New injection could fight stubborn joint infections after knee surgery
NCT ID NCT06889701
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial tests a new drug called TNP-2092, given as an injection into the knee joint, for people with infections after knee replacement surgery. The study includes 33 participants and compares the new drug to standard antibiotics. The main goal is to check safety and how the drug behaves in the body, not yet to prove it works.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- TNP-2092 (rifaquizinone) injection
- What this could lead to
- If it works, this could offer a new treatment option for stubborn joint infections after knee replacement, potentially reducing the need for long-term antibiotics.
- What could go wrong
- This is a very early phase 1/2 study with only 33 participants, so it is too soon to know if it works. The main focus is safety, and there may be side effects or no benefit.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 33 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion 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 joint replacements and revision surgeries) did not meet the clinical cure criteria and requiring long-term antibiotic suppression therapy as judged by investigators before enrollment. * 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 investigator. * 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 end-of-study visit. Male participants must refrain from donating sperm during this period. Exclusion Criteria: * 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 interpretation of study results, including but not limited to active malignancy, metabolic disease, alcohol or drug abuse, or clinically significant laboratory abnormalities. * Presence of serious liver, blood, or immune system disorders as evidenced by the following: 1. Acute hepatitis of any cause within the past year. 2. Serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin levels \> 2 times the upper limit of normal (ULN). 3. Presence of end-stage liver disease-related manifestations such as ascites or hepatic encephalopathy. 4. Current or anticipated neutropenia (ie, neutrophil count \< 0.5 x 10\^9/L). 5. Chemotherapy for cancer, radiation therapy, or potent noncorticosteroid immunosuppressants (eg, cyclosporine, azathioprine, tacrolimus, immunomodulatory monoclonal antibody therapy, etc) within the past 3 months or corticosteroids (≥ 40 mg prednisone/day) for more than 14 days within 30 days prior to randomization. * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The First Affiliated Hospital of Xinjiang Medical University
RECRUITINGÜrümqi, Xinjiang, China
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