Proper Duration of Suppressive Antibiotic Therapy After Debridement, Antibiotics, and Implant Retention

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

438 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-31

Study Completion Date

2026-06-30

Brief Summary

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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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Detailed Description

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Conditions

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Periprosthetic Joint Infection Antibiotic Suppression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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6 months of SAT

TJA DAIR, followed by 6 weeks of IV antibiotics then 6 months of oral suppressive antibiotic therapy

Group Type ACTIVE_COMPARATOR

6 months of SAT

Intervention Type DRUG

6 months of oral suppressive antibiotic therapy

12 months of SAT

TJA DAIR, followed by 6 weeks of IV antibiotics then 12 months of oral suppressive antibiotic therapy

Group Type ACTIVE_COMPARATOR

12 months of SAT

Intervention Type DRUG

12 months of oral suppressive antibiotic therapy

Indefinite SAT

TJA DAIR, followed by 6 weeks of IV antibiotics then indefinite oral suppressive antibiotic therapy

Group Type ACTIVE_COMPARATOR

Indefinite SAT

Intervention Type DRUG

Indefinite oral suppressive antibiotic therapy

Interventions

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6 months of SAT

6 months of oral suppressive antibiotic therapy

Intervention Type DRUG

12 months of SAT

12 months of oral suppressive antibiotic therapy

Intervention Type DRUG

Indefinite SAT

Indefinite oral suppressive antibiotic therapy

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No