Oral vs IV Antibiotics for Infected Broken Bones
(POvIV2 Trial)
Recruiting in Palo Alto (17 mi)
+10 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Major Extremity Trauma Research Consortium
Must be taking: Antibiotics
Disqualifiers: Amputation risk, Investigational therapy, Incarceration, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of oral versus intravenous antibiotics for treating infected broken bones?
Research shows that oral antibiotics can be as effective as intravenous antibiotics for bone and joint infections, with similar cure rates observed in conditions like osteomyelitis (a bone infection). This suggests that oral antibiotics might work just as well for treating infected broken bones.
12345Is it safe to use oral antibiotics instead of intravenous antibiotics for treating infections?
Research suggests that oral antibiotics can be a safe alternative to intravenous antibiotics for certain infections, as they have been shown to achieve safe levels in the body and are generally well-tolerated. Studies indicate that oral antibiotics may have fewer complications compared to intravenous ones, and they are considered safe for use in stable patients.
46789How do oral and intravenous antibiotics differ for treating infected broken bones?
This treatment is unique because it compares oral antibiotics, which are taken by mouth, to intravenous antibiotics, which are given through a vein, for treating infected broken bones. Research suggests that oral antibiotics can be just as effective as intravenous ones, offering a more convenient option without compromising outcomes.
124510Eligibility Criteria
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.Inclusion Criteria
My broken bone hasn't healed properly after surgery and it's been over 3 months.
I have an infection confirmed by a doctor and am on antibiotics for 6+ weeks.
Exclusion Criteria
Patients with a high risk of amputation based on the initial managing physician
Incarcerated or institutionalized patients
Patients with a prior history of chronic infection at the index site before fracture fixation
+6 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either oral (PO) or intravenous (IV) antibiotics for 6 weeks post hospitalization for infected nonunion
6 weeks
Visits at 2 weeks and 6 weeks for laboratory evaluation and clinical follow-up
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments for re-hospitalization, treatment failure, infection, nonunion, and amputation
12 months
Follow-up visits at 3 months, 6 months, and 12 months
Participant Groups
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.
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 Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Washington Harborview Medical CenterSeattle, WA
Atrium Health, Carolinas Medical CenterCharlotte, NC
University of Texas Health Science Center at HoustonHouston, TX
Indiana UniversityIndianapolis, IN
More Trial Locations
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Who Is Running the Clinical Trial?
Major Extremity Trauma Research ConsortiumLead Sponsor
United States Department of DefenseCollaborator
References
Oral versus intravenous antibiotics for bone and joint infections: the OVIVA non-inferiority RCT. [2021]Management of bone and joint infection commonly includes 4-6 weeks of intravenous (IV) antibiotics, but there is little evidence to suggest that oral (PO) therapy results in worse outcomes.
Oral versus Intravenous Antibiotics for Bone and Joint Infection. [2022]The management of complex orthopedic infections usually includes a prolonged course of intravenous antibiotic agents. We investigated whether oral antibiotic therapy is noninferior to intravenous antibiotic therapy for this indication.
Oral antibiotics at discharge for children with acute osteomyelitis: a rapid cycle improvement project. [2021]Substantial evidence demonstrates comparable cure rates for oral versus intravenous therapy for routine osteomyelitis. Evidence adoption is often slow and in our centre virtually all patients with osteomyelitis were discharged on intravenous therapy.
Intravenous versus oral outpatient antibiotic therapy for pediatric acute osteomyelitis. [2021]The optimal route (oral versus intravenous) of antibiotic administration for pediatric acute osteomyelitis is not well established. Seventy-eight children from our university hospital and 17 children at our county hospital were treated for acute osteomyelitis. The rates of intravenous antibiotics upon discharge were 95% versus 65% (P=0.002), respectively. The recurrence rate and line complication rates were 10% and 24% at the university hospital, compared to 0% (P=0.34) and 6% (P=0.29) at the county hospital. Based on this data, a prospective comparison between intravenous and early oral antibiotic therapy for pediatric acute osteomyelitis is recommended.
Oral vs. intravenous empirical antimicrobial therapy in febrile neutropenic patients receiving childhood cancer chemotherapy. [2020]To compare the use of intravenous vs. oral antibiotic therapy.
Oral antibiotics for infective endocarditis: a clinical review. [2021]Current guidelines for management of infective endocarditis (IE) advise 4-6 weeks of IV antibiotics. This is based on historical data from animal models, which set a precedent for high peak serum antimicrobial levels, thought to be only achievable with IV therapy. However, there has been increasing recent interest in oral antibiotics as an alternative to prolonged parenteral therapy, not limited to treatment of IE. This review examines the theory behind parenteral antibiotic administration with reference to the MICs of relevant pathogens. By comparing published serum antimicrobial levels after oral and IV administration we suggest that safe levels of commonly used antibiotics can be achieved orally. We have then reviewed the literature to date on oral antibiotics for IE. The largest randomized controlled trial (RCT) in this area, the POET trial, concluded that oral therapy was non-inferior to prolonged IV therapy in stable patients with left-sided IE. Additionally, there have been two smaller RCTs published, as well as a number of observational studies over the last 50 years, utilizing a variety of different patient groups, methods and treatment strategies. This body of evidence gives weight to a potential shift in practice towards oral therapy, primarily as a step-down treatment. We conclude that pharmacological data offer theoretical reassurance for the safety of oral therapy. This is coupled with a growing evidence base for non-inferiority of oral antimicrobials compared with prolonged parenteral therapy in practice.
Development of operationalized intravenous to oral antibiotic switch criteria. [2022]Despite huge overlap in suggested criteria for a safe intravenous (iv)-to-oral antibiotic switch, there is considerable variation in their operationalization. The objective of this study was to develop a set of measurable conditions that should be met in adult hospitalized patients for a safe iv-to-oral switch.
Intravenous versus intravenous/oral antibiotics for perforated appendicitis in pediatric patients: a systematic review and meta-analysis. [2020]The use of oral (PO) antibiotics following a course of certain intravenous (IV) antibiotics is proposed in order to avoid the complications of IV medications and to decrease the cost. However, the efficacy and safety of sequential IV/PO antibiotics is unclear and requires further study.
Comparison of adverse events between oral and intravenous formulations of antimicrobial agents: a systematic review of the evidence from randomized trials. [2018]Some clinicians may favor a strategy of early switch to oral antimicrobial therapy for patients responding to initial intravenous therapy. An important relevant consideration refers to the comparative safety and tolerability between oral and intravenous antimicrobial therapy. LITERATURE SEARCH/STUDY SELECTION: We sought to evaluate the above-mentioned issue by performing a systematic review of randomized studies comparing the occurrence of adverse events between oral and intravenous antimicrobial therapy with the same agents.
Clinical Experience of Implementing Oral Versus Intravenous Antibiotics (OVIVA) in a Specialist Orthopedic Hospital. [2021]The Oral Versus Intravenous Antibiotics (OVIVA) Trial demonstrated that oral therapy, when used during the initial 6 weeks in the treatment in bone and joint infection (BJI), is noninferior to intravenous therapy. To date there are no reports describing reproducibility of these findings in a real-world setting.