Randomized Trial to Assess PO Versus IV Antibiotics



Status:Recruiting
Conditions:Infectious Disease, Hospital
Therapuetic Areas:Immunology / Infectious Diseases, Other
Healthy:No
Age Range:18 - 84
Updated:9/7/2018
Start Date:December 3, 2013
End Date:September 30, 2020
Contact:Craig Remenapp, MS
Email:cremena1@jhu.edu
Phone:410-614-3576

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A Prospective Randomized Trial to Assess PO Versus IV Antibiotics for the Treatment of Post-op Wound Infection After Extremity Fractures (POvIV)

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: 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.

Not provided here. Details listed above.

Inclusion Criteria:

1. 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

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:

1. Patients who have high risk of amputation of the study limb (based on opinion of the
initial managing physician).

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).
We found this trial at
25
sites
34800 Bob Wilson Dr,
San Diego, California 92134
(619) 532-6400
Naval Medical Center - San Diego We are the largest and most comprehensive military healthcare...
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Candice Dubose, MD
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Birmingham, AL
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1000 Blythe Blvd
Charlotte, North Carolina 28203
(704) 355-2000
Principal Investigator: Catherine Passaretti, MD
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Charlotte, NC
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3300 Gallows Road
Falls Church, Virginia 22042
(703) 776-4001
Principal Investigator: Robert Hymes, MD
Inova Fairfax Hospital Inova Fairfax Hospital, Inova's flagship hospital, is an 833-bed, nationally recognized regional...
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Falls Church, VA
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Principal Investigator: Charles Moon, MD
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Los Angeles, CA
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: William T. Obremskey, MD, MPH
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Nashville, TN
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620 John Paul Jones Cir
Portsmouth, Virginia 23708
(757) 953-5008
Principal Investigator: Christopher Smith, MD
Naval Medical Center - Portsmouth Naval Medical Center Portsmouth, Virginia has proudly served the military...
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Portsmouth, VA
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Baltimore, Maryland 21201
Principal Investigator: Robert O'Toole, MD
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Baltimore, MD
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Boston, Massachusetts 02118
Principal Investigator: Paul Tornetta, MD
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Boston, MA
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Charlottesville, Virginia 22903
(434) 924-0311
Principal Investigator: David Weiss, MD
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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2500 Metrohealth Dr
Cleveland, Ohio 44109
(216) 778-7800
Principal Investigator: Heather Vallier, MD
MetroHealth Med Ctr The MetroHealth System is one of the largest, most comprehensive health care...
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Cleveland, OH
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Denver, Colorado 80204
Principal Investigator: Cyril Mauffrey, MD
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Denver, CO
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Hershey, Pennsylvania 17033
Principal Investigator: J. Spence Reid, MD
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650 Eskenazi Avenue
Indianapolis, Indiana 46202
Principal Investigator: Brian Mullis, MD
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Indianapolis, IN
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200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
Principal Investigator: J Lawrence Marsh, MD
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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Iowa City, IA
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Jamaica, New York 11418
Principal Investigator: Sanjit Konda, MD
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Jamaica, NY
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Madison, Wisconsin 53792
(608) 263-2400
Principal Investigator: Paul Whiting, MD
University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
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Madison, WI
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Miami, Florida 33101
Principal Investigator: Gregory Zych, MD
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Miami, FL
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Minneapolis, Minnesota 55414
Principal Investigator: Andrew Schmidt, MD
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Minneapolis, MN
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New York, New York 10016
Principal Investigator: Sanjit Konda, MD
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New York, NY
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3635 Vista Avenue
Saint Louis, Missouri 63110
Principal Investigator: Lisa Cannada, MD
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Saint Louis, MO
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San Antonio, Texas 78234
Principal Investigator: Dan Stinner, MD
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San Francisco, California 94143
Principal Investigator: Saam Morshed, MD
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Seattle, Washington 98104
Principal Investigator: Reza Firoozabadi, MD
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Winston-Salem, North Carolina 27157
Principal Investigator: Jason Halvorson, MD
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