MedTrace Logo

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

NCT05495815 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2026-02-10

No results posted yet for this study

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). 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.

Conditions

  • Periprosthetic Joint Infection
  • Antibiotic Suppression

Interventions

DRUG

6 months of SAT

6 months of oral suppressive antibiotic therapy

DRUG

12 months of SAT

12 months of oral suppressive antibiotic therapy

DRUG

Indefinite SAT

Indefinite oral suppressive antibiotic therapy

Sponsors & Collaborators

  • OrthoCarolina Research Institute, Inc.

    collaborator OTHER

  • University of Arkansas

    collaborator OTHER

  • OrthoMichigan

    collaborator UNKNOWN

  • NYU School of Medicine

    collaborator UNKNOWN

  • Sinai Hospital

    collaborator UNKNOWN

  • MedStar Health

    collaborator OTHER

  • University of Maryland, Baltimore

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-31
Primary Completion
2026-02-28
Completion
2026-06-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05495815 on ClinicalTrials.gov