Prospective Evaluation of Oral Antibiotics for Treatment of Shoulder PJI
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|ClinicalTrials.gov Identifier: NCT04636125|
Recruitment Status : Enrolling by invitation
First Posted : November 19, 2020
Last Update Posted : November 19, 2020
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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
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
|United States, Pennsylvania|
|Rothman Orthopaedic Institute|
|Philadelphia, Pennsylvania, United States, 19107|