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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Major Extremity Trauma Research Consortium
Sponsor:
Information provided by (Responsible Party):
Major Extremity Trauma Research Consortium
ClinicalTrials.gov Identifier:
NCT01714596
First received: April 30, 2012
Last updated: December 4, 2013
Last verified: December 2013
  Purpose

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.


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 Extremity Fractures (POvIV)

Resource links provided by NLM:


Further study details as provided by Major Extremity Trauma Research Consortium:

Primary Outcome Measures:
  • Primary objective: investigate the efficacy of oral (PO) antibiotic therapy versus intravenous (IV) antibiotics in the treatment of acute infection after fixation of fractures or joint fusions. [ 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.


Secondary Outcome Measures:
  • 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 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 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 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 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
Criteria

Inclusion Criteria:

  1. Patients with fractures (defined as femurs, tibias, and fibulas of the legs, and the humeri, radii, and ulnas of the arms) treated with a plate or IMN, or
  2. Patients undergoing fusion of subtalar, ankle, knee, wrist or elbow that develop a post op wound infection.
  3. Patients diagnosed with a wound infection of the study injury, defined as deep culture positive after operative debridement
  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 prior history of infection at the site of study injury.
  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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01714596

Contacts
Contact: Mary Zadnik Newell, ScD, OTR/L mzadnik@jhsph.edu

Locations
United States, California
UCSF Medical Center Recruiting
San Francisco, California, United States, 94115
Principal Investigator: Theodore Miclau, MD         
United States, Maryland
University of Maryland Medical Center Recruiting
Baltimore, Maryland, United States, 21201
Principal Investigator: Andrew Pollack, MD         
United States, North Carolina
Carolinas Medical Center Recruiting
Charlotte, North Carolina, United States, 28203
Principal Investigator: Michael J Bossee, MD         
United States, Ohio
MetroHealth Medical Center Recruiting
Cleveland, Ohio, United States, 44109
Principal Investigator: Heather A Vallier, MD         
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Principal Investigator: William T. Obremskey, MD, MPH         
Sponsors and Collaborators
Major Extremity Trauma Research Consortium
Investigators
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: December 4, 2013
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:
Anti-Bacterial Agents
Antibiotics, Antitubercular
Communicable Diseases
Infection
Surgical Wound Infection
Wound Infection
Pathologic Processes
Postoperative Complications
Wounds and Injuries
Anti-Infective Agents
Antitubercular Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014