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Prospective Evaluation of Oral Antibiotics for Treatment of Shoulder PJI

NCT04636125 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-11-19

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Rothman Institute Orthopaedics

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-24
Primary Completion
2021-09-24
Completion
2021-09-24
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT04636125 on ClinicalTrials.gov