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.
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
- Conditions the study is for
- Infections Joint Prosthetic, Overweight or Obesity, MSSA Colonization
- 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
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.
- Conditions
- Infections Joint Prosthetic, Overweight or Obesity, MSSA Colonization, MRSA, Chronic Kidney Diseases, Diabetes
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periprosthetic joint infections
Defined by Musculoskeletal Infection Society (MSIS) criteria
Measured: Within 90-days primary hip or knee arthroplasty
Periprosthetic joint infections
Defined by Musculoskeletal Infection Society (MSIS) criteria
Measured: Within 1-year of primary hip or knee arthroplasty
Secondary outcomes (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.
- First posted5 Mar 2020
- Study start11 Jun 2020
- Primary completionJan 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Infections Joint ProstheticStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicholas A. Bedard, Mayo Clinic
- Investigators
- Nicholas Bedard, MD, Principal investigator, Mayo Clinic
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 30562290Li 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 28722231Kurtz 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
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotic Prophylaxis in High-Risk Arthroplasty Patients
- ClinicalTrials.gov ID
- NCT04297592
- Acronym / sponsor ID
- 22-001273
- Conditions
- Infections Joint Prosthetic, Overweight or Obesity, MSSA Colonization, MRSA, Chronic Kidney Diseases, Diabetes
- Keywords
- total hip arthroplasty, total knee arthroplasty, hip replacement, knee replacement, periprosthetic joint infection, prophylaxis, antibiotics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 4,618 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 11 Jun 2020 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 5 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Additional Antibiotic Group | Active comparator | Drug: Cephalexin, Drug: Doxycycline, Drug: CefadroxilPatients 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. |
| Control Group - No Additional Antibiotic | No intervention | –Patients will receive standard perioperative antibiotics following primary hip or knee arthroplasty and no additional antibiotics. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CephalexinAlso: Keflex500 mg oral tablet, 4 times daily for 7 days | Drug | Additional Antibiotic Group |
| Doxycycline100 mg oral tablet, 2 times daily for 7 days | Drug | Additional Antibiotic Group |
| CefadroxilAlso: Duricef500 mg oral tablet, 2 times daily for 7 days | Drug | Additional Antibiotic Group |
Primary outcome
Periprosthetic joint infections
Time frame: Within 90-days primary hip or knee arthroplasty
Defined by Musculoskeletal Infection Society (MSIS) criteria
Periprosthetic joint infections
Time frame: Within 1-year of primary hip or knee arthroplasty
Defined by Musculoskeletal Infection Society (MSIS) criteria
1 secondary outcome
Wound complication
Time frame: Within 90 days of primary hip or knee arthroplasty
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Background: PubMed 30562290Inabathula 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.
- Background: PubMed 28722231Li 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.
- Background: PubMed 22554729Kurtz 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicholas Bedard, MD principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
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.