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Anti-bacterial
Oral Antibiotics for Prosthetic Joint Infections
Phase 4
Waitlist Available
Led By Nicholas Bedard, MD
Research Sponsored by University of Iowa
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient is a candidate for elective, primary total hip arthroplasties (THA) or total knee arthroplasties (TKA).
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 1-year of primary hip or knee arthroplasty
Awards & highlights
Study Summary
This trial is testing whether a 7-day course of an oral, prophylactic antibiotic can reduce the incidence of periprosthetic joint infection and wound complications following primary total hip and knee arthroplasty in a high-risk patient population.
Who is the study for?
This trial is for adults needing a first-time hip or knee replacement who are at high risk of infection due to obesity, diabetes, smoking, kidney disease, autoimmune conditions, or nasal colonization with Staphylococcus bacteria. It's not for those allergic to the study antibiotics, unable to take oral meds, pregnant women, or patients planning other joint replacements soon.Check my eligibility
What is being tested?
The trial tests if taking an antibiotic (Cephalexin, Doxycycline or Cefadroxil) for 7 days can prevent infections and wound issues after hip or knee replacement surgery in high-risk patients. Participants will receive one of these antibiotics as a preventative measure.See study design
What are the potential side effects?
Possible side effects from the antibiotics may include stomach upset like diarrhea and nausea; allergic reactions such as rashes; and less commonly yeast infections. Serious side effects are rare but could involve severe allergies.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for a first-time hip or knee replacement surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 1-year of primary hip or knee arthroplasty
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 1-year of primary hip or knee arthroplasty
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Communicable Diseases
Secondary outcome measures
Wound complication
Trial Design
2Treatment groups
Active Control
Group I: Additional Antibiotic GroupActive Control3 Interventions
Patients will receive an oral antibiotic to be started after completion of standard perioperative antibiotics following primary hip or knee arthroplasty. Oral antibiotic will either be a first-generation cephalosporin (Cefadroxil or Cephalexin) or Doxycycline based upon patient allergies, kidney function and result of nasal colonization testing for MRSA.
Group II: Control Group - No Additional AntibioticActive Control1 Intervention
Patients will receive standard perioperative antibiotics following primary hip or knee arthroplasty and no additional antibiotics.
Find a Location
Who is running the clinical trial?
University of IowaLead Sponsor
454 Previous Clinical Trials
877,420 Total Patients Enrolled
Mayo ClinicLead Sponsor
3,239 Previous Clinical Trials
3,766,981 Total Patients Enrolled
1 Trials studying Prosthetic Joint Infections
Nicholas Bedard, MDPrincipal Investigator - Mayo Clinic
University of Iowa
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am having or have had a hip or knee replacement redone.I am allergic to certain antibiotics listed in the treatment plan.I have had a partial joint replacement.I have had clostridium difficile colitis in the past.I will have a hip or knee replacement within the next 12 weeks.I am having or have had both hips or knees replaced at the same time.I have had surgery that was not planned in advance.I am scheduled for a first-time hip or knee replacement surgery.I have had a partial knee replacement.I am at high risk for joint infections due to one or more health issues.
Research Study Groups:
This trial has the following groups:- Group 1: Additional Antibiotic Group
- Group 2: Control Group - No Additional Antibiotic
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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