InfectionsPhase 3POvIV2NCT05699174
PO vs IV Antibiotics for the Treatment of Infected Nonunion of Fractures After Fixation
A Phase 3 study of Infections and Infected Wound, run by Major Extremity Trauma Research Consortium at 13 sites in United States.
Trial summary
This is a Phase III clinical randomized control trial to investigate differences between patient with an infected nonunion treated by PO vs. IV antibiotics. The study population will be 250 patients, 18 years or older, being treated for infected nonunion after internal fixation of a fracture with a segmental defect… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infections, Infected Wound, Nonunion of Fracture
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 13 sitesUnited States
- Study dates
- 30 May 2023to 29 Sep 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Bone fracture (proximal to and including the tarsal/metatarsal joint (Lisfranc) or proximal to the carpal joints (includes distal radius fractures), excluding pelvis and spine) that has previously undergone fixation and has not healed and requires fixation to be retained or replaced at least until bone union. Fractures that have not healed and require revision fixation are also eligible.
- Infection as determined by either
- FRI criteria
- CDC criteria (without the timeframe) This includes the possibility of culture negative, but determined to be infection by treating surgeon
- Systemic antibiotic treatment regimen scheduled for at least 6 weeks
Who cannot join
- Patients with a high risk of amputation based on the initial managing physician
- Patients undergoing treatment of any other investigational therapy within the month preceding infection treatment or planned within the 12 months following infection treatment
- Incarcerated or institutionalized patients
- Patients who are unable to return for required follow-up visits and/or medical co-morbidities which preclude treatment with a general anesthetic
- Patients with a prior history of chronic infection at the index site before fracture fixation
- Patients with pathological fractures from a neoplastic process
Show all 9Show fewer
- History of Paget's Disease
- The patient, or a designated proxy, unwilling to provide consent
- The patient must be available for follow-up for at least 12 months following infection treatment
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Karen Trochez contact
13 sites in 1 country
United States13 sites, 13 recruiting
- Recruiting
University of Maryland , MD Department of Orthopaedics
Baltimore, Maryland, 21201
Yasmin Degani, MPH, ydegani@som.umaryland.edu
Robert O'Toole, MD
- Not yet recruiting
Sinai Hospital Baltimore
Baltimore, Maryland, 21215
Janet Conway, MD
- Not yet recruiting
Atrium Health, Carolinas Medical Center
Charlotte, North Carolina, 28207
Christine Churchill, Christine.Churchill@advocatehealth.org
Madhav Karunakar, MD
- Recruiting
Penn State University M.S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Andrea Myers, BSN, amyers1@pennstatehealth.psu.edu
J. Spence Reid, MD
- Recruiting
University of Texas Health Science Center at Houston
Houston, Texas, 77030
Sterling Boutte, 713-500-6259, Sterling.Boutte@uth.tmc.edu
Warner Stephen, MD
- Recruiting
Indiana University
Indianapolis, Indiana, 46202
Lauren Hill, BS, hilllc@iu.edu
Roman Natoli, MD
- Recruiting
University of Wisconsin
Madison, Wisconsin, 53705
Brittany Grasso, otrc@ortho.wisc.edu
Paul Whiting, MD
- Recruiting
Hennepin Health
Minneapolis, Minnesota, 55487
Olutayo Alese, 612-873-4634, olutayo.alese@hcmed.org
Andrew Schmidt, MD
- Recruiting
Vanderbilt Medical Center
Nashville, Tennessee, 37203
Karen Trochez, karen.m.trochez@vumc.org
William Obremskey, MD
- Not yet recruiting
University of Okalahoma College of Medicine
Oklahoma City, Oklahoma, 73104
Kathy Edge, Kathy-Edge@ou.edu
Brandon Hull, MD
- Not yet recruiting
Jamaica Hospital Medical Center
Queens, New York, 11418
Sanjit Konda, MD
- Recruiting
University of Washington Harborview Medical Center
Seattle, Washington, 98195
Jessica Schisel, jrod24@uw.edu
Michael Githens, MD
- Recruiting
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27106
Martha Holden, Martha.Holden@Advocatehealth.org
Sharon Babock, MD
About this study
Official title: PO Versus IV Antibiotics for the Treatment of Infected Nonunion of Fractures After Fixation
This is a Phase III clinical randomized control trial to investigate differences between patient with an infected nonunion treated by PO vs. IV antibiotics. The study population will be 250 patients, 18 years or older, being treated for infected nonunion after internal fixation of a fracture with a segmental defect less than one centimeter. Patients will be randomly assigned to either the treatment (group 1) PO antibiotics for 6 weeks or the control group (group 2) IV antibiotics for 6 weeks. The primary hypothesis is that the effectiveness of oral antibiotic therapy is equivalent to traditional intravenous antibiotic therapy for the treatment of infected nonunion after fracture internal fixation, when such therapy is combined with appropriate surgical management. Clinical effectiveness will be measured as the primary outcome as the number of secondary re-admissions related to injury and secondary outcomes of treatment failure (re-infection, nonunion, antibiotic complications) within the first one year of follow-up, as defined by specified criteria and determined by a blinded data assessment panel. In addition, treatment compliance, the cost of treatment, the number of surgeries required, the type and incidence of complications, and the duration of hospitalization will be measured.
Read the detailed description
This is a Phase III clinical randomized control trial to investigate differences between patients with infected unhealed fracture treated by PO vs. IV antibiotics. The study population will be 250 patients, 18 years or older, being treated for infected unhealed fracture after internal fixation of a fracture with a segmental defect less than one centimeter. Patients will be randomly assigned to either the treatment (group 1) PO antibiotics for 6 weeks or the control group (group 2) IV antibiotics for 6 weeks. The primary hypothesis is that the effectiveness of oral antibiotic therapy is equivalent to traditional intravenous antibiotic therapy for the treatment of infected unhealed fracture after fracture internal fixation, when such therapy is combined with appropriate surgical management. Clinical effectiveness will be measured as the primary outcome as the number of secondary re-admissions related to injury and secondary outcomes of treatment failure (re-infection, timing of being unhealed, antibiotic complications) within the first one year of follow-up, as defined by specified criteria and determined by a blinded data assessment panel. In addition, treatment compliance, the cost of treatment, the number of surgeries required, the type and incidence of complications, and the duration of hospitalization will be measured.
The specific Aims of this study are to:
Specific Aim 1. Evaluate the effect of treatment of infected fractures that have not yet healed in bone fractures treated with revision fixation and either: (Group 1) operative debridement and PO antibiotic suppression for 6 weeks; or (Group 2) operative debridement and 6 weeks IV antibiotics.
Primary Hypothesis 1a: The rate of re-hospitalization for injury-related complication by one year in Group 1 will be non-inferior to the rate in Group 2.
Hypothesis 1b:. The rate of treatment failure by one year in Group 1 will be non-inferior to the rate in Group 2.
Hypothesis 1c: The rate of persistent infection by one year in Group 1 will be non-inferior to the rate in Group 2.
Hypothesis 1d: The rate of persistent nonunion by one year in Group 1 will be non-inferior to the rate in Group 2.
Hypothesis 1e: The rate of amputation by one year in Group 1 will be non-inferior to the rate in Group 2. Hypothesis 1f: Per patient total costs at 1 year will be lower in Group 1 than in Group 2.
Hypothesis 1g: Compliance in Group 1 will be non-inferior to compliance in Group 2.
Specific Aim 2. Build and validate a risk prediction model for failure of treatment of infected unhealed fractures after fixation of fractures.
Hypothesis 2a: Demographic and injury characteristics will be highly predictive of treatment failure.
Hypothesis 2b: Open fractures will have a higher treatment failure rate than closed fractures.
Hypothesis 2c: Lower extremity fractures will have a higher treatment failure rate than upper extremity fractures.
Hypothesis 2d: Multiple organism infections will have a higher treatment failure rate than single organism infections.
Hypothesis 2e: Gram positive infections will have a higher treatment failure rate than gram negative infections.
Hypothesis 2f: Revision fixation with IMN and treatment failure will be non-inferior to the rate of treatment failure in revision fixation with plates.
Hypothesis 2g: Revision fixation with external fixation and treatment failure will be non-inferior to the rate of treatment failure in revision fixation with IMN or plates.
Hypothesis 2h: One Stage revision fixation strategies will be non-inferior to the rate of treatment failure in Two Staged revision fixation strategies
Study design: At time of treatment for infected and not healed fractures, patients will be randomized to oral (PO) antibiotics group or intravenous (IV) antibiotics group. Patients will receive PO or IV antibiotics for 6 weeks at discharge from the hospitalization to treat the infected unhealed fracture. Both groups will otherwise receive standard care treatment by attending orthopedic surgeon and healthcare team, including debridement and soft tissue coverage of wounds; laboratory evaluation of inflammatory markers at 2 weeks, and 6 weeks; clinical follow at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months to assess recurrence of wound infection; and radiographic follow up at 6 weeks and 3 months or until boney union is confirmed.
Follow-Up: Assessments at baseline and at 2 weeks, 6 weeks, 3 months, 6 months and 12 months following hospital discharge will determine rates of re-hospitalization, treatment failure, infection, nonunion and amputation and patient compliance with antibiotic treatment.
- Conditions
- Infections, Infected Wound, Nonunion of Fracture, Injury Leg, Amputation, Internal Fixation; Complications, Infection or Inflammation
- Being tested
- Standard of Care PO (oral) antibiotics, Standard of Care Intravenous (IV) antibiotics
- Medical subject headings
- Infections, Wound Infection, Fractures, Ununited, Leg Injuries, Inflammation, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of Care PO (oral) antibioticsDrug
An intervention in this study includes randomization of patients with an infected nonunion to PO (oral) antibiotics for up to 6 weeks post hospitalization. The exact type of oral antibiotic will be depended on the patient's infection diagnosis.
Standard of Care Intravenous (IV) antibioticsDrug
An intervention in this study includes randomization of patients with an infected nonunion to intravenous (IV) antibiotics for up to 6 weeks post hospitalization. The exact type of IV antibiotic will be depended on the patient's infection diagnosis.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care PO (oral) antibiotics | Active comparator | An intervention in this study includes randomization of patients with an infected unhealed fracture to standard of care PO (oral) antibiotics for up to 6 weeks post hospitalization. No medications will be provided by the study. Study participants will be prescribed their oral antibiotics by their treating physician and the specific type will depend on their infection diagnosis. Medications will be obtained using health insurance and/or resources available at the treating facility therefore the mode of antibiotics utilized as standard of care will vary across participating sites. Sites will follow their standard of care delivery for antibiotics, and the study will defer to this standard. Receives: Drug: Standard of Care PO (oral) antibiotics |
| Standard of Care Intravenous (IV) antibiotics | Active comparator | An intervention in this study includes randomization of patients with an infected unhealed fracture to intravenous (IV) antibiotics for up to 6 weeks post hospitalization. No medications will be provided by the study. Study participants will be prescribed their IV antibiotics by their treating physician and the specific type will depend on their infection diagnosis. Medications will be obtained using health insurance and/or resources available at the treating facility therefore the mode of antibiotics utilized as standard of care will vary across participating sites. Sites will follow their standard of care delivery for antibiotics, and the study will defer to this standard. Receives: Drug: Standard of Care Intravenous (IV) antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with a hospital re-admission
Total number of re-admissions after revision fixation over the first 365 days post discharge from the hospitalization for initial surgical treatment of the infected nonunion. Re-admission can be for infection, nonunion, soft tissue revision, line complication, or antibiotic complication.
Measured: 1 year
Secondary outcomes (9)
Number of patients with treatment failure
Treatment Failure will define as patients with the following complications:
- Wound problems requiring surgery
- Patients that have culture positive recurrence of infection
- Progressive radiographic loosening of the implant
- Joint erosion due to infection
- Infection with a new organism
- Adverse reactions to any of the antibiotics
- Infection recurrence
- Persistent Nonunion
Measured: 1 year
Number of patients with a re-hospitalization for a complication
Re-hospitalization for Complication is defined as:
- any re-admission to the hospital secondary to the treatment of the deep wound infection associated with the index fracture fixation for a defined set of complications. The list of complications includes: nonunion, amputation, infection, flap failure, , This definition has successfully been used by the core centers in previous published prospective studies and is consistent with the data used to generate the study power estimate.
- any complication of IV access requiring rehospitalization including, but not limited to line sepsis, DVT in same extremity as IV access, pneumothorax, or line change due to malfunction.
Measured: 1 year
Number of patients with an additional infection
Infection will be assessed either as systemic inflammation or surgical site infection.
Measured: 1 year
Number of patients that experienced amputation
Amputation is defined as surgical procedure to remove part of an extremity due to persistent infection or nonunion on proximal to site on affected extremity.
Measured: 1 year
Medical Costs
Medical Costs for the index hospitalization and subsequent hospitalizations (within one year) will be derived using hospital bills and professional fee charges. Costs will be calculated from charges at the revenue center/cost department line level using cost-to-charge ratios (CCRs) computed from the Medicare Cost Reports (MCRs) specific to the hospital and fiscal year of the hospital stay. Of particular interest will be charges and costs associated with the surgical procedures for bone grafting (control and treatment), days hospitalized, and costs for subsequent admissions for complications.
Measured: 1 year
Patient Reported Outcomes
Patient Report Outcomes Measurement Information System Computer Adaptive Test item banks, a product of the NIH Roadmap for Medical Research. CATs present an advantage over traditional measures in that they target only the most relevant items to each patient and can thus be used to obtain precise measurements with 4-6 items, making assessment across multiple domains feasible. CATs can also extend the ceiling and floor of individual domains, potentially enhancing responsiveness. At any visit if a CAT cannot be administered, respondents will instead complete the appropriate short forms associated with the CAT measure. In this study the following PROMIS domains will be used: Physical function, \& Pain Inference in addition to PROMIS Global. Scores are measured on a T-score metric from 0-100 with 50 being the mean and standard deviation of 10 in the general U.S. population. Scores are categorized as: 0-30 severe, 31-40 moderate, 41-50 mild, and 51 and greater within normal limits.
Measured: 1 year
Physical and Psychosocial Function Assessment
Physical and Psychosocial Function Assessment including measurements of symptoms, functioning, and healthcare-related quality of life will be assessed using the Patient-Reported Outcomes Measurement Information System PROMIS Global-10. The PROMIS Global-10 short form consists of 10 items that assess general domains of health and functioning including overall physical health, mental health, social health, pain, fatigue, and overall perceived quality of life. PROMIS Global-10 scoring allows each of the individual items to be examined separately to provide specific information about perceptions of physical function, pain, fatigue, emotional distress, social health and general perceptions of health. Scores are measured on a T-score metric from 0-100 with 50 being the mean and standard deviation of 10 in the general U.S. population. Scores are categorized as: 0-30 severe, 31-40 moderate, 41-50 mild, and 51 and greater within normal limits.
Measured: 1 year
Adherence
Adherence will be measured by the Morisky Medication Adherence Scale (MMAS-8) which is an widely used 8-item expansion of the 4-item Morisky Medication Adherence Scale. The MMAS-8 an 8-item structured, self-report measure that assesses medication adherence. The questions 1-7 require a dichotomous reply and address the common reasons for missing medications. Question 8 is measured using a 5-point Likert scale and addresses difficulty of remembering to take medications. Scores are summed from 0-8 with a 6 or more being considered as adherent to the medications.
Measured: 6 months
Compliance
Compliance will also be measured by percent of doses of medication taken. If less than 80% of doses of any antibiotic medication is taken then patient will be considered non-compliant. Compliance will be evaluated as a continuous variable.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start30 May 2023
- Primary completionSep 2027 (estimated)
- Study completion29 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionsStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two arm, randomized controlled multicenter Phase III trial
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Major Extremity Trauma Research Consortium
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- William Obremskey, MD, Principal investigator, Vanderbilt Medical CenterRenan Castillo, PhD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05699174
- Sponsor's protocol ID
- W81XWH2210635
- Acronym
- POvIV2
- Status last verified
- Jun 2026
- First submitted
- 11 Jan 2023
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PO Versus IV Antibiotics for the Treatment of Infected Nonunion of Fractures After Fixation
- ClinicalTrials.gov ID
- NCT05699174
- Acronym / sponsor ID
- POvIV2 / W81XWH2210635
- Conditions
- Infections, Infected Wound, Nonunion of Fracture, Injury Leg, Amputation, Internal Fixation; Complications, Infection or Inflammation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Major Extremity Trauma Research ConsortiumUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 30 May 2023 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- 29 Sep 2028 (estimated)
- First posted
- 26 Jan 2023 (actual)
- 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.
This is a Phase III clinical randomized control trial to investigate differences between patient with an infected nonunion treated by PO vs. IV antibiotics. The study population will be 250 patients, 18 years or older, being treated for infected nonunion after internal fixation of a fracture with a segmental defect less than one centimeter. Patients will be randomly assigned to either the treatment (group 1) PO antibiotics for 6 weeks or the control group (group 2) IV antibiotics for 6 weeks. The primary hypothesis is that the effectiveness of oral antibiotic therapy is equivalent to traditional intravenous antibiotic therapy for the treatment of infected nonunion after fracture internal fixation, when such therapy is combined with appropriate surgical management. Clinical effectiveness will be measured as the primary outcome as the number of secondary re-admissions related to injury and secondary outcomes of treatment failure (re-infection, nonunion, antibiotic complications) within the first one year of follow-up, as defined by specified criteria and determined by a blinded data assessment panel. In addition, treatment compliance, the cost of treatment, the number of surgeries required, the type and incidence of complications, and the duration of hospitalization will be measured.
Detailed description
This is a Phase III clinical randomized control trial to investigate differences between patients with infected unhealed fracture treated by PO vs. IV antibiotics. The study population will be 250 patients, 18 years or older, being treated for infected unhealed fracture after internal fixation of a fracture with a segmental defect less than one centimeter. Patients will be randomly assigned to either the treatment (group 1) PO antibiotics for 6 weeks or the control group (group 2) IV antibiotics for 6 weeks. The primary hypothesis is that the effectiveness of oral antibiotic therapy is equivalent to traditional intravenous antibiotic therapy for the treatment of infected unhealed fracture after fracture internal fixation, when such therapy is combined with appropriate surgical management. Clinical effectiveness will be measured as the primary outcome as the number of secondary re-admissions related to injury and secondary outcomes of treatment failure (re-infection, timing of being unhealed, antibiotic complications) within the first one year of follow-up, as defined by specified criteria and determined by a blinded data assessment panel. In addition, treatment compliance, the cost of treatment, the number of surgeries required, the type and incidence of complications, and the duration of hospitalization will be measured.
The specific Aims of this study are to:
Specific Aim 1. Evaluate the effect of treatment of infected fractures that have not yet healed in bone fractures treated with revision fixation and either: (Group 1) operative debridement and PO antibiotic suppression for 6 weeks; or (Group 2) operative debridement and 6 weeks IV antibiotics.
Primary Hypothesis 1a: The rate of re-hospitalization for injury-related complication by one year in Group 1 will be non-inferior to the rate in Group 2.
Hypothesis 1b:. The rate of treatment failure by one year in Group 1 will be non-inferior to the rate in Group 2.
Hypothesis 1c: The rate of persistent infection by one year in Group 1 will be non-inferior to the rate in Group 2.
Hypothesis 1d: The rate of persistent nonunion by one year in Group 1 will be non-inferior to the rate in Group 2.
Hypothesis 1e: The rate of amputation by one year in Group 1 will be non-inferior to the rate in Group 2. Hypothesis 1f: Per patient total costs at 1 year will be lower in Group 1 than in Group 2.
Hypothesis 1g: Compliance in Group 1 will be non-inferior to compliance in Group 2.
Specific Aim 2. Build and validate a risk prediction model for failure of treatment of infected unhealed fractures after fixation of fractures.
Hypothesis 2a: Demographic and injury characteristics will be highly predictive of treatment failure.
Hypothesis 2b: Open fractures will have a higher treatment failure rate than closed fractures.
Hypothesis 2c: Lower extremity fractures will have a higher treatment failure rate than upper extremity fractures.
Hypothesis 2d: Multiple organism infections will have a higher treatment failure rate than single organism infections.
Hypothesis 2e: Gram positive infections will have a higher treatment failure rate than gram negative infections.
Hypothesis 2f: Revision fixation with IMN and treatment failure will be non-inferior to the rate of treatment failure in revision fixation with plates.
Hypothesis 2g: Revision fixation with external fixation and treatment failure will be non-inferior to the rate of treatment failure in revision fixation with IMN or plates.
Hypothesis 2h: One Stage revision fixation strategies will be non-inferior to the rate of treatment failure in Two Staged revision fixation strategies
Study design: At time of treatment for infected and not healed fractures, patients will be randomized to oral (PO) antibiotics group or intravenous (IV) antibiotics group. Patients will receive PO or IV antibiotics for 6 weeks at discharge from the hospitalization to treat the infected unhealed fracture. Both groups will otherwise receive standard care treatment by attending orthopedic surgeon and healthcare team, including debridement and soft tissue coverage of wounds; laboratory evaluation of inflammatory markers at 2 weeks, and 6 weeks; clinical follow at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months to assess recurrence of wound infection; and radiographic follow up at 6 weeks and 3 months or until boney union is confirmed.
Follow-Up: Assessments at baseline and at 2 weeks, 6 weeks, 3 months, 6 months and 12 months following hospital discharge will determine rates of re-hospitalization, treatment failure, infection, nonunion and amputation and patient compliance with antibiotic treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two arm, randomized controlled multicenter Phase III trial
| Arm | Type | Receives |
|---|---|---|
| Standard of Care PO (oral) antibiotics | Active comparator | Drug: Standard of Care PO (oral) antibioticsAn intervention in this study includes randomization of patients with an infected unhealed fracture to standard of care PO (oral) antibiotics for up to 6 weeks post hospitalization. No medications will be provided by the study. Study participants will be prescribed their oral antibiotics by their treating physician and the specific type will depend on their infection diagnosis. Medications will be obtained using health insurance and/or resources available at the treating facility therefore the mode of antibiotics utilized as standard of care will vary across participating sites. Sites will follow their standard of care delivery for antibiotics, and the study will defer to this standard. |
| Standard of Care Intravenous (IV) antibiotics | Active comparator | Drug: Standard of Care Intravenous (IV) antibioticsAn intervention in this study includes randomization of patients with an infected unhealed fracture to intravenous (IV) antibiotics for up to 6 weeks post hospitalization. No medications will be provided by the study. Study participants will be prescribed their IV antibiotics by their treating physician and the specific type will depend on their infection diagnosis. Medications will be obtained using health insurance and/or resources available at the treating facility therefore the mode of antibiotics utilized as standard of care will vary across participating sites. Sites will follow their standard of care delivery for antibiotics, and the study will defer to this standard. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1. Bone fracture (proximal to and including the tarsal/metatarsal joint (Lisfranc) or proximal to the carpal joints (includes distal radius fractures), excluding pelvis and spine) that has previously undergone fixation and has not healed and requires fixation to be retained or replaced at least until bone union. Fractures that have not healed and require revision fixation are also eligible.
- Infection as determined by either
- Systemic antibiotic treatment regimen scheduled for at least 6 weeks
Key exclusion criteria (9 listed)
- Patients with a high risk of amputation based on the initial managing physician
- Patients undergoing treatment of any other investigational therapy within the month preceding infection treatment or planned within the 12 months following infection treatment
- Incarcerated or institutionalized patients
- Patients who are unable to return for required follow-up visits and/or medical co-morbidities which preclude treatment with a general anesthetic
- Patients with a prior history of chronic infection at the index site before fracture fixation
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 |
|---|---|---|
| Standard of Care PO (oral) antibioticsAn intervention in this study includes randomization of patients with an infected nonunion to PO (oral) antibiotics for up to 6 weeks post hospitalization. The exact type of oral antibiotic will be depended on the patient's infection diagnosis. | Drug | Standard of Care PO (oral) antibiotics |
| Standard of Care Intravenous (IV) antibioticsAn intervention in this study includes randomization of patients with an infected nonunion to intravenous (IV) antibiotics for up to 6 weeks post hospitalization. The exact type of IV antibiotic will be depended on the patient's infection diagnosis. | Drug | Standard of Care Intravenous (IV) antibiotics |
Primary outcome
Number of patients with a hospital re-admission
Time frame: 1 year
Total number of re-admissions after revision fixation over the first 365 days post discharge from the hospitalization for initial surgical treatment of the infected nonunion. Re-admission can be for infection, nonunion, soft tissue revision, line complication, or antibiotic complication.
9 secondary outcomes
Number of patients with treatment failure
Time frame: 1 year
Number of patients with a re-hospitalization for a complication
Time frame: 1 year
Number of patients with an additional infection
Time frame: 1 year
Number of patients that experienced amputation
Time frame: 1 year
Medical Costs
Time frame: 1 year
Patient Reported Outcomes
Time frame: 1 year
Physical and Psychosocial Function Assessment
Time frame: 1 year
Adherence
Time frame: 6 months
Compliance
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Karen Trochez contact
William Obremskey, MD principal investigator
Vanderbilt Medical Center
Renan Castillo, PhD principal investigator
Johns Hopkins Bloomberg School of Public Health
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Infections and Infected Wound, run by Major Extremity Trauma Research Consortium at 13 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 5 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact William Obremskey, MD (615-260-2054, william.obremskey@vumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with a hospital re-admission (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Sep 2026.