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Indefinite SAT for Antibiotic Resistance (ProperSAT Trial)
N/A
Recruiting
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during antibiotic administration (up to 2 years after patient enrollment)
Awards & highlights
ProperSAT Trial Summary
"This trial aims to study the use of oral antibiotics after joint replacement surgery to treat joint infections. Previous studies have shown that this approach can improve survival without needing further surgery. However, there is not enough
Who is the study for?
This trial is for adults over 18 who had a specific surgery (DAIR with modular component exchange) for an acute joint infection after a total joint arthroplasty, with symptoms lasting less than 4 weeks. They must have been on oral antibiotics post-surgery for at least 3 months.Check my eligibility
What is being tested?
The study tests how long to give suppressive antibiotic therapy (SAT) after the DAIR procedure: indefinitely, for 6 months, or for 12 months. It aims to see which duration minimizes complications like drug reactions and reoperations due to infections while also considering antibiotic resistance.See study design
What are the potential side effects?
Potential side effects from long-term use of antibiotics may include allergic reactions, gastrointestinal issues like nausea or diarrhea, liver and kidney function changes, and possibly developing resistance to the antibiotics used.
ProperSAT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years after patient enrollment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years after patient enrollment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Reoperation for infection recurrence
Secondary outcome measures
Adverse drug reaction or intolerance, defined as any symptom or laboratory value derangement requiring a change in, or discontinuation of, antimicrobial therapy
Antibiotic resistance, evidenced by change in antimicrobial sensitivity profile, developed by infecting organism after suppressive antibiotic therapy causing infection recurrence
ProperSAT Trial Design
3Treatment groups
Active Control
Group I: Indefinite SATActive Control1 Intervention
TJA DAIR, followed by 6 weeks of IV antibiotics then indefinite oral suppressive antibiotic therapy
Group II: 6 months of SATActive Control1 Intervention
TJA DAIR, followed by 6 weeks of IV antibiotics then 6 months of oral suppressive antibiotic therapy
Group III: 12 months of SATActive Control1 Intervention
TJA DAIR, followed by 6 weeks of IV antibiotics then 12 months of oral suppressive antibiotic therapy
Find a Location
Who is running the clinical trial?
New England Baptist HospitalUNKNOWN
OrthoMichiganUNKNOWN
NYU School of MedicineUNKNOWN
2 Previous Clinical Trials
775 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are actively involved in this research endeavor?
"Indeed, data available on clinicaltrials.gov indicates that this particular medical investigation is actively seeking suitable candidates. The study was initially posted on April 1st, 2024 and last revised on April 7th, 2024. A total of 438 participants are sought from a single designated site for enrollment."
Answered by AI
Is the enrollment for this investigation presently open?
"As per clinicaltrials.gov, this investigation is actively seeking participants. The trial was initially shared on April 1st, 2024 and last revised on April 7th, 2024."
Answered by AI
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