Periprosthetic Joint Infection Bubble Study

NCT07599865 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2025-04921R01AI187384-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

Brief 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). 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)

Keywords

Periprosthetic knee infection; ultrasound-triggered microbubble destruction

Outcome Measures

Primary Outcomes (1)

• Re-Infection Rate

  Rate of re-infection within 2 years post-intervention

  2 years

Secondary Outcomes (2)

• Time to Re-Infection

  2 years

• Bacterial Debris

  72 hours

Study Arms (4)

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.

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.

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.

Interventions

Ultrasound-triggered microbubble destruction with antibiotics DRUG

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.

Also known as: antibiotics, ultrasound-triggered microbubble destruction

Cohort 1 Exchange anthroplasty - experimental group; Cohort 2 Debridement, antibiotics, and implant retention (DAIR) revision surgery - experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Thomas Jefferson University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (3)

Thomas Jefferson University/Rothman Institute

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

University of Pittsburgh Medical Center (UPMC)

Pittsburgh, Pennsylvania, 15213, United States

NOT YET RECRUITING

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

NOT YET RECRUITING

Related Publications (1)

• 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.

  PMID: 37069337 BACKGROUND

MeSH Terms

Interventions

Anti-Bacterial Agents

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: May 20, 2026
• Study Start: June 30, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2030
• Last Updated: July 31, 2026

Record last verified: 2026-07

Locations

US (3)