Prospective Evaluation of Oral Antibiotics for Treatment of Shoulder PJI

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).

Study Overview

• Status: Unknown
• Conditions: Oral Antibiotics; Periprosthetic Infection; Revision Total Shoulder Arthroplasty
• Intervention / Treatment: Drug: Doxycycline 100 MG Oral Tablet

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Rothman Orthopaedic Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. all patients undergoing single-stage revision arthroplasty with all implants exchanged,
2. all patients undergoing single-stage revision arthroplasty with some implants retained,
3. all patients undergoing explantation of a shoulder arthroplasty and placement of an antibiotic spacer

Exclusion Criteria:

1. patients with polymicrobial infection,
2. patients with infection by organisms other than P. acnes or Coagulase Negative Staphylococcus,
3. patients with clinical suspicion of infection but negative cultures,
4. patients with no preoperative or intraoperative signs of infection and only 1 positive culture.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Revision Total Shoulder Arthroplasty; Routine cultures are taken at the time of surgery. All patients are seen by an Infectious Disease Specialist and placed on 2 weeks oral doxycycline 100 mg (or alternative based on allergy or sensitivity) pending culture results.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Postoperative Infections	The investigator will measure the incidence of postoperative infections in participants treated with oral antibiotics after revision shoulder surgery versus those treated with intravenous antibiotics after surgery	1 year

Collaborators and Investigators

• Sponsor: Rothman Institute Orthopaedics

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 24, 2019
• Primary Completion (ANTICIPATED): September 24, 2021
• Study Completion (ANTICIPATED): September 24, 2021

Study Registration Dates

• First Submitted: October 21, 2020
• First Submitted That Met QC Criteria: November 18, 2020
• First Posted (ACTUAL): November 19, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 19, 2020
• Last Update Submitted That Met QC Criteria: November 18, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Doxycycline
• Other Study ID Numbers: SNAM18D.443

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes