Safety and Efficacy in Patients Treated for Hip or Knee PJI With Vancomycin and Tobramycin Joint Irrigation

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.

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Key information

Conditions

Prosthetic Joint Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Covenant Hospital, Saginaw, Michigan, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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)
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

Treatment and study plan

vancomycin hydrochloride and tobramycin sulfate

Combination Product

vancomycin hydrochloride and tobramycin sulfate via local irrigation

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Osteal Therapeutics, Inc.

Industry

Registry information

Official study 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

Important dates

Study start: 2018
Primary completion: 2020
Study completion: 2020
First posted: Oct 26, 2018
Registry last updated: Jan 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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