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Prospective Evaluation of Oral Antibiotics for Treatment of Shoulder PJI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04636125
Recruitment Status : Enrolling by invitation
First Posted : November 19, 2020
Last Update Posted : November 19, 2020
Sponsor:
Information provided by (Responsible Party):
Rothman Institute Orthopaedics

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).


Condition or disease Intervention/treatment Phase
Periprosthetic Infection Oral Antibiotics Revision Total Shoulder Arthroplasty Drug: Doxycycline 100 MG Oral Tablet Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Evaluation of Oral Antibiotics for Treatment of Shoulder PJI
Actual Study Start Date : September 24, 2019
Estimated Primary Completion Date : September 24, 2021
Estimated Study Completion Date : September 24, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Rate of Postoperative Infections [ Time Frame: 1 year ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04636125


Locations
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United States, Pennsylvania
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Rothman Institute Orthopaedics
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Responsible Party: Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier: NCT04636125    
Other Study ID Numbers: SNAM18D.443
First Posted: November 19, 2020    Key Record Dates
Last Update Posted: November 19, 2020
Last Verified: November 2020

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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
Additional relevant MeSH terms:
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Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents