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Tests treatment safety and results for Periprosthetic Joint Infection (PJI)
Official title A Phase 1/2 Study to Evaluate the Safety, PK and Efficacy of TNP-2092 Administered Via IA Injection in PJI Participants
ClinicalTrials.gov ID: NCT06889701
What this study is testing
What is TNP-2092 for injection?
TNP-2092 for injection is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for periprosthetic joint infection (pji).
Also referred to as rifaquizinone for injection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase 1/2, randomized, controlled, open-label, proof-of-concept study to evaluate the safety and tolerability, local and systemic PK profiles of TNP-2092 administered via IA injection on the basis of vancomycin IV and oral antibiotics therapy in participants with early (within 1 month of TKA) or acute hematogenous (within 3 weeks of infectious symptoms) PJI requiring or not requiring DAIR therapy after TKA, or requiring long-term antibiotic suppression therapy for PJI (including PJI occurring after various joint replacements and revision surgeries).
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Early (within 1 month of TKA) or acute hematogenous (within 3 weeks of infectious symptoms) PJI requires or does not require DAIR therapy after TKA...
- Suspected or confirmed PJI was caused by a Gram-positive bacterial infection, including methicillin-resistant and ciprofloxacin-resistant...
- Agree to be hospitalized for 2 weeks with local intra-articular injection.
- 18 years of age or older (of either sex) at the time of signing the informed consent form (ICF).
- The implanted prosthetic joint was well fixed.
You likely can't join if
- History of hypersensitivity or intolerance to any of the following agents: vancomycin or TNP-2092.
- Definite PJI of Gram-negative infection, fungal infection, or Enterococcus infection, or Mycobacterium infection, or Gram-positive mixed...
- Definite systemic infection (sepsis).
- Expected survival less than 1 years.
- Female participant is pregnant, lactating, or has a positive screening/baseline pregnancy test.
- Surgical or medical conditions that, in the opinion of the investigator, could affect the participant's ability to participate in the study, or...
See the full eligibility criteria
- Early (within 1 month of TKA) or acute hematogenous (within 3 weeks of infectious symptoms) PJI requires or does not require DAIR therapy after TKA, or results of treatment for PJI (including PJI occurring after various...
- Suspected or confirmed PJI was caused by a Gram-positive bacterial infection, including methicillin-resistant and ciprofloxacin-resistant Staphylococcus aureus and Staphylococcus epidermidis, as judged by the...
- Agree to be hospitalized for 2 weeks with local intra-articular injection.
- 18 years of age or older (of either sex) at the time of signing the informed consent form (ICF).
- The implanted prosthetic joint was well fixed.
- No sinus tract that communicates with the prosthesis.
- Body mass index (BMI) ≥ 18 kg/m\^2 and ≤ 34 kg/m\^2.
- Agree to voluntarily use effective contraception from signing the ICF through 8 weeks after the last dose of investigational product (in case of premature withdrawal from the study) or through completion of the...
- History of hypersensitivity or intolerance to any of the following agents: vancomycin or TNP-2092.
- Definite PJI of Gram-negative infection, fungal infection, or Enterococcus infection, or Mycobacterium infection, or Gram-positive mixed Gram-negative and/or fungal infection.
- Definite systemic infection (sepsis).
- Expected survival less than 1 years.
- Female participant is pregnant, lactating, or has a positive screening/baseline pregnancy test.
- Surgical or medical conditions that, in the opinion of the investigator, could affect the participant's ability to participate in the study, or affect the administration of investigational product, or affect the...
- Presence of serious liver, blood, or immune system disorders as evidenced by the following:
- Acute hepatitis of any cause within the past year.
- Serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin levels \> 2 times the upper limit of normal (ULN).
- Presence of end-stage liver disease-related manifestations such as ascites or hepatic encephalopathy.
- Current or anticipated neutropenia (ie, neutrophil count \< 0.5 x 10\^9/L).
- Chemotherapy for cancer, radiation therapy, or potent noncorticosteroid immunosuppressants (eg, cyclosporine, azathioprine, tacrolimus, immunomodulatory monoclonal antibody therapy, etc) within the past 3 months or...
- Positive AIDS antibody screening.
- History or evidence of severe renal disease or creatinine clearance \< 30 mL/min based on the Cockcroft-Gault formula.
- Treatment with an investigational agent within 30 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention.
- Participants who, in the opinion of the investigator, were unable to comply with the protocol and study drug administration procedures or complete the clinical study.
The study team makes the final eligibility decision.
Where it's taking place
- Ürümqi, Xinjiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ürümqi, Xinjiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.