Periprosthetic Joint InfectionProperSATNCT05495815
Proper Duration of Suppressive Antibiotic Therapy After Debridement, Antibiotics, and Implant Retention
A study testing 6 months of SAT, 12 months of SAT and Indefinite SAT in people with Periprosthetic Joint Infection and Antibiotic Suppression, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
Multiple studies have demonstrated oral suppressive antibiotic therapy (SAT), after intravenous antibiotics, maximizes reoperation-free survival of total joint arthroplasty (TJA) debridement, antibiotics, and implant retention (DAIR) for acute periprosthetic joint infection (PJI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periprosthetic Joint Infection, Antibiotic Suppression
- What is being tested?
- 6 months of SAT, 12 months of SAT and Indefinite SAT
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2024to Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- over 18 years-old
- underwent DAIR with modular component exchange for acute TJA PJI, as defined by Musculoskeletal Infection Society Criteria, with symptom duration less than 4 weeks
- on postoperative oral SAT for at least 3 months
Who cannot join
- underwent aseptic revision surgery
- had one-stage, 1.5-stage, or two-stage revision surgery
- did not have postoperative SAT
- did not have follow-up that allowed for evaluation of SAT sequelae
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Clinical Trial Determining Proper Duration of Suppressive Antibiotic Therapy After Total Joint Arthroplasty Debridement, Antibiotics, and Implant Retention
Multiple studies have demonstrated oral suppressive antibiotic therapy (SAT), after intravenous antibiotics, maximizes reoperation-free survival of total joint arthroplasty (TJA) debridement, antibiotics, and implant retention (DAIR) for acute periprosthetic joint infection (PJI). However, little is known regarding sequelae of SAT after DAIR for PJI. Prior studies have small or heterogeneous patient cohorts, variable antibiotic regimens, arrive at disparate conclusions, and do not establish antibiotic resistance risk.
The investigators propose a prospective randomized controlled multicenter study to expand on findings in a retrospective, multi-center pilot study. Study aims are to evaluate SAT after DAIR of acutely infected primary TJA regarding: 1) adverse drug reactions/intolerance; 2) reoperation for infection; and 3) antibiotic resistance.
- Being tested
- 6 months of SAT, 12 months of SAT, Indefinite SAT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6 months of SATDrug
6 months of oral suppressive antibiotic therapy
12 months of SATDrug
12 months of oral suppressive antibiotic therapy
Indefinite SATDrug
Indefinite oral suppressive antibiotic therapy
| Study group | Role | What they receive |
|---|---|---|
| 6 months of SAT | Active comparator | TJA DAIR, followed by 6 weeks of IV antibiotics then 6 months of oral suppressive antibiotic therapy Receives: Drug: 6 months of SAT |
| 12 months of SAT | Active comparator | TJA DAIR, followed by 6 weeks of IV antibiotics then 12 months of oral suppressive antibiotic therapy Receives: Drug: 12 months of SAT |
| Indefinite SAT | Active comparator | TJA DAIR, followed by 6 weeks of IV antibiotics then indefinite oral suppressive antibiotic therapy Receives: Drug: Indefinite SAT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reoperation for infection recurrence
Measured: 2 years after patient enrollment
Secondary outcomes (2)
Antibiotic resistance, evidenced by change in antimicrobial sensitivity profile, developed by infecting organism after suppressive antibiotic therapy causing infection recurrence
Measured: At time of reoperation (within 2 years of patient enrollment)
Adverse drug reaction or intolerance, defined as any symptom or laboratory value derangement requiring a change in, or discontinuation of, antimicrobial therapy
Antibiotic intolerance is any Grade I sign from CTCAE v5.0, while adverse drug reaction is any Grade 2 sign or higher.
Measured: During antibiotic administration (up to 2 years after patient enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study startDec 2024 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionJun 2026 (estimated)
Why it stopped: No participants enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periprosthetic Joint InfectionStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- OrthoCarolina Research Institute, Inc., University of Arkansas, OrthoMichigan, NYU School of Medicine, Sinai Hospital, MedStar Health
- Responsible party
- Principal investigator, Sumon Nandi, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05495815
- Sponsor's protocol ID
- Maryland
- Acronym
- ProperSAT
- Status last verified
- Feb 2026
- First submitted
- 5 Aug 2022
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial Determining Proper Duration of Suppressive Antibiotic Therapy After Total Joint Arthroplasty Debridement, Antibiotics, and Implant Retention
- ClinicalTrials.gov ID
- NCT05495815
- Acronym / sponsor ID
- ProperSAT / Maryland
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- OrthoCarolina Research Institute, Inc., University of Arkansas, OrthoMichigan, NYU School of Medicine, Sinai Hospital, MedStar Health
- Study start
- Dec 2024 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 10 Aug 2022 (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.
Multiple studies have demonstrated oral suppressive antibiotic therapy (SAT), after intravenous antibiotics, maximizes reoperation-free survival of total joint arthroplasty (TJA) debridement, antibiotics, and implant retention (DAIR) for acute periprosthetic joint infection (PJI). However, little is known regarding sequelae of SAT after DAIR for PJI. Prior studies have small or heterogeneous patient cohorts, variable antibiotic regimens, arrive at disparate conclusions, and do not establish antibiotic resistance risk.
The investigators propose a prospective randomized controlled multicenter study to expand on findings in a retrospective, multi-center pilot study. Study aims are to evaluate SAT after DAIR of acutely infected primary TJA regarding: 1) adverse drug reactions/intolerance; 2) reoperation for infection; and 3) antibiotic resistance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 6 months of SAT | Active comparator | Drug: 6 months of SATTJA DAIR, followed by 6 weeks of IV antibiotics then 6 months of oral suppressive antibiotic therapy |
| 12 months of SAT | Active comparator | Drug: 12 months of SATTJA DAIR, followed by 6 weeks of IV antibiotics then 12 months of oral suppressive antibiotic therapy |
| Indefinite SAT | Active comparator | Drug: Indefinite SATTJA DAIR, followed by 6 weeks of IV antibiotics then indefinite oral suppressive antibiotic therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- over 18 years-old
- underwent DAIR with modular component exchange for acute TJA PJI, as defined by Musculoskeletal Infection Society Criteria, with symptom duration less than 4 weeks
- on postoperative oral SAT for at least 3 months
Key exclusion criteria (4 listed)
- underwent aseptic revision surgery
- had one-stage, 1.5-stage, or two-stage revision surgery
- did not have postoperative SAT
- did not have follow-up that allowed for evaluation of SAT sequelae
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 |
|---|---|---|
| 6 months of SAT6 months of oral suppressive antibiotic therapy | Drug | 6 months of SAT |
| 12 months of SAT12 months of oral suppressive antibiotic therapy | Drug | 12 months of SAT |
| Indefinite SATIndefinite oral suppressive antibiotic therapy | Drug | Indefinite SAT |
Primary outcome
Reoperation for infection recurrence
Time frame: 2 years after patient enrollment
2 secondary outcomes
Antibiotic resistance, evidenced by change in antimicrobial sensitivity profile, developed by infecting organism after suppressive antibiotic therapy causing infection recurrence
Time frame: At time of reoperation (within 2 years of patient enrollment)
Adverse drug reaction or intolerance, defined as any symptom or laboratory value derangement requiring a change in, or discontinuation of, antimicrobial therapy
Time frame: During antibiotic administration (up to 2 years after patient enrollment)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 6 months of SAT, 12 months of SAT and Indefinite SAT in people with Periprosthetic Joint Infection and Antibiotic Suppression, run by University of Maryland, Baltimore at 1 site 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 3 inclusion and 4 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: withdrawn, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Reoperation for infection recurrence (time frame: 2 years after patient enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Feb 2026.