Group A - antibiotic group for Prosthetic Joint Infections

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Prosthetic Joint Infections+8 MoreCephalexin Oral Tablet - Drug
Eligibility
18 - 99
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Prosthetic Joint Infections
  • Chronic Kidney Disease
  • Tobacco Use
  • Overweight or Obesity
  • Methicillin-susceptible Staphylococcus aureus Colonization
  • Methicillin-resistant Staphylococcus aureus
  • Diabetes
  • Inflammatory Diseases
  • Autoimmune Diseases

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: Within 1-year of primary hip or knee arthroplasty

Within 1-year of primary hip or knee arthroplasty
Communicable Diseases
Day 90
Wound complication

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Group B - no additional antibiotic
1 of 2
Group A - antibiotic group
1 of 2

Active Control

956 Total Participants · 2 Treatment Groups

Primary Treatment: Group A - antibiotic group · No Placebo Group · Phase 4

Group B - no additional antibioticNoIntervention Group · 1 Intervention: Group B - no additional antibiotic · Intervention Types:
Group A - antibiotic groupActiveComparator Group · 2 Interventions: Cephalexin Oral Tablet, Doxycycline Hyclate · Intervention Types: Drug, Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: within 1-year of primary hip or knee arthroplasty

Who is running the clinical trial?

University of IowaLead Sponsor
410 Previous Clinical Trials
874,973 Total Patients Enrolled
Nicholas Bedard, MDPrincipal InvestigatorUniversity of Iowa Hospitals & Clinics
Jacob Elkins, MDPrincipal InvestigatorUniversity of Iowa Hospitals & Clinics

Eligibility Criteria

Age 18 - 99 · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are between the ages of 18-99.
You are undergoing elective, primary total hip or total knee arthroplasty.
You have one or more of the following high risk criteria: BMI > 35 kg/m^2, diagnosis of diabetes, active tobacco user, chronic kidney disease (estimated glomerular filtration < 60 mL/min/1.