Prospective Evaluation of Oral Antibiotics for Treatment of Shoulder PJI

Oral Antibiotics Clinical Trial

Official title:

Prospective Evaluation of Oral Antibiotics for Treatment of Shoulder PJI

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04636125
• Other study ID #: SNAM18D.443
• Status: Enrolling by invitation
• Phase: Phase 3
• Start date: September 24, 2019
• Est. completion date: September 24, 2021

Study information

• Verified date: November 2020
• Source: Rothman Institute Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: September 24, 2021
• Est. primary completion date: September 24, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Oral Antibiotics
• Periprosthetic Infection
• Revision Total Shoulder Arthroplasty

Intervention

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.

Locations

Country	Name	City	State
United States	Rothman Orthopaedic Institute	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Rothman Institute Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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