Prosthetic Joint InfectionPhase 2NCT03721328
Safety and Efficacy in Patients Treated for Hip or Knee PJI With Vancomycin and Tobramycin Joint Irrigation
A Phase 2 study testing vancomycin hydrochloride and tobramycin sulfate in people with Prosthetic Joint Infection, run by Osteal Therapeutics, Inc. at 4 sites in United States.
Trial summary
Study Type Prospective, single-arm, open-label, multicenter (3 to 5 sites), interventional trial. Primary Study Objective The objective of the study is to determine the safety profile of local antibiotic irrigation for the treatment of PJI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prosthetic Joint Infection
- What is being tested?
- vancomycin hydrochloride and tobramycin sulfate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 4 sitesUnited States
- Study dates
- 26 Oct 2018to 25 Aug 2020
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years or greater
- Preoperative diagnosis of PJI of the hip or knee per the 2018 Definition of Periprosthetic Hip and Knee Infection
- Chronic PJI (symptoms lasting at least 4 weeks) per Tsukayama et al.
- Medical clearance for surgery
- Physical and mental ability and willingness to comply with the protocol, including the ability to read and complete required forms, and willingness and ability to adhere to the scheduled follow-up visits and requirements of the protocol
Who cannot join
- Late acute hematogenous infection per Tsukayama et al.
- Patients for whom a two-stage exchange arthroplasty is not indicated
- Sepsis
- Previously failed single- or two-stage revision arthroplasty for PJI (aseptic revision, polyethylene liner exchange, and/or irrigation and debridement with component retention is allowed)
- Patients with PJI of more than one joint
- Patients on chronic antibiotic therapy (≥ 6 months duration)
Show all 20Show fewer
- Patients who require therapeutic anticoagulation
- Patients on antiplatelet therapy for whom withholding antiplatelet therapy for any amount of time is contraindicated
- Patients with renal insufficiency/failure (serum creatinine ≥ 2.0 mg/dl)
- Patients with uncontrolled diabetes, defined as: hemoglobin A1C levels > 8.0%
- Patients on immunosuppressive therapy, chemotherapy for malignant disease, or glucocorticoid therapy (e.g. prednisone ≥ 10 mg/day).
- Patients with immunodeficiency (e.g., splenectomy; sickle cell anemia; Stage 3 HIV; primary humoral, bone marrow, or other transplantation.)
- Anticipated or potential patient relocation that may interfere with follow-up examinations
- Allergy to vancomycin HCl or tobramycin sulfate (Note: prior history of Red Man's syndrome is not considered an allergy)
- Patients who are pregnant or planning to become pregnant
- Patients in whom negative pressure wound therapy is contraindicated
- Patients infected with pathogens that are not considered susceptible to vancomycin HCl or tobramycin sulfate, as per the Investigator's opinion
- Breastfeeding at screening visit
- Patients who are prisoners
- Participation in another clinical trial of another Investigational Drug or Investigational Device within the past 30 days
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Ortho Carolina Research Institute
Charlotte, North Carolina, 28207
SSM Health Bone and Joint Hospital at St. Anthony
Oklahoma City, Oklahoma, 73103
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261
Covenant Hospital
Saginaw, Michigan, 48604
About this study
Official title: A Phase 2 Multicenter Feasibility Trial to Evaluate Safety and Efficacy in Patients Treated for Hip or Knee Prosthetic Joint Infection (PJI) With Alternating Irrigation of Vancomycin Hydrochloride (HCl) and Tobramycin Sulfate in Two-Stage Exchange Arthroplasty
Study Type
Prospective, single-arm, open-label, multicenter (3 to 5 sites), interventional trial.
Primary Study Objective
The objective of the study is to determine the safety profile of local antibiotic irrigation for the treatment of PJI.
Primary Outcome Measure
The overall safety profile is characterized by assessing the incidence of adverse events (AEs), serious adverse events (SAEs), suspected adverse reactions, adverse reactions, and unexpected adverse reactions.
Follow-up
Patients will be assessed for all measures at 3 weeks, 6 weeks, 12 weeks, and 12 months from initial surgery.
- Conditions
- Prosthetic Joint Infection
- Being tested
- vancomycin hydrochloride and tobramycin sulfate
- Keywords
- Hip, Knee, Biofilm, Minimum-biofilm-eradication-concentration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vancomycin hydrochloride and tobramycin sulfateCombination product
vancomycin hydrochloride and tobramycin sulfate via local irrigation
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Joint irrigation with vancomycin and tobramycin Receives: Combination Product: vancomycin hydrochloride and tobramycin sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Evaluations: Number and Frequency of Adverse Events Among Participants
The overall safety profile is characterized by assessing the incidence of adverse events (AEs), serious adverse events (SAEs), suspected adverse reactions, adverse reactions, and unexpected adverse reactions.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2018
- Study start26 Oct 2018
- Primary completion25 Aug 2020
- Study completion25 Aug 2020
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 Prosthetic Joint InfectionStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osteal Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bryan Springer, MD, Principal investigator, Ortho Carolina Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03721328
- Sponsor's protocol ID
- JPS-001
- Status last verified
- Dec 2021
- First submitted
- 17 Oct 2018
- Last updated
- 11 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Multicenter Feasibility Trial to Evaluate Safety and Efficacy in Patients Treated for Hip or Knee Prosthetic Joint Infection (PJI) With Alternating Irrigation of Vancomycin Hydrochloride (HCl) and Tobramycin Sulfate in Two-Stage Exchange Arthroplasty
- ClinicalTrials.gov ID
- NCT03721328
- Acronym / sponsor ID
- JPS-001
- Conditions
- Prosthetic Joint Infection
- Keywords
- Hip, Knee, Biofilm, Minimum-biofilm-eradication-concentration
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Osteal Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Oct 2018 (actual)
- Primary completion
- 25 Aug 2020 (actual)
- Study completion
- 25 Aug 2020 (actual)
- First posted
- 26 Oct 2018 (actual)
- Results
- Posted 9 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study Type
Prospective, single-arm, open-label, multicenter (3 to 5 sites), interventional trial.
Primary Study Objective
The objective of the study is to determine the safety profile of local antibiotic irrigation for the treatment of PJI.
Primary Outcome Measure
The overall safety profile is characterized by assessing the incidence of adverse events (AEs), serious adverse events (SAEs), suspected adverse reactions, adverse reactions, and unexpected adverse reactions.
Follow-up
Patients will be assessed for all measures at 3 weeks, 6 weeks, 12 weeks, and 12 months from initial surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Combination Product: vancomycin hydrochloride and tobramycin sulfateJoint irrigation with vancomycin and tobramycin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years or greater
- Preoperative diagnosis of PJI of the hip or knee per the 2018 Definition of Periprosthetic Hip and Knee Infection
- Chronic PJI (symptoms lasting at least 4 weeks) per Tsukayama et al.
- Medical clearance for surgery
- Physical and mental ability and willingness to comply with the protocol, including the ability to read and complete required forms, and willingness and ability to adhere to the scheduled follow-up visits and requirements of the protocol
Key exclusion criteria (20 listed)
- Late acute hematogenous infection per Tsukayama et al.
- Patients for whom a two-stage exchange arthroplasty is not indicated
- Sepsis
- Previously failed single- or two-stage revision arthroplasty for PJI (aseptic revision, polyethylene liner exchange, and/or irrigation and debridement with component retention is allowed)
- Patients with PJI of more than one joint
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 |
|---|---|---|
| vancomycin hydrochloride and tobramycin sulfatevancomycin hydrochloride and tobramycin sulfate via local irrigation | Combination product | Experimental |
Primary outcome
Safety Evaluations: Number and Frequency of Adverse Events Among Participants
Time frame: 12 months
The overall safety profile is characterized by assessing the incidence of adverse events (AEs), serious adverse events (SAEs), suspected adverse reactions, adverse reactions, and unexpected adverse reactions.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- 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.
Bryan Springer, MD principal investigator
Ortho Carolina Research Institute
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing vancomycin hydrochloride and tobramycin sulfate in people with Prosthetic Joint Infection, run by Osteal Therapeutics, Inc. 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 5 inclusion and 20 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 11 Jan 2022. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Dec 2021). 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?
Safety Evaluations: Number and Frequency of Adverse Events Among Participants (time frame: 12 months). 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 11 Jan 2022.