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Could a week of antibiotics stop joint infections after replacement surgery?

NCT ID NCT04297592

Disease control Sponsor: Mayo Clinic Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time

Summary

This study tests whether taking a 7-day course of oral antibiotics after hip or knee replacement surgery can prevent joint infections in patients at higher risk due to conditions like obesity, diabetes, or autoimmune disease. About 4,600 participants will receive one of three antibiotics (cephalexin, doxycycline, or cefadroxil) or a placebo. The goal is to see if this simple preventive step reduces infections and wound complications.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Cephalexin, Doxycycline, or Cefadroxil
What this could lead to
If effective, a short course of oral antibiotics could reduce the risk of serious joint infections after hip or knee replacement in people with conditions like diabetes or obesity.
What could go wrong
This is a Phase 4 trial, so the drugs are already approved, but the specific benefit in this high-risk group is unproven. Antibiotics can cause side effects like allergic reactions or diarrhea, and overuse may contribute to antibiotic resistance.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 4,618 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2020

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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). Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

autoimmune disease chronic kidney disease chronic renal failure syndrome diabetes mellitus inflammatory disease methicillin-resistant staphylococcus aureus infectious disease methicillin-susceptible staphylococcus aureus infectious disease nicotine dependence Obesity obesity disorder osteoarthritis Overweight Tobacco Use periprosthetic joint infection prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Autoimmune diseases Chronic kidney diseases Diabetes Infections joint prosthetic Inflammatory disease MRSA Mssa colonization Overweight or obesity Tobacco use

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Mayo Clinic

    Rochester, Minnesota, 55902, United States

  • University of Iowa Hospitals & Clinics

    Iowa City, Iowa, 52242, United States

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