NCT04297592Enrolling by invitationPhase 4
Antibiotic Prophylaxis in High-Risk Arthroplasty Patients
Source: ClinicalTrials.gov · Last updated 6 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 4618 (estimated)
- First submitted
- 3 Mar 2020
- Start date
- 11 Jun 2020
- Primary completion date
- Jan 2027
- Lead sponsor
- Mayo Clinic
- Diseases
- Chronic kidney disease, Obesity
- NCT number
- NCT04297592
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 4618
- From 11 Jun 2020 to the primary completion date, Jan 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Non-elective surgery.
Other illness
- Allergy to antibiotic alternatives in the protocol.
- History of clostridium difficile colitis.
Other
- Inability to consume oral antibiotics.
- Revision hip or knee arthroplasty procedure.
- Hemiarthroplasty.
- Unicompartmental knee arthroplasty.
- Simultaneous bilateral THA or TKA.
- Will have subsequent THA or TKA within 12 weeks of the index study procedure.
- Pregnant.
Who the study is looking for
- 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).
Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Iowa Hospitals & Clinics Coordinator of this site? Confirm its status | Iowa City | United States | Unknown status |
| Mayo Clinic Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.