Oral vs IV Antibiotics for Infected Broken Bones (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

No Placebo-Only Group

Pivotal 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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of patients with a hospital re-admission

Secondary study objectives

Adherence

Compliance

Medical Costs

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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.

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