NCT04636125

Prospective Evaluation of Oral Antibiotics for Treatment of Shoulder PJI

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Rothman Institute Orthopaedics · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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).

Conditions

• Periprosthetic Infection
• Oral Antibiotics
• Revision Total Shoulder Arthroplasty

Interventions

Type	Name	Description
DRUG	Doxycycline 100 MG Oral Tablet	Patients that are undergoing a single stage revision total shoulder arthroplasty will be enrolled in this study. As is standard of care, routine cultures will be taken from predetermined areas in the shoulder. All patients will be treated with 13 days of oral Doxycycline pending culture results.

Timeline

• Start date: 2019-09-24
• Primary completion: 2021-09-24
• Completion: 2021-09-24
• First posted: 2020-11-19
• Last updated: 2020-11-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study