Wound InfectionPOvIVNCT01714596
Randomized Trial to Assess PO Versus IV Antibiotics
A study testing PO versus IV antibiotics Route of administration evaluation in people with Wound Infection, run by Major Extremity Trauma Research Consortium at 24 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Wound Infection
- What is being tested?
- PO versus IV antibiotics Route of administration evaluation
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 233 participants
- Where
- 24 sitesUnited States
- Study dates
- 3 Dec 2013to 30 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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.
- Patients diagnosed with a wound infection of the study injury, defined as patients with at least one of the following:
- Deep culture positive after operative debridement.
- Cultures positive in thio only after operative debridement.
- Negative culture after operative debridement if wound infection meets the Center for Disease control and Prevention (CDC) criteria.
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- 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 temporary external fixation prior to definitive fixation.
- Patients may have received antibiotics prior to operative wound debridement.
- Patient is able to obtain study medication(s).
- Patient may be pregnant at the time of screening.
Who cannot join
- 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 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.
- 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.
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- Patients who are currently on Selective Serotonin Reuptake Inhibitor (SSRI) medication (e.g. Zoloft, Prozac, Celexa), and bacteria is MRSA
- 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).
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United States24 sites
University of Maryland R Adams Cowley Shock Trauma Center
Baltimore, Maryland
University of Alabama at Birmingham
Birmingham, Alabama
Boston Medical Center
Boston, Massachusetts
Carolinas Medical Center
Charlotte, North Carolina
University of Virginia
Charlottesville, Virginia
MetroHealth Medical Center
Cleveland, Ohio
Denver Health and Hospital Authority
Denver, Colorado
Inova Fairfax Hospital
Falls Church, Virginia
Penn State University M.S. Hershey Medical Center
Hershey, Pennsylvania
Eskenazi Health
Indianapolis, Indiana
University of Iowa Hospitals & Clinics
Iowa City, Iowa
Jamaica Hospital Medical Center
Jamaica, New York
Cedars Sinai Medical Center
Los Angeles, California
University of Wisconsin
Madison, Wisconsin
University of Miami Ryder Trauma Center
Miami, Florida
Hennepin County Medical Center
Minneapolis, Minnesota
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
NYU Langone Medical Center
New York, New York
Naval Medical Center Portsmouth
Portsmouth, Virginia
San Antonio Military Medical Center (SAMMC)
San Antonio, Texas
University of California at San Francisco
San Francisco, California
University of Washington/Harborview Medical Center
Seattle, Washington
St. Louis University Medical Center
St Louis, Missouri
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina
About this study
Official title: 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 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.
Read more
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.
- Conditions
- Wound Infection
- Being tested
- PO versus IV antibiotics Route of administration evaluation
- Keywords
- Oral Antibiotic, Intravenous Antibiotic, Wound infection, Randomized Controlled Trial
- Medical subject headings
- Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PO versus IV antibiotics Route of administration evaluationOther
Also called based on local practices and bacterial susceptibilities
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.
| Study group | Role | What they receive |
|---|---|---|
| Oral Antibiotic | Active comparator | Oral Antibiotic Arm; Participants assigned to this group will receive oral antibiotics as prescribed by their treating physician. Receives: Other: PO versus IV antibiotics Route of administration evaluation |
| IV Antibiotic | Active comparator | Participants assigned to this group will receive intravenous (IV) antibiotics as prescribed by their treating physician. Receives: Other: PO versus IV antibiotics Route of administration evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study injury related surgical interventions by 1 year
Measured: 1 year
Secondary outcomes (5)
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.
Measured: 1 year
Re-hospitalizations by 1 year
Re-hospitalization for complications, such as infection, non-union and amputation
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2012 (estimated)
- Study start3 Dec 2013
- Primary completion30 Sep 2019
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Wound InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 233 participants (actual)
Sponsor and investigators
- Lead sponsor
- Major Extremity Trauma Research Consortium
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William T Obremskey, MD, Principal investigator, Vanderbilt University Medical CenterRenan Castillo, PhD, Principal investigator, Johns Hopkins Bloomberg School of Public HealthTara Taylor, MPH, Study director, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01714596
- Sponsor's protocol ID
- METRC POvIV
- Acronym
- POvIV
- Status last verified
- Feb 2021
- First submitted
- 30 Apr 2012
- Last updated
- 11 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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, Egol KA, 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, Whiting PS, Haleem A, Domes C, Lang GJ, Kuhn GR, Archer KR, Talbot T, Burgos EJ, Gajari V, Herrera LN, Rodriguez-Buitrago A, Tummuru RR, Abraham CM, 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.
PubMed 39841468
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Trial to Assess PO Versus IV Antibiotics for the Treatment of Post-op Wound Infection After Extremity Fractures (POvIV)
- ClinicalTrials.gov ID
- NCT01714596
- Acronym / sponsor ID
- POvIV / METRC POvIV
- Conditions
- Wound Infection
- Keywords
- Oral Antibiotic, Intravenous Antibiotic, Wound infection, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 233 participants (actual)
- Lead sponsor
- Major Extremity Trauma Research ConsortiumUniversity, hospital or other
- Study start
- 3 Dec 2013 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 26 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Antibiotic | Active comparator | Other: PO versus IV antibiotics Route of administration evaluationOral Antibiotic Arm; Participants assigned to this group will receive oral antibiotics as prescribed by their treating physician. |
| IV Antibiotic | Active comparator | Other: PO versus IV antibiotics Route of administration evaluationParticipants assigned to this group will receive intravenous (IV) antibiotics as prescribed by their treating physician. |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
- 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.
- Patients diagnosed with a wound infection of the study injury, defined as patients with at least one of the following:
- Patients who are English or Spanish competent.
- Patients aged 18 - 84.
Key exclusion criteria (15 listed)
- 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 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.
- Patients with pathological fractures; a known history of Paget's disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PO versus IV antibiotics Route of administration evaluationAlso: based on local practices and bacterial susceptibilitiesThis 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 | IV Antibiotic, Oral Antibiotic |
Primary outcome
Study injury related surgical interventions by 1 year
Time frame: 1 year
5 secondary outcomes
Treatment Failure by 1 year
Time frame: 1 year
Re-hospitalizations by 1 year
Time frame: 1 year
Healthcare costs
Time frame: 1 year
Medication Adherence
Time frame: 1 year
Satisfaction with treatment
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
- Derived from this study: PubMed 39841468Major 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, Egol KA, 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, Whiting PS, Haleem A, Domes C, Lang GJ, Kuhn GR, Archer KR, Talbot T, Burgos EJ, Gajari V, Herrera LN, Rodriguez-Buitrago A, Tummuru RR, Abraham CM, 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William T Obremskey, MD principal investigator
Vanderbilt University Medical Center
Renan Castillo, PhD principal investigator
Johns Hopkins Bloomberg School of Public Health
Tara Taylor, MPH study director
Johns Hopkins Bloomberg School of Public Health
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PO versus IV antibiotics Route of administration evaluation in people with Wound Infection, run by Major Extremity Trauma Research Consortium at 24 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study injury related surgical interventions by 1 year (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01714596, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2021.