Antibiotic Prophylaxis in High-Risk Arthroplasty Patients

NCT04297592 | Enrolling By Invitation Phase 4 FDA Drug

• 1 other identifier: 22-001273
• Study Type: interventional
• Target: 4,618
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

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

Keywords

total hip arthroplasty; total knee arthroplasty; hip replacement; knee replacement; periprosthetic joint infection; prophylaxis; antibiotics

Outcome Measures

Primary Outcomes (2)

• Periprosthetic joint infections

  Defined by Musculoskeletal Infection Society (MSIS) criteria

  Within 90-days primary hip or knee arthroplasty

• Periprosthetic joint infections

  Defined by Musculoskeletal Infection Society (MSIS) criteria

  Within 1-year of primary hip or knee arthroplasty

Secondary Outcomes (1)

• Wound complication

  Within 90 days of primary hip or knee arthroplasty

Study Arms (2)

Additional Antibiotic Group

ACTIVE COMPARATOR

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.

Drug: Cephalexin; Drug: Doxycycline; Drug: Cefadroxil

Control Group - No Additional Antibiotic

NO INTERVENTION

Patients will receive standard perioperative antibiotics following primary hip or knee arthroplasty and no additional antibiotics.

Interventions

Cephalexin DRUG

500 mg oral tablet, 4 times daily for 7 days

Also known as: Keflex

Additional Antibiotic Group

Doxycycline DRUG

100 mg oral tablet, 2 times daily for 7 days

Additional Antibiotic Group

Cefadroxil DRUG

500 mg oral tablet, 2 times daily for 7 days

Also known as: Duricef

Additional Antibiotic Group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Inability to consume oral antibiotics.
• Allergy to antibiotic alternatives in the protocol.
• History of clostridium difficile colitis.
• Revision hip or knee arthroplasty procedure.
• Non-elective surgery.
• Hemiarthroplasty.
• Unicompartmental knee arthroplasty.
• Simultaneous bilateral THA or TKA.
• Will have subsequent THA or TKA within 12 weeks of the index study procedure.
• Pregnant.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (2)

University of Iowa Hospitals & Clinics

Iowa City, Iowa, 52242, United States

Location

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

Related Publications (3)

• Inabathula A, Dilley JE, Ziemba-Davis M, Warth LC, Azzam KA, Ireland PH, Meneghini RM. Extended Oral Antibiotic Prophylaxis in High-Risk Patients Substantially Reduces Primary Total Hip and Knee Arthroplasty 90-Day Infection Rate. J Bone Joint Surg Am. 2018 Dec 19;100(24):2103-2109. doi: 10.2106/JBJS.17.01485.

  PMID: 30562290 BACKGROUND

• Li B, Webster TJ. Bacteria antibiotic resistance: New challenges and opportunities for implant-associated orthopedic infections. J Orthop Res. 2018 Jan;36(1):22-32. doi: 10.1002/jor.23656. Epub 2017 Aug 11.

  PMID: 28722231 BACKGROUND

• Kurtz SM, Lau E, Watson H, Schmier JK, Parvizi J. Economic burden of periprosthetic joint infection in the United States. J Arthroplasty. 2012 Sep;27(8 Suppl):61-5.e1. doi: 10.1016/j.arth.2012.02.022. Epub 2012 May 2.

  PMID: 22554729 BACKGROUND

MeSH Terms

Conditions

Overweight; Obesity; Renal Insufficiency, Chronic; Diabetes Mellitus; Autoimmune Diseases; Tobacco Use

Interventions

Cephalexin; Doxycycline; Cefadroxil

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Immune System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Nicholas Bedard, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 3, 2020
• First Posted: March 5, 2020
• Study Start: June 11, 2020
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)