Prospective Evaluation of Oral Antibiotics for Treatment of Shoulder PJI

NCT04636125 | Unknown Phase 3 FDA Drug

• 1 other identifier: SNAM18D.443
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Revision Total Shoulder Arthroplasty

OTHER

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

Interventions

Doxycycline 100 MG Oral Tablet DRUG

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.

Revision Total Shoulder Arthroplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Rothman Institute Orthopaedics: lead

Study Sites (1)

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Interventions

Doxycycline; Tablets

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2020
• First Posted: November 19, 2020
• Study Start: September 24, 2019
• Primary Completion: September 24, 2021
• Study Completion: September 24, 2021
• Last Updated: November 19, 2020

Record last verified: 2020-11

Locations

US (1)