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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 1-year of 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 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

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 1-year of 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.

0 / 7Eligibility criteria met