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No participants enrolled.
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| Name | Class |
|---|---|
| OrthoCarolina Research Institute, Inc. | OTHER |
| University of Arkansas | OTHER |
| OrthoMichigan | UNKNOWN |
| NYU School of Medicine |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 6 months of SAT | Active Comparator | TJA DAIR, followed by 6 weeks of IV antibiotics then 6 months of oral suppressive antibiotic therapy |
|
| 12 months of SAT | Active Comparator | TJA DAIR, followed by 6 weeks of IV antibiotics then 12 months of oral suppressive antibiotic therapy |
|
| Indefinite SAT | Active Comparator | TJA DAIR, followed by 6 weeks of IV antibiotics then indefinite oral suppressive antibiotic therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 6 months of SAT | Drug | 6 months of oral suppressive antibiotic therapy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Reoperation for infection recurrence | 2 years after patient enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Antibiotic resistance, evidenced by change in antimicrobial sensitivity profile, developed by infecting organism after suppressive antibiotic therapy causing infection recurrence | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland | Baltimore | Maryland | 21201 | United States |
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| ID | Term |
|---|---|
| C287333 | diamine N-acetyltransferase |
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| UNKNOWN |
| Sinai Hospital | UNKNOWN |
| MedStar Health | OTHER |
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| 12 months of SAT |
| Drug |
12 months of oral suppressive antibiotic therapy |
|
| Indefinite SAT | Drug | Indefinite oral suppressive antibiotic therapy |
|
Antibiotic intolerance is any Grade I sign from CTCAE v5.0, while adverse drug reaction is any Grade 2 sign or higher. |
| During antibiotic administration (up to 2 years after patient enrollment) |