A Prospective Randomized Trial to Assess PO Versus IV Antibiotics for Wound Infection of Extremity Fractures (POvIV)
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Purpose
The goal of this study is to evaluate the effect of treatment of early post-op wound infection in long bones treated with plate fixation 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.
| Condition | Intervention |
|---|---|
|
Wound Infection |
Other: PO versus IV antibiotics Route of administration evaluation |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Prospective Randomized Trial to Assess PO Versus IV Antibiotics for the Treatment of Early Post-op Wound Infection After Plate Fixation of Extremity Fractures (POvIV Study) |
- Primary objective: investigate the efficacy of oral (PO) antibiotic therapy versus intravenous (IV) antibiotics in the treatment of acute infection after plate fixation of fractures. [ Time Frame: 4 Years ] [ Designated as safety issue: No ]Phase III randomized controlled clinical trial to investigate efficacy of PO vs. IV antibiotics in the treatment of early (<6 weeks) post-operative wound infections. Clinical efficacy will be measured by the incidence of treatment failure within the first one-year of follow-up as defined by culture positive recurrence of infection prior to bony union, progressive radiographic plate loosening, joint erosion due to infection that results in amputation or joint fusion, development of adverse reactions to antibiotics that cause change in form of administration.
- Patient Adherence [ Time Frame: 4 Years ] [ Designated as safety issue: No ]Patient adherence with PO antibiotics will be monitored through wireless-enabled microchip monitors embedded in pill bottles. The Home Health agency administering the IV antibiotics will be contacted to assess adherence with IV antibiotic regimen by assessing utilization of supplied antibiotics.
| Estimated Enrollment: | 600 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | December 2016 |
| Estimated Primary Completion Date: | December 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Oral Antibiotic
Oral Antibiotic Arm; Participants assigned to this group will receive oral antibiotics as prescribed by their treating physician.
|
Other: 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 plate fixation of fractures. 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 suceptibilities.
Other Name: based on local practices and bacterial susceptibilities
|
|
Active Comparator: IV Antibiotic
Participants assigned to this group will receive intravenous (IV) antibiotics as prescribed by their treating physician.
|
Other: 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 plate fixation of fractures. 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 suceptibilities.
Other Name: based on local practices and bacterial susceptibilities
|
Detailed Description:
Not provided here. Details listed above.
Eligibility| Ages Eligible for Study: | 18 Years to 84 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with long bone fractures (defined as femurs, tibias, and fibulas of the legs, and the humeri, radii, and ulnas of the arms) treated with a plate that will be retained until union.
- Patients diagnosed with a wound infection of the study injury, defined as deep culture positive after operative debridement, within six weeks of definitive fixation.
- 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 a segmental defect of fracture up to 1 cm.
- Patients may have temporary external fixation prior to definitive fixation.
- Patients may have received antibiotics prior to open wound debridement.
- Patient is able to obtain study medication(s).
- Patient may be pregnant at the time of screening.
Exclusion Criteria:
- Patients who are skeletally immature (defined as less than 18 years of age or no radiographic evidence of epiphyseal closure).
- 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 prior history of infection at the site of study injury.
- Patients with segmental defects greater than 1 cm in length at the site of study injury.
- 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), except those with gram negative bacteria.
- Patients whose study injury was definitively closed with cement containing antibiotics. (Beads may be placed at initial debridement but must be removed prior to definitive wound or flap closure).
- 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).
Contacts and Locations| Contact: Mary Zadnik Newell, ScD, OTR/L | mzadnik@jhsph.edu |
| United States, California | |
| UCSF Medical Center | |
| San Francisco, California, United States, 94115 | |
| United States, Maryland | |
| University of Maryland Medical Center | |
| Baltimore, Maryland, United States, 21201 | |
| United States, North Carolina | |
| Carolinas Medical Center | |
| Charlotte, North Carolina, United States, 28203 | |
| United States, Ohio | |
| MetroHealth Medical Center | |
| Cleveland, Ohio, United States, 44109 | |
| United States, Tennessee | |
| Vanderbilt University Medical Center | |
| Nashville, Tennessee, United States, 37232 | |
| Principal Investigator: | William T Obremskey, MD | Vanderbilt University |
| Principal Investigator: | Renan Castillo, PhD | Johns Hopkins Bloomberg School of Public Health |
More Information
No publications provided
| Responsible Party: | Major Extremity Trauma Research Consortium |
| ClinicalTrials.gov Identifier: | NCT01714596 History of Changes |
| Other Study ID Numbers: | METRC POvIV |
| Study First Received: | April 30, 2012 |
| Last Updated: | October 25, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Major Extremity Trauma Research Consortium:
|
Oral Antibiotic intravenous Antibiotic wound infection Randomized Controlled Trial |
Additional relevant MeSH terms:
|
Wound Infection Infection Wounds and Injuries Anti-Bacterial Agents |
Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013