drugset / Trial / NCT04636125

Prospective Evaluation of Oral Antibiotics for Treatment of Shoulder PJI

NCT04636125

Phase 3 Unknown 100 enrolled Rothman Institute Orthopaedics
NaSingle-groupOpen-labelTreatment

Summary

Cutibacterium acnes (C. acnes) is an anaerobic aerotolerant bacteria commonly isolated during revision shoulder surgery. It is increasingly recognized as a pathogen, mainly in implant-related infections. As an anaerobe, it usually needs a prolonged culture incubation time of up to 14 days for growth and the association between implant surgery and C. acnes infection is not always obvious. Unfortunately, prolonged incubation also increases the risk of false positive cultures in isolating organisms that may exist as a result of contamination. Given high rates of positive C. acnes cultures in cases of both primary and revision shoulder surgery, the ramifications of positive C. acnes cultures for clinical decision making remains uncertain. The purpose of this study is to prospectively study the efficacy and side-effect profile of surgical treatment plus an oral antibiotic regiment for shoulder PJI with indolent organisms (C. acnes and CNS).

Timeline

Start
2019-09-24
Primary completion
2021-09-24
Completion
2021-09-24

Drugs

EvaluationDrugModalityDoseRoute
Subject Doxycycline Small molecule 100 mg Oral