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Antibiotic

Standard of Care Intravenous (IV) antibiotics for Amputation (POvIV2 Trial)

Phase 3
Recruiting
Led By William Obremskey, MD
Research Sponsored by Major Extremity Trauma Research Consortium
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

POvIV2 Trial Summary

This trial will study 250 adults with an infected bone fracture that is not healing properly. Patients will be randomly given either oral antibiotics or intravenous antibiotics for 6 weeks to see if there is a

Who is the study for?
This trial is for adults over 18 with infected nonunion fractures after internal fixation, which haven't healed properly despite previous surgery. Participants must need at least 6 weeks of antibiotics and meet specific infection criteria. Those not fitting this description or having other conditions that could interfere with the study are excluded.Check my eligibility
What is being tested?
The trial compares oral (PO) versus intravenous (IV) antibiotics in treating infected nonunion fractures after surgical bone repair. It aims to determine if taking pills is as effective as IV treatment when combined with proper surgery. Outcomes include re-admission rates, treatment failure, complications within a year, and overall costs.See study design
What are the potential side effects?
Potential side effects from both PO and IV antibiotics may include allergic reactions, gastrointestinal issues like nausea or diarrhea, possible organ toxicity depending on the antibiotic used, and increased risk of secondary infections such as Clostridium difficile.

POvIV2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of patients with a hospital re-admission
Secondary outcome measures
Adherence
Compliance
Medical Costs
+6 more

POvIV2 Trial Design

2Treatment groups
Active Control
Group I: Standard of Care Intravenous (IV) antibioticsActive Control1 Intervention
An intervention in this study includes randomization of patients with an infected nonunion 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.
Group II: Standard of Care PO (oral) antibioticsActive Control1 Intervention
An intervention in this study includes randomization of patients with an infected nonunion 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.

Find a Location

Who is running the clinical trial?

United States Department of DefenseFED
865 Previous Clinical Trials
327,449 Total Patients Enrolled
Major Extremity Trauma Research ConsortiumLead Sponsor
31 Previous Clinical Trials
27,128 Total Patients Enrolled
William Obremskey, MDPrincipal InvestigatorVanderbilt Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

At how many distinct sites is this research study currently being overseen?

"Hennepin Health in Minneapolis, Minnesota; Atrium Health, Carolinas Medical Center in Charlotte, North carolina; and NYU Langone Medical Center in New york City are among the 11 diverse locations hosting this clinical trial."

Answered by AI

Is the recruitment phase for this medical study currently ongoing?

"As per clinicaltrials.gov, this ongoing trial is currently open for patient enrollment. The study was initially listed on 5/30/2023 and most recently revised on 3/26/2024."

Answered by AI

What is the total number of participants being recruited for this clinical study?

"Yes, the details on clinicaltrials.gov confirm that this investigation is presently seeking volunteers. Initially shared on May 30th, 2023, and last revised on March 26th, 2024, enrollment for this research involves finding 250 participants distributed among 11 locations."

Answered by AI

Has the FDA sanctioned the use of intravenous antibiotics as the accepted standard treatment?

"Based on our assessment, the safety rating for Standard of Care Intravenous (IV) antibiotics is graded at 3 out of a possible score due to it being in Phase 3 trial with established efficacy and extensive safety data."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
PO vs IV Antibiotics for the Treatment of Infected Nonunion of Fractures After Fixation
2023. "PO vs IV Antibiotics for the Treatment of Infected Nonunion of Fractures After Fixation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05699174.
All > Infectious Disease
~139 spots leftby Sep 2025
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