001/jamasurg.2024.6439.
Other Identifiers
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METRC POvIV
Identifier Type: -
Identifier Source: org_study_id
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