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Infections Joint ProstheticPhase 4NCT04297592

Antibiotic Prophylaxis in High-Risk Arthroplasty Patients

A Phase 4 study testing Cephalexin, Doxycycline and Cefadroxil in people with Infections Joint Prosthetic and Overweight or Obesity, run by Mayo Clinic at 2 sites in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 99 years
What is being tested?
Cephalexin, Doxycycline and Cefadroxil
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,618 participants
Where
2 sitesUnited States
Study dates
11 Jun 2020to Jan 2028
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.
Show all 10Show fewer
  • Unicompartmental knee arthroplasty.
  • Simultaneous bilateral THA or TKA.
  • Will have subsequent THA or TKA within 12 weeks of the index study procedure.
  • Pregnant.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

United States2 sites

  • University of Iowa Hospitals & Clinics

    Iowa City, Iowa, 52242

  • Mayo Clinic

    Rochester, Minnesota, 55902

Other trials in United States

About this study

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.

Read the detailed description

The purpose of this research study is to investigate whether a 7-day course of an oral, prophylactic antibiotic following elective, primary total hip and knee arthroplasty effectively decreases the risk of periprosthetic joint infection or wound complications following surgery in a patient population that is high-risk for these complications. Patient with one or more of the following risk factors are considered high-risk for periprosthetic joint infection and/or wound complications: body mass index over 35kg/m^2, diagnosis of diabetes, chronic kidney disease, active tobacco user, nasal colonization of methicillin-resistant Staphylococcus aureus and/or methicillin-sensitive Staphylococcus aureus, or autoimmune/inflammatory disease.

Study participants will be randomized to either a 7-day course of an oral, prophylactic antibiotic following surgery or no additional antibiotic. All other standard perioperative total joint arthroplasty care will remain the same for both groups, including 24-hours of perioperative antibiotics. Outcomes assessed will include surgical wound complications occurring within 90-day of surgery and periprosthetic joint infection occurring within 90-day and 1-year of surgery.

Being tested
Cephalexin, Doxycycline, Cefadroxil
Keywords
total hip arthroplasty, total knee arthroplasty, hip replacement, knee replacement, periprosthetic joint infection, prophylaxis, antibiotics
Medical subject headings
Overweight, Obesity, Renal Insufficiency, Chronic, Diabetes Mellitus, Autoimmune Diseases, Tobacco Use

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CephalexinDrug

    Also called Keflex

    500 mg oral tablet, 4 times daily for 7 days

  • DoxycyclineDrug

    100 mg oral tablet, 2 times daily for 7 days

  • CefadroxilDrug

    Also called Duricef

    500 mg oral tablet, 2 times daily for 7 days

Study groups in NCT04297592
Study groupRoleWhat they receive
Additional Antibiotic GroupActive comparatorPatients 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.
Receives: Drug: Cephalexin; Drug: Doxycycline; Drug: Cefadroxil
Control Group - No Additional AntibioticNo interventionPatients will receive standard perioperative antibiotics following primary hip or knee arthroplasty and no additional antibiotics.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Periprosthetic joint infections

    Defined by Musculoskeletal Infection Society (MSIS) criteria

    Measured: Within 90-days primary hip or knee arthroplasty

  2. Periprosthetic joint infections

    Defined by Musculoskeletal Infection Society (MSIS) criteria

    Measured: Within 1-year of primary hip or knee arthroplasty

Secondary outcomes (1)

  1. Wound complication

    Defined by at least one of the following: surgical wound dehiscence, skin necrosis at the surgical site, persistent surgical wound drainage (fluid extrusion from the operative site occurring beyond 72 hours from index surgery), superficial surgical site infection treated with new prescription of antibiotics or a change in study antibiotics but not meeting criteria for periprosthetic joint infection.

    Measured: Within 90 days of primary hip or knee arthroplasty

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2020
  2. Study start11 Jun 2020
  3. Primary completionJan 2027 (estimated)
  4. Study completionJan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
4,618 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04297592
Sponsor's protocol ID
22-001273
Status last verified
Jul 2026
First submitted
3 Mar 2020
Last updated
6 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30562290

  • 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.

    PubMed 28722231

  • 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.

    PubMed 22554729

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Cephalexin, Doxycycline and Cefadroxil in people with Infections Joint Prosthetic and Overweight or Obesity, run by Mayo Clinic at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Periprosthetic joint infections (time frame: Within 90-days primary hip or knee arthroplasty). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04297592, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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