Periprosthetic Joint Infection (PJI)Phase 2PJINCT07599865
Periprosthetic Joint Infection Bubble Study
A Phase 2 study testing Ultrasound-triggered microbubble destruction with antibiotics in people with Periprosthetic Joint Infection (PJI), run by Thomas Jefferson University at 3 sites in United States.
Trial summary
Patients with an infected knee replacement will receive their standard of care surgical treatment of the infection, with and without additional ultrasound microbubble treatment (randomly divided 50/50 in the active and control groups). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periprosthetic Joint Infection (PJI)
- What is being tested?
- Ultrasound-triggered microbubble destruction with antibiotics
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesUnited States
- Study dates
- 13 Aug 2026to 1 Jun 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Be at least 18 years of age
- Be medically stable
- If female of child-bearing potential, must have a negative pregnancy test
- Be conscious and able to comply with study procedures
- Have read and signed the IRB-approved Informed Consent form for participating in the study
- For Cohort 1, be scheduled for one- or two-stage exchange arthroplasty revision surgery for PJI of the knee
- For Cohort 2, be scheduled for DAIR revision surgery for PJI of the knee
Who cannot join
- Females who are pregnant or nursing
- Patients currently on chemotherapy requiring systemic infusion treatment
- Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable
- Patients with a history of anaphylactic allergy to perflutren or any other components of Definity
- Patients with a history of failed one- or two-stage revision for infection
- Patients for which placement of a surgical drain is contraindicated
- Patients in protected classes (e.g., prisoners)
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Not yet recruiting
UT Southwestern Medical Center
Dallas, Texas, 75390
Jonathan Thompson, 214-645-1620, jonathan.thompson@utsouthwestern.edu
Antonia Chen, MD
- Recruiting
Thomas Jefferson University/Rothman Institute
Philadelphia, Pennsylvania, 19107
Edsel Mangubat, MBA, MSN, RN, 267-386-5480, Edsel.mangubat@jefferson.edu
Lauren Delaney, PhD
- Not yet recruiting
University of Pittsburgh Medical Center (UPMC)
Pittsburgh, Pennsylvania, 15213
Dana Farrell, 412-641-3156, djf52@pitt.edu
Kenneth Urish, MD, PhD
About this study
Official title: Using Ultrasound and Microbubbles to Augment Antibiotic Efficiency Against Periprosthetic Joint Infections
Patients with an infected knee replacement will receive their standard of care surgical treatment of the infection, with and without additional ultrasound microbubble treatment (randomly divided 50/50 in the active and control groups). Subjects in the active group will receive a local bolus injection of antibiotics and ultrasound-active microbubbles within 24 hours of their revision surgery. The fundamental hypothesis is that a decrease in re-infection rates of at least 24% can be achieved in the active group relative to controls.
- Conditions
- Periprosthetic Joint Infection (PJI)
- Being tested
- Ultrasound-triggered microbubble destruction with antibiotics
- Keywords
- Periprosthetic knee infection, ultrasound-triggered microbubble destruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-triggered microbubble destruction with antibioticsDrug
Also called antibiotics, ultrasound-triggered microbubble destruction
A combination of Definity microbubbles and clinically-relevant antibiotics will in injected into the intraarticular space of the knee the day after revision surgery. Ultrasound will be used to rupture the microbubbles to enhance antibiotic activity.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 Exchange anthroplasty - experimental group | Experimental | The experimental group will undergo an US exam within 24 hours following the revision surgery with a Logiq E10 scanner (GE HealthCare), with a B-mode scan to acquire the radiofrequency (RF) data for the quantitative H-scan analysis, and a contrast-enhanced US (CEUS) scan to perform the UTMD therapy. Following the B-mode scan, the wound site will be sterilized and subjects will receive a localized injection of antibiotics (determined by the orthopaedic surgeon based on intra-operative cultures) and Definity microbubbles to perform the UTMD therapy using commercially-available flash-replenishment sequences. Receives: Drug: Ultrasound-triggered microbubble destruction with antibiotics |
| Cohort 2 Debridement, antibiotics, and implant retention (DAIR) revision surgery - experimental | Experimental | The experimental group will undergo an US exam within 24 hours following the revision surgery with a Logiq E10 scanner (GE HealthCare), with a B-mode scan to acquire the radiofrequency (RF) data for the quantitative H-scan analysis, and a contrast-enhanced US (CEUS) scan to perform the UTMD therapy. Following the B-mode scan, the wound site will be sterilized and subjects will receive a localized injection of antibiotics (determined by the orthopaedic surgeon based on intra-operative cultures) and Definity microbubbles to perform the UTMD therapy using commercially-available flash-replenishment sequences. Receives: Drug: Ultrasound-triggered microbubble destruction with antibiotics |
| Cohort 1 Exchange anthroplasty - control group | No intervention | The control group will undergo clinical standard of care with no therapeutic interventions from the study team, only the collection of the wound exudate from the wound drain. |
| Cohort 2 Debridement, antibiotics, and implant retention (DAIR) revision surgery - control | No intervention | The control group will undergo clinical standard of care with no therapeutic interventions from the study team, only the collection of the wound exudate from the wound drain. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Re-Infection Rate
Rate of re-infection within 2 years post-intervention
Measured: 2 years
Secondary outcomes (2)
Time to Re-Infection
Time between initial intervention and presentation with re-infection
Measured: 2 years
Bacterial Debris
Measurement of bacterial debris present in would exudate from drains
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start13 Aug 2026
- Primary completion1 Jun 2029 (estimated)
- Study completion1 Jun 2030 (estimated)
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 Periprosthetic Joint Infection (PJI)Studies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- There are 2 cohorts based on the type of standard-of-care revision surgery a subject undergoes, DAIR or implant exchange. Within each cohort, there is a control arm and an experimental arm.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07599865
- Sponsor's protocol ID
- 2025-0492
- Other IDs
- 1R01AI187384-01
- Acronym
- PJI
- Status last verified
- Sep 2026
- First submitted
- 14 May 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified data will be shared upon request
Publications
Zhao N, Curry D, Evans RE, Isguven S, Freeman T, Eisenbrey JR, Forsberg F, Gilbertie JM, Boorman S, Hilliard R, Dastgheyb SS, Machado P, Stanczak M, Harwood M, Chen AF, Parvizi J, Shapiro IM, Hickok NJ, Schaer TP. Microbubble cavitation restores Staphylococcus aureus antibiotic susceptibility in vitro and in a septic arthritis model. Commun Biol. 2023 Apr 17;6(1):425. doi: 10.1038/s42003-023-04752-y.
PubMed 37069337
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Ultrasound and Microbubbles to Augment Antibiotic Efficiency Against Periprosthetic Joint Infections
- ClinicalTrials.gov ID
- NCT07599865
- Acronym / sponsor ID
- PJI / 2025-0492
- Conditions
- Periprosthetic Joint Infection (PJI)
- Keywords
- Periprosthetic knee infection, ultrasound-triggered microbubble destruction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 13 Aug 2026 (actual)
- Primary completion
- 1 Jun 2029 (estimated)
- Study completion
- 1 Jun 2030 (estimated)
- First posted
- 20 May 2026 (actual)
- 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.
Patients with an infected knee replacement will receive their standard of care surgical treatment of the infection, with and without additional ultrasound microbubble treatment (randomly divided 50/50 in the active and control groups). Subjects in the active group will receive a local bolus injection of antibiotics and ultrasound-active microbubbles within 24 hours of their revision surgery. The fundamental hypothesis is that a decrease in re-infection rates of at least 24% can be achieved in the active group relative to controls.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- There are 2 cohorts based on the type of standard-of-care revision surgery a subject undergoes, DAIR or implant exchange. Within each cohort, there is a control arm and an experimental arm.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 Exchange anthroplasty - experimental group | Experimental | Drug: Ultrasound-triggered microbubble destruction with antibioticsThe experimental group will undergo an US exam within 24 hours following the revision surgery with a Logiq E10 scanner (GE HealthCare), with a B-mode scan to acquire the radiofrequency (RF) data for the quantitative H-scan analysis, and a contrast-enhanced US (CEUS) scan to perform the UTMD therapy. Following the B-mode scan, the wound site will be sterilized and subjects will receive a localized injection of antibiotics (determined by the orthopaedic surgeon based on intra-operative cultures) and Definity microbubbles to perform the UTMD therapy using commercially-available flash-replenishment sequences. |
| Cohort 2 Debridement, antibiotics, and implant retention (DAIR) revision surgery - experimental | Experimental | Drug: Ultrasound-triggered microbubble destruction with antibioticsThe experimental group will undergo an US exam within 24 hours following the revision surgery with a Logiq E10 scanner (GE HealthCare), with a B-mode scan to acquire the radiofrequency (RF) data for the quantitative H-scan analysis, and a contrast-enhanced US (CEUS) scan to perform the UTMD therapy. Following the B-mode scan, the wound site will be sterilized and subjects will receive a localized injection of antibiotics (determined by the orthopaedic surgeon based on intra-operative cultures) and Definity microbubbles to perform the UTMD therapy using commercially-available flash-replenishment sequences. |
| Cohort 1 Exchange anthroplasty - control group | No intervention | –The control group will undergo clinical standard of care with no therapeutic interventions from the study team, only the collection of the wound exudate from the wound drain. |
| Cohort 2 Debridement, antibiotics, and implant retention (DAIR) revision surgery - control | No intervention | –The control group will undergo clinical standard of care with no therapeutic interventions from the study team, only the collection of the wound exudate from the wound drain. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Be at least 18 years of age
- Be medically stable
- If female of child-bearing potential, must have a negative pregnancy test
- Be conscious and able to comply with study procedures
- Have read and signed the IRB-approved Informed Consent form for participating in the study
Key exclusion criteria (7 listed)
- Females who are pregnant or nursing
- Patients currently on chemotherapy requiring systemic infusion treatment
- Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable
- Patients with a history of anaphylactic allergy to perflutren or any other components of Definity
- Patients with a history of failed one- or two-stage revision for infection
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 |
|---|---|---|
| Ultrasound-triggered microbubble destruction with antibioticsAlso: antibiotics, ultrasound-triggered microbubble destructionA combination of Definity microbubbles and clinically-relevant antibiotics will in injected into the intraarticular space of the knee the day after revision surgery. Ultrasound will be used to rupture the microbubbles to enhance antibiotic activity. | Drug | Cohort 1 Exchange anthroplasty - experimental group, Cohort 2 Debridement, antibiotics, and implant retention (DAIR) revision surgery - experimental |
Primary outcome
Re-Infection Rate
Time frame: 2 years
Rate of re-infection within 2 years post-intervention
2 secondary outcomes
Time to Re-Infection
Time frame: 2 years
Bacterial Debris
Time frame: 72 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Background: PubMed 37069337Zhao N, Curry D, Evans RE, Isguven S, Freeman T, Eisenbrey JR, Forsberg F, Gilbertie JM, Boorman S, Hilliard R, Dastgheyb SS, Machado P, Stanczak M, Harwood M, Chen AF, Parvizi J, Shapiro IM, Hickok NJ, Schaer TP. Microbubble cavitation restores Staphylococcus aureus antibiotic susceptibility in vitro and in a septic arthritis model. Commun Biol. 2023 Apr 17;6(1):425. doi: 10.1038/s42003-023-04752-y.
- Individual participant dataSharing planned: Undecided. De-identified data will be shared upon request
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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.
Thomas Jefferson University/Rothman Institute
Philadelphia, United States
3 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 Ultrasound-triggered microbubble destruction with antibiotics in people with Periprosthetic Joint Infection (PJI), run by Thomas Jefferson University at 3 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 7 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Re-Infection Rate (time frame: 2 years). 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 NCT07599865, 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 23 Sep 2026.