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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
Must not have
Revision hip or knee arthroplasty procedure.
Allergy to antibiotic alternatives in the protocol.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 90-days primary hip or knee arthroplasty
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

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.
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.
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 below
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I am scheduled for a first-time hip or knee replacement surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am having or have had a hip or knee replacement redone.
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I am allergic to certain antibiotics listed in the treatment plan.
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I have had clostridium difficile colitis in the past.
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I am having or have had both hips or knees replaced at the same time.
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I have had surgery that was not planned in advance.
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I have had a partial knee replacement.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 90-days primary hip or knee arthroplasty
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 90-days primary hip or knee arthroplasty for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Communicable Diseases
Secondary study objectives
Wound complication

Awards & Highlights

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.

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
465 Previous Clinical Trials
888,653 Total Patients Enrolled
Mayo ClinicLead Sponsor
3,326 Previous Clinical Trials
3,054,864 Total Patients Enrolled
1 Trials studying Prosthetic Joint Infections
Nicholas Bedard, MDPrincipal Investigator - Mayo Clinic
University of Iowa

Media Library

Cephalexin Oral Tablet (Anti-bacterial) Clinical Trial Eligibility Overview. Trial Name: NCT04297592 — Phase 4
Prosthetic Joint Infections Research Study Groups: Additional Antibiotic Group, Control Group - No Additional Antibiotic
Prosthetic Joint Infections Clinical Trial 2023: Cephalexin Oral Tablet Highlights & Side Effects. Trial Name: NCT04297592 — Phase 4
Cephalexin Oral Tablet (Anti-bacterial) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04297592 — Phase 4
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