Randomized Trial to Assess PO Versus IV Antibiotics

Wound Infection Clinical Trial

— POvIV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01714596
• Other study ID #: METRC POvIV
• Status: Completed
• Phase: N/A
• Start date: December 3, 2013
• Est. completion date: December 30, 2020

Study information

• Verified date: February 2021
• Source: Major Extremity Trauma Research Consortium
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 233
• Est. completion date: December 30, 2020
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 84 Years

Eligibility

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).

Related Conditions & MeSH terms

• Infection
• Wound Infection

Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Major Extremity Trauma Research Consortium

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study injury related surgical interventions by 1 year		1 year
Secondary	Treatment Failure by 1 year	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.	1 year
Secondary	Re-hospitalizations by 1 year	Re-hospitalization for complications, such as infection, non-union and amputation	1 year
Secondary	Healthcare costs	Cost of PO versus IV medications include medical record and bill abstracted costs associated with outpatient clinic visits, home health visits, medication, subsequent hospital readmission, and other types of medical care as identified over the course of the study.	1 year
Secondary	Medication Adherence	Patient adherence to PO and IV medications; Patient adherence with PO antibiotics will be monitored through wireless-enabled microchip monitors embedded in pill bottles by the Medication Event Monitoring System (MEMS) and weekly adherence questionnaire.	1 year
Secondary	Satisfaction with treatment	Patient satisfaction with treatment measured by Short Form Patient Satisfaction Questionnaire (PSQ-18); The PSQ-18 measures 6 domains: technical quality, interpersonal manner, communication, financial aspects of care, time spent with doctor, and accessibility. A score of 0.8 or higher in each domain correlates with improved satisfaction.	1 year