OsteoarthritisNCT03115177
Can Addition of Doxycycline Perioperatively Reduce Propionibacterium Acnes in Shoulder Arthroplasty?
A study testing Doxycycline and Cefazolin in people with Osteoarthritis, run by Rush University Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to investigate antibiotic treatment to target bacteria about the shoulder. This bacteria, Propionibacterium acnes, is detected in many revision shoulder surgeries and is thought to contribute to periprosthetic joint infections, pain, and failure of total shoulder arthroplasty as well as… Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Doxycycline and Cefazolin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Feb 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing primary total shoulder arthroplasty at Rush University Medical Center
Who cannot join
- Patients with prior shoulder surgery of any kind
- Patients with a known infection or history of infection with clinical signs such as elevated erythrocyte sedimentation rate, C-reactive protein, positive culture aspiration
- Patients with a known allergy to doxycycline
- Patients with a known allergy to cefazolin or penicillin
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
The purpose of this study is to investigate antibiotic treatment to target bacteria about the shoulder. This bacteria, Propionibacterium acnes, is detected in many revision shoulder surgeries and is thought to contribute to periprosthetic joint infections, pain, and failure of total shoulder arthroplasty as well as other shoulder surgeries. This study is investigating adding an FDA approved antibiotic that is commonly used for treatment of this bacteria and many common infections. The investigators will take intraoperative cultures to look for the presence or absence of specific bacteria. The investigators are conducting this trial to see if adding another antibiotic to specifically target this common bacteria found around the shoulder will be effective.
Read the detailed description
Patients undergoing total and reverse shoulder arthroplasty for primary glenohumeral arthritis will be invited to participate in this study if patients meet inclusion and exclusion criteria. Patients will be randomized to receive either standard perioperative antibiotics with cefazolin or to the treatment group to receive doxycycline in addition to cefazolin. Patients will then undergo routine surgical treatment. 3 cultures from the superficial tissue, dermis, and glenohumeral joint will be taken and cultured for 14 days to detect any bacterial growth.
- Conditions
- Osteoarthritis
- Being tested
- Doxycycline, Cefazolin
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxycyclineDrug
The treatment group will receive 100mg of doxycycline IV in addition to cefazolin within 1 hour of incision for total shoulder arthroplasty.
CefazolinDrug
| Study group | Role | What they receive |
|---|---|---|
| Cefazolin | Active comparator | All patients will receive standard perioperative antibiotics with 2g of cefazolin within 1 hour of incision. The control group will not receive any further antibiotic treatment. Receives: Drug: Cefazolin |
| Doxycycline+Cefazolin Group | Active comparator | All patients will receive standard perioperative antibiotics with 2g of cefazolin within 1 hour of incision. The treatment group will receive 100mg of doxycycline IV in addition to cefazolin within 1 hour of incision. Receives: Drug: Doxycycline; Drug: Cefazolin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial Culture
Intraoperative cultures will be taken from all study participants and tested for detection of bacteria. These cultures were held for 14 days and tested for aerobic and anaerobic bacteria. Reported data are presented for the number of participants with a positive bacteria culture from the intraoperative samples.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study startNov 2015
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Allison Rao, Rush University Medical Center
- Investigators
- Allison Rao, MD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03115177
- Sponsor's protocol ID
- 15052002
- Status last verified
- May 2018
- First submitted
- 25 Apr 2016
- Last updated
- 15 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Addition of Doxycycline Perioperatively Reduce Propionibacterium Acnes in Shoulder Arthroplasty?
- ClinicalTrials.gov ID
- NCT03115177
- Acronym / sponsor ID
- 15052002
- Conditions
- Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 14 Apr 2017 (actual)
- Results
- Posted 15 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate antibiotic treatment to target bacteria about the shoulder. This bacteria, Propionibacterium acnes, is detected in many revision shoulder surgeries and is thought to contribute to periprosthetic joint infections, pain, and failure of total shoulder arthroplasty as well as other shoulder surgeries. This study is investigating adding an FDA approved antibiotic that is commonly used for treatment of this bacteria and many common infections. The investigators will take intraoperative cultures to look for the presence or absence of specific bacteria. The investigators are conducting this trial to see if adding another antibiotic to specifically target this common bacteria found around the shoulder will be effective.
Detailed description
Patients undergoing total and reverse shoulder arthroplasty for primary glenohumeral arthritis will be invited to participate in this study if patients meet inclusion and exclusion criteria. Patients will be randomized to receive either standard perioperative antibiotics with cefazolin or to the treatment group to receive doxycycline in addition to cefazolin. Patients will then undergo routine surgical treatment. 3 cultures from the superficial tissue, dermis, and glenohumeral joint will be taken and cultured for 14 days to detect any bacterial growth.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cefazolin | Active comparator | Drug: CefazolinAll patients will receive standard perioperative antibiotics with 2g of cefazolin within 1 hour of incision. The control group will not receive any further antibiotic treatment. |
| Doxycycline+Cefazolin Group | Active comparator | Drug: Doxycycline, Drug: CefazolinAll patients will receive standard perioperative antibiotics with 2g of cefazolin within 1 hour of incision. The treatment group will receive 100mg of doxycycline IV in addition to cefazolin within 1 hour of incision. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing primary total shoulder arthroplasty at Rush University Medical Center
Key exclusion criteria (4 listed)
- Patients with prior shoulder surgery of any kind
- Patients with a known infection or history of infection with clinical signs such as elevated erythrocyte sedimentation rate, C-reactive protein, positive culture aspiration
- Patients with a known allergy to doxycycline
- Patients with a known allergy to cefazolin or penicillin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DoxycyclineThe treatment group will receive 100mg of doxycycline IV in addition to cefazolin within 1 hour of incision for total shoulder arthroplasty. | Drug | Doxycycline+Cefazolin Group |
| Cefazolin | Drug | Cefazolin, Doxycycline+Cefazolin Group |
Primary outcome
Bacterial Culture
Time frame: 2 weeks
Intraoperative cultures will be taken from all study participants and tested for detection of bacteria. These cultures were held for 14 days and tested for aerobic and anaerobic bacteria. Reported data are presented for the number of participants with a positive bacteria culture from the intraoperative samples.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allison Rao, MD principal investigator
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Doxycycline and Cefazolin in people with Osteoarthritis, run by Rush University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bacterial Culture (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2018.