Antibiotic Prophylaxis in High-Risk Arthroplasty Patients

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
Mayo Clinic
Study ID
NCT04297592
Phase
PHASE4
Status
Enrolling By Invitation

Conditions

  • Autoimmune Diseases
  • Chronic Kidney Diseases
  • Diabetes
  • Infections Joint Prosthetic
  • Inflammatory Disease
  • MRSA
  • MSSA Colonization
  • Overweight or Obesity
  • Tobacco Use

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Cephalexin — DRUG
    500 mg oral tablet, 4 times daily for 7 days
  • Doxycycline — DRUG
    100 mg oral tablet, 2 times daily for 7 days
  • Cefadroxil — DRUG
    500 mg oral tablet, 2 times daily for 7 days

Study Details

To determine the effectiveness of a 7-day course of an oral, prophylactic antibiotic on the incidence of periprosthetic joint infection and wound complications following primary total hip and knee arthroplasty in a high-risk patient population.

Key Dates

Start date
Jun 11, 2020
Status verified
Jun 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
4,618 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Additional Antibiotic Group
    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.
  • No Intervention: Control Group - No Additional Antibiotic
    Patients will receive standard perioperative antibiotics following primary hip or knee arthroplasty and no additional antibiotics.

Primary Outcome Measure

Periprosthetic joint infections [ Time Frame: Within 90-days primary hip or knee arthroplasty ]

Locations (2)

FacilityCityStateZIPSite coordinators
University of Iowa Hospitals & ClinicsIowa CityIowa52242-
Mayo ClinicRochesterMinnesota55902-

Find similar trials in Iowa City, IA

By research site
University of Iowa Hospitals & Clinics· Iowa City, IAMayo Clinic· Rochester, MN

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