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TNP-2092 to Treat Acute Bacterial Skin and Skin Structure Infection (P2_ABSSSI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03964493
Recruitment Status : Recruiting
First Posted : May 28, 2019
Last Update Posted : February 26, 2020
Sponsor:
Information provided by (Responsible Party):
TenNor Therapeutics Limited

Brief Summary:
The purpose of this study is to evaluate safety, tolerability, pharmacokinetic characteristics and efficacy of TNP-2092 in adults with ABSSSI suspected or confirmed to be caused by gram-positive pathogens.

Condition or disease Intervention/treatment Phase
Skin and Subcutaneous Tissue Bacterial Infections Gram-Positive Bacterial Infections Drug: TNP-2092 Drug: Vancomycin Phase 2

Detailed Description:
This Phase 2, double-blind, randomized, multicenter, parallel, controlled study is conducted to evaluate safety, tolerability, pharmacokinetics and efficacy of TNP-2092, and vancomycin in adults with ABSSSI suspected or confirmed to be caused by gram-positive pathogens. The duration of the treatment period is a minimum of 7 days and a maximum of 14 days.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: TNP-2092 300 mg intravenous every 12 hours vancomycin 1 g intravenous every 12 hours
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 2, Double-Blind, Randomized, Multicenter, Parallel, Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TNP-2092 to Treat Acute Bacterial Skin and Skin Structure Infection in Adults
Actual Study Start Date : April 20, 2019
Actual Primary Completion Date : September 18, 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TNP-2092
TNP-2092 300 mg intravenous every 12 hours
Drug: TNP-2092
TNP-2092 100mg/vial

Active Comparator: Vancomycin
vancomycin 1 g intravenous every 12 hours
Drug: Vancomycin
Vancomycin 1g/vial




Primary Outcome Measures :
  1. Adverse Events as assessed by CTCAE v4.0 [ Time Frame: Day 1 to Day 40 ]
    1. Incidence, causality, and severity
    2. thrombotic events
    3. local infusion site reactions
    4. tolerability

  2. Physical examination-Weight [ Time Frame: Day 1 to Day 40 ]
    Weight in kg

  3. Physical examination-Hight [ Time Frame: Day 1 to Day 40 ]
    Hight in cm

  4. Physical examination- others [ Time Frame: Day 1 to Day 40 ]
    head, ears, eyes, nose, throat dentition, thyroid, chest(heart, lungs),abdomen, skin/soft tissues, neurological, extremities, back, neck, musculoskeletal, and lymph nodes

  5. Vital signs-Temperature [ Time Frame: Day 1 to Day 40 ]
    Oral Temperature in celsius

  6. Vital signs- pulse rate [ Time Frame: Day 1 to Day 40 ]
    pulse rate

  7. Vital signs- respiratory rate [ Time Frame: Day 1 to Day 40 ]
    respiratory rate

  8. Vital signs - blood pressure [ Time Frame: Day 1 to Day 40 ]
    blood pressure in mmHg

  9. Major serum chemistry findings - ALT [ Time Frame: Day 1 to Day 40 ]
    ALT in IU/L

  10. Major serum chemistry findings - AST [ Time Frame: Day 1 to Day 40 ]
    AST in IU/L

  11. Major serum chemistry findings - Billirubin [ Time Frame: Day 1 to Day 40 ]
    Billirubin in mg/dL

  12. Major hematology findings - WBC [ Time Frame: Day 1 to Day 40 ]
    WBC in K/uL

  13. Major hematology findings - RBC [ Time Frame: Day 1 to Day 40 ]
    RBC in K/uL

  14. Major hematology findings - Platelet [ Time Frame: Day 1 to Day 40 ]
    Platelet in K/uL

  15. Major coagulation findings - PT [ Time Frame: Day 1 to Day 40 ]
    PT (protime) in seconds

  16. Major coagulation findings - PTT [ Time Frame: Day 1 to Day 40 ]
    PTT (partial thromboplastin time) in seconds

  17. Major urinalysis findings -pH [ Time Frame: Day 1 to Day 40 ]
    pH value

  18. Major urinalysis findings - Glucose [ Time Frame: Day 1 to Day 40 ]
    Glucose in mg/dL

  19. Major urinalysis findings - Protein [ Time Frame: Day 1 to Day 40 ]
    Protein in mg/dL

  20. Heptoglobin [ Time Frame: Day 1 to Day 40 ]
    Heptoglobin in mg/dL

  21. ECG findings [ Time Frame: Day 1 to Day 40 ]
    Triplicate 12-lead ECG assessment


Secondary Outcome Measures :
  1. Primary PK parameters-Cmax [ Time Frame: The first dose (Day 1) and the last dose (Day 3-14) ]
    Peak Plasma Concentration

  2. Primary PK parameters-tmax [ Time Frame: The first dose (Day 1) and the last dose (Day 3-14) ]
    Time to maximum plasma concentration

  3. Primary PK parameters - AUC0-12 [ Time Frame: The first dose (Day 1) and the last dose (Day 3-14) ]
    AUC versus time from time 0 to 12 hours

  4. Programmatic clinical response [ Time Frame: EA (48-72 hour) and EOT (Day 7-14) ]
    Percent reduction in primary ABSSSI lesion size

  5. Microbiological response [ Time Frame: EA (48-72 hour) and EOT (Day 7-14) ]
    Bacteria identification

  6. Investigator's assessment [ Time Frame: EA (48-72 hour) and EOT (Day 7-14) ]
    Improvement, Failure or Indeterminate



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects may be included in the study if they meet all of the following inclusion criteria:

    • Males or females, 18 years of age or older;
    • ABSSSI suspected or confirmed to be caused by gram-positive pathogens, including:
    • Cellulitis/erysipelas;
    • Wound infection;
    • Major cutaneous abscess;
    • Lesion with a minimum surface area of 75 cm2;
    • Capable of giving signed informed consent.

Exclusion Criteria:

  • Subjects will be excluded from the study if any of the following exclusion criteria apply prior to randomization:

    • History or hypersensitivity or intolerability to any fluoroquinolone, rifamycin or glycopeptide classes;
    • ABSSSI suspected or confirmed to be caused by pathogens that are resistant to the glycopeptide class;
    • Prior administration of systemic antibacterial therapy within 96 hours before randomization;
    • ABSSSI with suspected or confirmed infection caused by gram-negative or anaerobic organisms;
    • ABSSSI with suspected or confirmed infection caused by fungal, mycobacterial, parasitic, or viral pathogens;
    • Evidence of significant hepatic, hematologic, or immunologic disease;
    • History or evidence of severe renal disease.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03964493


Contacts
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Contact: TenNor +86-512-86861990 info@tennorx.com

Locations
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United States, California
eStudy Site Recruiting
San Diego, California, United States, 92120
Contact: Overcash, MD         
Sponsors and Collaborators
TenNor Therapeutics Limited
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Responsible Party: TenNor Therapeutics Limited
ClinicalTrials.gov Identifier: NCT03964493    
Other Study ID Numbers: PJI001-02
First Posted: May 28, 2019    Key Record Dates
Last Update Posted: February 26, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by TenNor Therapeutics Limited:
TNP-2092
ABSSSI
Safety
PK
Efficacy
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Bacterial Infections
Gram-Positive Bacterial Infections
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents