Prosthesis-Related InfectionsNCT01760863
Oral Antibiotics After 2-Stage Revision for Infected Total Hip Arthroplasty and Total Knee Arthroplasty
A study testing Oral Antibiotics in people with Prosthesis-Related Infections, run by Rush University Medical Center at 4 sites in United States.
Trial summary
The primary purpose of this study is to compare the re-infection rates in patients undergoing 2-stage revision arthroplasty who receive additional oral antibiotic therapy to those patients who received in-hospital perioperative antibiotic only. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Prosthesis-Related Infections
- What is being tested?
- Oral Antibiotics
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 185 participants
- Where
- 4 sitesUnited States
- Study dates
- Jul 2011to 23 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients undergoing 2-stage revision arthroplasty of the knee or hip with the causative organism(s) identified using tissue culture and/or joint fluid analysis that is amenable to oral antibiotic therapy. Patients must be able to tolerate oral antibiotics and agree to participate in the study.
Who cannot join
- Patients with a fungal prosthetic joint infection, unable to tolerate or refuse to undergo oral antibiotic therapy, unable to follow-up at the specified intervals, allergic to the therapy of preference, or have an organism that is not amenable to oral antibiotic therapy.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Rush University Medical Center
Chicago, Illinois, 60607
Vanderbilt
Nashville, Tennessee, 37232
Rothman Institute
Philadelphia, Pennsylvania, 19107
Central DuPage Hospital
Winfield, Illinois, 60190
About this study
Official title: The Utility of Oral Antibiotic Therapy Following 2-stage Revision Arthroplasty for Infected Prosthetic Hips and Knees
The primary purpose of this study is to compare the re-infection rates in patients undergoing 2-stage revision arthroplasty who receive additional oral antibiotic therapy to those patients who received in-hospital perioperative antibiotic only. Patients will be monitored for re-infection following hospital discharge, defined as deep infection of the joint space/capsule that requires return to the operating room within 24-months of the re-implantation procedure.
- Conditions
- Prosthesis-Related Infections
- Being tested
- Oral Antibiotics
- Keywords
- Revision, Knee, Hip, Arthroplasty, Oral, Antibiotics, Infection
- Medical subject headings
- Prosthesis-Related Infections, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral AntibioticsOther
Oral Antibiotics will be prescribed for 3 months per recommendations of an infectious disease specialist.
| Study group | Role | What they receive |
|---|---|---|
| Oral Antibiotics | Experimental | Oral antibiotics for 3 months; recommendation for antibiotics will be made by an infectious disease specialist. Receives: Other: Oral Antibiotics |
| No oral antibiotics | No intervention | No oral antibiotics. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infection Rate
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2013 (estimated)
- Study startJul 2011
- Primary completionAug 2020
- Study completion23 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prosthesis-Related InfectionsStudies 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
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Craig J Della Valle, MD, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01760863
- Sponsor's protocol ID
- 11040802
- Status last verified
- Aug 2021
- First submitted
- 2 Jan 2013
- Last updated
- 25 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Zywiel MG, Johnson AJ, Stroh DA, Martin J, Marker DR, Mont MA. Prophylactic oral antibiotics reduce reinfection rates following two-stage revision total knee arthroplasty. Int Orthop. 2011 Jan;35(1):37-42. doi: 10.1007/s00264-010-0992-x. Epub 2010 Mar 7.
PubMed 20213514
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utility of Oral Antibiotic Therapy Following 2-stage Revision Arthroplasty for Infected Prosthetic Hips and Knees
- ClinicalTrials.gov ID
- NCT01760863
- Acronym / sponsor ID
- 11040802
- Conditions
- Prosthesis-Related Infections
- Keywords
- Revision, Knee, Hip, Arthroplasty, Oral, Antibiotics, Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- Jul 2011 (actual)
- Primary completion
- Aug 2020 (actual)
- Study completion
- 23 Sep 2020 (actual)
- First posted
- 4 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to compare the re-infection rates in patients undergoing 2-stage revision arthroplasty who receive additional oral antibiotic therapy to those patients who received in-hospital perioperative antibiotic only. Patients will be monitored for re-infection following hospital discharge, defined as deep infection of the joint space/capsule that requires return to the operating room within 24-months of the re-implantation procedure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Antibiotics | Experimental | Other: Oral AntibioticsOral antibiotics for 3 months; recommendation for antibiotics will be made by an infectious disease specialist. |
| No oral antibiotics | No intervention | –No oral antibiotics. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients undergoing 2-stage revision arthroplasty of the knee or hip with the causative organism(s) identified using tissue culture and/or joint fluid analysis that is amenable to oral antibiotic therapy. Patients must be able to tolerate oral antibiotics and agree to participate in the study.
Key exclusion criteria (1 listed)
- Patients with a fungal prosthetic joint infection, unable to tolerate or refuse to undergo oral antibiotic therapy, unable to follow-up at the specified intervals, allergic to the therapy of preference, or have an organism that is not amenable to oral antibiotic therapy.
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 |
|---|---|---|
| Oral AntibioticsOral Antibiotics will be prescribed for 3 months per recommendations of an infectious disease specialist. | Other | Oral Antibiotics |
Primary outcome
Infection Rate
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
- Results publication: PubMed 20213514Zywiel MG, Johnson AJ, Stroh DA, Martin J, Marker DR, Mont MA. Prophylactic oral antibiotics reduce reinfection rates following two-stage revision total knee arthroplasty. Int Orthop. 2011 Jan;35(1):37-42. doi: 10.1007/s00264-010-0992-x. Epub 2010 Mar 7.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Antibiotics in people with Prosthesis-Related Infections, run by Rush University Medical Center at 4 sites 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 1 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 25 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Infection Rate (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01760863, which also lists 1 linked publication.
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 25 Aug 2021.