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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).
Patient is considered high-risk for developing Periprosthetic joint infections (PJI) based on having at least one of the following criteria: Body mass index (BMI) > 35 kg/m^2, Diagnosis of diabetes mellitus, Active tobacco smoker, Chronic kidney disease, Autoimmune disease, Nasal colonization with methicillin-resistant Staphylococcus aureus (MRSA) or methicillin-sensitive Staphylococcus aureus (MSSA).
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 below
Select...
I am scheduled for a first-time hip or knee replacement surgery.
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I am at high risk for joint infections due to one or more health issues.

Timeline

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

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
443 Previous Clinical Trials
874,072 Total Patients Enrolled
Mayo ClinicLead Sponsor
3,176 Previous Clinical Trials
3,753,433 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what bacterial infections is Group A antibiotic typically prescribed?

"Group A - antibiotic is typically utilised to combat severe acne flare-ups, but can also prove efficacious against certain bacterial infections such as trachoma and Klebsiella."

Answered by AI

What assessment has been conducted to review the safety of Group A antibiotics for human use?

"Extensive clinical data supports the safety of Group A - antibiotic group, so it was awarded a score 3."

Answered by AI

What are the current venues in which this experiment is being conducted?

"Currently, 4 medical sites are enrolling individuals for this trial. These locations include Morgantown, Iowa City and Rochester as well as other nearby spots. It is best to select a clinic close by in order to minimize travelling needs while taking part in the study."

Answered by AI

Does this experiment accept participants aged 55 and above?

"This trial has established the age range of 18 to 99 as its criteria for eligibility. For those below 18, there are 154 trials available and 919 studies for individuals above 65 years old."

Answered by AI

Would I be eligible to join the experiment?

"This medical study seeks to recruit 956 individuals aged 18-99, who are undergoing elective primary total hip or knee arthroplasty. Applicants should also meet these additional criteria: BMI over 35kg/m^2, diagnosis of diabetes mellitus, actively using tobacco products, chronic kidney disease (eGFR lower than 60 mL/min/1.73 m2), nasal colonization by MRSA and MSSA bacteria; autoimmune or inflammatory illnesses."

Answered by AI

How many participants are currently selected for this research program?

"That is accurate. Per information hosted on clinicaltrials.gov, this medical trial first appeared on June 11th 2020 and was recently updated December 27 2021. The study necessitates 956 participants recruited from 4 distinct sites in order to be completed successfully."

Answered by AI

What other investigations have been performed with Group A - antibiotic cohort?

"Group A - antibiotic group has been the subject of 192 completed trials since its original study at The Univeristy Hospital in 2010, with 51 active studies being conducted primarily out of Morgantown, West virginia."

Answered by AI

Are there any opportunities for people to join the research project at this time?

"Affirmative, the info hosted on clinicaltrials.gov reveals that this medical study is currently seeking volunteers. This trial was first published on June 11th 2020 and recently updated December 27th 2021; it requires 956 patients from 4 distinct sites to participate."

Answered by AI
Recent research and studies
~1096 spots leftby Jun 2025