Prosthetic Joint Infection (PJI)Phase 2NCT07858916
A Phase 2b Study to Evaluate the Efficacy, Safety, and PK Profiles of TNP-2092 Administered Via IA Injection in PJI Participants
A Phase 2 study testing TNP-2092 for injection, Vancomycin Hydrochloride for Injection and Oral antibiotics in people with Prosthetic Joint Infection (PJI), run by TenNor Therapeutics (Zhongshan) Limited at 1 site in China.
Trial summary
This is a Phase 2b, randomized, controlled, open-label clinical study evaluating the efficacy, safety, and local PK profiles of TNP-2092 administered via IA injection on a background of antibiotic treatment in participants with early postoperative (within 3 months after index arthroplasty) or acute hematogenous… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Prosthetic Joint Infection (PJI)
- What is being tested?
- TNP-2092 for injection, Vancomycin Hydrochloride for Injection and Oral antibiotics
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Oct 2026to Mar 2028
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants with PJI that is early postoperatively (within 3 months of index arthroplasty) or acute hematogenous (within 4 weeks of infectious symptoms) after knee arthroplasty; or participants with chronic PJI requiring long-term antibiotic suppressive therapy (including PJI occurring after any type of joint arthroplasty or revision arthroplasty).
- PJI that, in the investigator's judgment, is suspected or confirmed to be caused by Gram-positive bacteria.
- Agrees to receive local IA injection of TNP-2092.
- Age ≥18 years and ≤80 years at the time of signing the informed consent form (ICF), regardless of sex.
- The implanted joint prosthesis is well fixed.
- No sinus tract in the affected joint.
- Body mass index (BMI) ≥18 kg/m² and ≤40 kg/m².
- Female participants who are of childbearing potential and those who are <2 years postmenopausal and have not been permanently sterilized must have a negative pregnancy test at baseline and agree to voluntarily use effective contraception from the time of signing the ICF until 8 weeks after the last study treatment. Female participants who are not of childbearing potential (i.e., have undergone tubal ligation, hysterectomy, or bilateral oophorectomy, or are ≥2 years postmenopausal) or whose partner has undergone a vasectomy do not need to use contraception. If a male participant's female partner is of childbearing potential, the male participant must agree to voluntarily use effective contraception and must avoid donating sperm from the time of signing the ICF until 8 weeks after the last study treatment.
Who cannot join
- Known history of hypersensitivity or intolerance to any of the following medications: vancomycin or TNP-2092.
- Confirmed PJI caused by Gram-positive bacteria mixed with other pathogens, or PJI caused solely by fungi, mycobacteria, or Gram-negative bacteria infection.
- Documented sepsis or septicemia.
- Life expectancy of less than 1 year.
- Female participants who are pregnant or breastfeeding.
- Any surgical or medical condition that, in the investigator's opinion, may affect the participant's ability to participate in the study, affect administration of the investigational product, or affect interpretation of the study results, including but not limited to active malignancy, metabolic disease, alcohol or drug abuse, or clinically significant laboratory abnormalities.
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- Presence of severe hepatic, hematologic, or immune system disease, as evidenced by any of the following:
- a Acute hepatitis of any cause within the past year.
- b Serum alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 2 × upper limit of normal (ULN), or total bilirubin > 1.5 × ULN.
- c Manifestations associated with end-stage liver disease, such as ascites or hepatic encephalopathy.
- d Current or anticipated neutropenia (i.e., neutrophil count < 0.5 × 10⁹/L).
- e Receipt of cancer chemotherapy, radiotherapy, or potent non-corticosteroid immunosuppressants (e.g., cyclosporine, azathioprine, tacrolimus, immunomodulatory monoclonal antibody therapy, etc.) within the past 3 months, or receipt of corticosteroid therapy for more than 14 days (≥40 mg prednisone/day) within 30 days before enrollment; or participants expected to require immunosuppressive therapy during the study.
- Positive HIV antibody results during screening.
- History of severe renal disease or evidence of such disease, or creatinine clearance < 30 mL/min calculated using the Cockcroft-Gault formula.
- Receipt of another investigational drug within 30 days or 5 half-lives (whichever is longer) before the first dose of the investigational product in this study, or participation in a medical device clinical study.
- In the investigator's opinion, the participant is unable to comply with the protocol and investigational product administration procedures or to complete the clinical study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang
Li Cao, +86 991-4366553, xjbone@sina.com
About this study
Official title: A Phase 2b, Randomized, Controlled, Open-label Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) Profiles of TNP-2092 Administered Via Intra-articular (IA) Injection on a Background of Antibiotic Treatment in Adult Participants With Early Postoperative or Acute Hematogenous Prosthetic Joint Infection (PJI) After Knee Arthroplasty, Without Debridement, or in Participants With Chronic PJI Requiring Long-term Antibiotic Suppressive Treatment.
This is a Phase 2b, randomized, controlled, open-label clinical study evaluating the efficacy, safety, and local PK profiles of TNP-2092 administered via IA injection on a background of antibiotic treatment in participants with early postoperative (within 3 months after index arthroplasty) or acute hematogenous (within 4 weeks of infection) PJI after knee arthroplasty, without debridement, and in participants with chronic PJI (including PJI occurring after various joint arthroplasties and revision arthroplasties) requiring long-term antibiotic suppressive treatment.
Read the detailed description
The study population comprises participants with early postoperative (within 3 months of index arthroplasty) or acute hematogenous (within 4 weeks of infection symptoms) PJI after knee arthroplasty, or participants with chronic PJI requiring long-term antibiotic suppressive treatment (including PJI occurring after various joint arthroplasties and revision arthroplasties).
- Conditions
- Prosthetic Joint Infection (PJI)
- Being tested
- TNP-2092 for injection, Vancomycin Hydrochloride for Injection, Oral antibiotics, Appropriate intravenous and/or oral antibiotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TNP-2092 for injectionDrug
Also called rifaquizinone for injection
Starting on D1, administer by intra-articular injection either once daily or once weekly. Participants in Arm A will receive once-daily dosing for 14 days, and participants in Arm B and Arm C will receive once-weekly dosing for 4 weeks. Doses should be administered at approximately the same time whenever possible (no more than 1 hour earlier or later than the time of the first dose).
Vancomycin Hydrochloride for InjectionDrug
Participants receive empiric treatment with vancomycin 1 g administered via IV infusion every 12 hours (q12h). For participants aged 65 years or older, the vancomycin dose may be adjusted to 0.5 g q12h; during the study, it may also be adjusted according to renal function.
Oral antibioticsDrug
After 14 days of IV infusion, participants who meet the criteria for IV to oral switch may switch to oral antibiotic treatment (minocycline or levofloxacin, as determined by the investigator). After 7 days of IV infusion, if IV administration cannot be continued due to tolerability or other reasons, participants may also switch to oral antibiotic treatment if they meet the criteria for IV to oral switch. Oral treatment lasts 56-63 days and combined IV plus oral treatment lasts a total of 10 weeks (70 days).
- Levofloxacin tablets: 0.5 g (1 tablet) orally once daily, taken within 1 hour before breakfast, for 56-63 days.
- Minocycline hydrochloride capsules: administered orally twice daily; the first dose is 200 mg (2 capsules), and all subsequent doses are 100 mg (1 capsule), for 56-63 days.
Appropriate intravenous and/or oral antibioticsDrug
The investigator will select appropriate intravenous and/or oral antibiotics based on the participant's condition and with reference to domestic and international guidelines, to be continued for 10 weeks (70 days).
| Study group | Role | What they receive |
|---|---|---|
| Arm A (TNP-2092 IA once daily for 14 days) | Experimental | TNP-2092 for injection, intra-articular(IA) administration , 50 mg once daily for 14 days Receives: Drug: TNP-2092 for injection; Drug: Vancomycin Hydrochloride for Injection; Drug: Oral antibiotics |
| Arm B (TNP-2092 IA once weekly for 4 weeks) | Experimental | TNP-2092 for injection, intra-articular(IA) administration , 50 mg once weekly for 4 weeks Receives: Drug: TNP-2092 for injection; Drug: Vancomycin Hydrochloride for Injection; Drug: Oral antibiotics |
| Arm C (chronic PJI) | Experimental | TNP-2092 for injection, intra-articular(IA) administration , 50 mg once weekly for 4 weeks Receives: Drug: TNP-2092 for injection; Drug: Appropriate intravenous and/or oral antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment failure rate
Participants will be considered as treatment failures if any of the following criteria are met:
- Failure to meet the intravenous (IV) to oral switch criteria at the end of background intravenous treatment (only for early postoperative or acute hematogenous PJI participants)
- The end of IA treatment (EOIA) assessment is non-response.
- The end of treatment(EOT) assessment is non- response.
- Requiring surgical treatment or systemic antibiotic treatment beyond the study regimen for the primary infected joint during the study.
- Death due to the primary joint infection.
Measured: Within 6 months after the initiation of study treatment
Secondary outcomes (5)
Treatment failure rate
Measured: Within 12 months after the initiation of study treatment
End of IA treatment (EOIA) response rate
Participants will be considered as responders if the following criterion is met:
a Evaluation of the primary infection site shows improvement compared to baseline, defined as improvement in pain, erythema, edema, or wound drainage in the infected joint. Specifically, improvement in pain is defined as a pain score lower than baseline or ≤3 points.
Measured: On day 15 (D15) for participants receiving daily TNP-2092 dosing, on D29 for participants receiving weekly TNP-2092 dosing
End of treatment (EOT) response rate
Participants will be considered as responders if all of the following criteria are met:
a Serum C-reactive protein (CRP) ≤ 10 mg/L, or lower than baseline level and ≤ 20 mg/L.
b Joint pain resolved (numeric rating scale score lower than baseline) or tolerable (numeric rating scale score 0-3 points).
c The score of injected joint function scale is higher than baseline.
Measured: On Day71
Adverse Events (AEs)
An Adverse Event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug.
Measured: Day 1 to Day 361
Concentrations of TNP-2092 in synovial fluid
Synovial fluid concentrations of TNP-2092 were measured by a specific and validated assay.
Measured: Arm A: collected within 1 hour before administration on Day 2, Day 7, and Day 14; Arm B and Arm C: collected within 1 hour before administration on Day 8, Day 15, and Day 22.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthetic 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
- Eligible participants diagnosed with early postoperative or acute hematogenous PJI after knee arthroplasty will be randomized 1:1 to Arm A (TNP-2092 IA once daily for 14 days) and Arm B (TNP-2092 IA once weekly for 4 weeks), with 10 participants per arm; participants with chronic PJI requiring long-term antibiotic suppressive therapy (including PJI occurring after various joint arthroplasties and revision arthroplasties) will be assigned to Arm C (TNP-2092 IA once weekly for 4 weeks), with a maximum of 20 participants.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TenNor Therapeutics (Zhongshan) Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07858916
- Sponsor's protocol ID
- TNP-2092-IA-02
- Status last verified
- Sep 2026
- First submitted
- 29 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b, Randomized, Controlled, Open-label Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) Profiles of TNP-2092 Administered Via Intra-articular (IA) Injection on a Background of Antibiotic Treatment in Adult Participants With Early Postoperative or Acute Hematogenous Prosthetic Joint Infection (PJI) After Knee Arthroplasty, Without Debridement, or in Participants With Chronic PJI Requiring Long-term Antibiotic Suppressive Treatment.
- ClinicalTrials.gov ID
- NCT07858916
- Acronym / sponsor ID
- TNP-2092-IA-02
- Conditions
- Prosthetic Joint Infection (PJI)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- TenNor Therapeutics (Zhongshan) LimitedIndustry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 5 Oct 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.
This is a Phase 2b, randomized, controlled, open-label clinical study evaluating the efficacy, safety, and local PK profiles of TNP-2092 administered via IA injection on a background of antibiotic treatment in participants with early postoperative (within 3 months after index arthroplasty) or acute hematogenous (within 4 weeks of infection) PJI after knee arthroplasty, without debridement, and in participants with chronic PJI (including PJI occurring after various joint arthroplasties and revision arthroplasties) requiring long-term antibiotic suppressive treatment.
Detailed description
The study population comprises participants with early postoperative (within 3 months of index arthroplasty) or acute hematogenous (within 4 weeks of infection symptoms) PJI after knee arthroplasty, or participants with chronic PJI requiring long-term antibiotic suppressive treatment (including PJI occurring after various joint arthroplasties and revision arthroplasties).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Eligible participants diagnosed with early postoperative or acute hematogenous PJI after knee arthroplasty will be randomized 1:1 to Arm A (TNP-2092 IA once daily for 14 days) and Arm B (TNP-2092 IA once weekly for 4 weeks), with 10 participants per arm; participants with chronic PJI requiring long-term antibiotic suppressive therapy (including PJI occurring after various joint arthroplasties and revision arthroplasties) will be assigned to Arm C (TNP-2092 IA once weekly for 4 weeks), with a maximum of 20 participants.
| Arm | Type | Receives |
|---|---|---|
| Arm A (TNP-2092 IA once daily for 14 days) | Experimental | Drug: TNP-2092 for injection, Drug: Vancomycin Hydrochloride for Injection, Drug: Oral antibioticsTNP-2092 for injection, intra-articular(IA) administration , 50 mg once daily for 14 days |
| Arm B (TNP-2092 IA once weekly for 4 weeks) | Experimental | Drug: TNP-2092 for injection, Drug: Vancomycin Hydrochloride for Injection, Drug: Oral antibioticsTNP-2092 for injection, intra-articular(IA) administration , 50 mg once weekly for 4 weeks |
| Arm C (chronic PJI) | Experimental | Drug: TNP-2092 for injection, Drug: Appropriate intravenous and/or oral antibioticsTNP-2092 for injection, intra-articular(IA) administration , 50 mg once weekly for 4 weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participants with PJI that is early postoperatively (within 3 months of index arthroplasty) or acute hematogenous (within 4 weeks of infectious symptoms) after knee arthroplasty; or participants with chronic PJI requiring long-term antibiotic suppressive therapy (including PJI occurring after any type of joint arthroplasty or revision arthroplasty).
- PJI that, in the investigator's judgment, is suspected or confirmed to be caused by Gram-positive bacteria.
- Agrees to receive local IA injection of TNP-2092.
- Age ≥18 years and ≤80 years at the time of signing the informed consent form (ICF), regardless of sex.
- The implanted joint prosthesis is well fixed.
Key exclusion criteria (16 listed)
- Known history of hypersensitivity or intolerance to any of the following medications: vancomycin or TNP-2092.
- Confirmed PJI caused by Gram-positive bacteria mixed with other pathogens, or PJI caused solely by fungi, mycobacteria, or Gram-negative bacteria infection.
- Documented sepsis or septicemia.
- Life expectancy of less than 1 year.
- Female participants who are pregnant or breastfeeding.
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 |
|---|---|---|
| TNP-2092 for injectionAlso: rifaquizinone for injectionStarting on D1, administer by intra-articular injection either once daily or once weekly. Participants in Arm A will receive once-daily dosing for 14 days, and participants in Arm B and Arm C will receive once-weekly dosing for 4 weeks. Doses should be administered at approximately the same time whenever possible (no more than 1 hour earlier or later than the time of the first dose). | Drug | Arm A (TNP-2092 IA once daily for 14 days), Arm B (TNP-2092 IA once weekly for 4 weeks), Arm C (chronic PJI) |
| Vancomycin Hydrochloride for InjectionParticipants receive empiric treatment with vancomycin 1 g administered via IV infusion every 12 hours (q12h). For participants aged 65 years or older, the vancomycin dose may be adjusted to 0.5 g q12h; during the study, it may also be adjusted according to renal function. | Drug | Arm A (TNP-2092 IA once daily for 14 days), Arm B (TNP-2092 IA once weekly for 4 weeks) |
| Oral antibioticsAfter 14 days of IV infusion, participants who meet the criteria for IV to oral switch may switch to oral antibiotic treatment (minocycline or levofloxacin, as determined by the investigator). After 7 days of IV infusion, if IV administration cannot be continued due to tolerability or other reasons, participants may also switch to oral antibiotic treatment if they meet the criteria for IV to oral switch. Oral treatment lasts 56-63 days and combined IV plus oral treatment lasts a total of 10 weeks (70 days). * Levofloxacin tablets: 0.5 g (1 tablet) orally once daily, taken within 1 hour before breakfast, for 56-63 days. * Minocycline hydrochloride capsules: administered orally twice daily; the first dose is 200 mg (2 capsules), and all subsequent doses are 100 mg (1 capsule), for 56-63 days. | Drug | Arm A (TNP-2092 IA once daily for 14 days), Arm B (TNP-2092 IA once weekly for 4 weeks) |
| Appropriate intravenous and/or oral antibioticsThe investigator will select appropriate intravenous and/or oral antibiotics based on the participant's condition and with reference to domestic and international guidelines, to be continued for 10 weeks (70 days). | Drug | Arm C (chronic PJI) |
Primary outcome
Treatment failure rate
Time frame: Within 6 months after the initiation of study treatment
Participants will be considered as treatment failures if any of the following criteria are met: * Failure to meet the intravenous (IV) to oral switch criteria at the end of background intravenous treatment (only for early postoperative or acute hematogenous PJI participants) * The end of IA treatment (EOIA) assessment is non-response. * The end of treatment(EOT) assessment is non- response. * Requiring surgical treatment or systemic antibiotic treatment beyond the study regimen for the primary infected joint during the study. * Death due to the primary joint infection.
5 secondary outcomes
Treatment failure rate
Time frame: Within 12 months after the initiation of study treatment
End of IA treatment (EOIA) response rate
Time frame: On day 15 (D15) for participants receiving daily TNP-2092 dosing, on D29 for participants receiving weekly TNP-2092 dosing
End of treatment (EOT) response rate
Time frame: On Day71
Adverse Events (AEs)
Time frame: Day 1 to Day 361
Concentrations of TNP-2092 in synovial fluid
Time frame: Arm A: collected within 1 hour before administration on Day 2, Day 7, and Day 14; Arm B and Arm C: collected within 1 hour before administration on Day 8, Day 15, and Day 22.
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 5 Oct 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TNP-2092 for injection, Vancomycin Hydrochloride for Injection and Oral antibiotics in people with Prosthetic Joint Infection (PJI), run by TenNor Therapeutics (Zhongshan) Limited at 1 site in China.
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 8 inclusion and 16 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: opening soon, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Contact Cao Li (+86 991-4366553, xjbone@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment failure rate (time frame: Within 6 months after the initiation of study treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Oct 2026.