Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03964493
Other study ID # PJI001-02
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date April 20, 2019
Est. completion date September 28, 2020

Study information

Verified date November 2023
Source TenNor Therapeutics Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date September 28, 2020
Est. primary completion date September 28, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
TNP-2092
TNP-2092 100mg/vial
Vancomycin
Vancomycin 1g/vial

Locations

Country Name City State
United States eStudy Site San Diego California

Sponsors (1)

Lead Sponsor Collaborator
TenNor Therapeutics Limited

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Early Clinical Response at the Early Assessment (EA) Visit in the Intent-to-Treat (ITT) Population Early clinical response is defined as responder meeting two criteria: (1) patient had at least a 20% reduction of acute bacterial skin and skin structure infection (ABSSSI) primary lesion size compared to baseline measurements; (2) patient did not die of any cause within 72 hours of the first dose of study treatment. An indeterminate classification is used for a response that could not be adequately inferred because study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up, did not attend the EA clinic appointment), or if the early assessment visit is out of the 48 to 72 hours window after the intravenous study treatment starts. 48 to 72 hours after the first dose of study treatment
Primary Early Clinical Response at the Early Assessment Visit in the Modified Intent-to-Treat (mITT) Population Early clinical response is defined as responder meeting two criteria: (1) patient had at least a 20% reduction of acute bacterial skin and skin structure infection (ABSSSI) primary lesion size compared to baseline measurements; (2) patient did not die of any cause within 72 hours of the first dose of study treatment. An indeterminate classification is used for a response that could not be adequately inferred because study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up, did not attend the EA clinic appointment), or if the early assessment visit is out of the 48 to 72 hours window after the intravenous study treatment starts. 48 to 72 hours after the first dose of study treatment
Primary Early Clinical Response at the Early Assessment Visit in the Micro-Intent-to-Treat (Micro-ITT) Population Early clinical response is defined as responder meeting two criteria: (1) patient had at least a 20% reduction of acute bacterial skin and skin structure infection (ABSSSI) primary lesion size compared to baseline measurements; (2) patient did not die of any cause within 72 hours of the first dose of study treatment. An indeterminate classification is used for a response that could not be adequately inferred because study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up, did not attend the EA clinic appointment), or if the early assessment visit is out of the 48 to 72 hours window after the intravenous study treatment starts. 48 to 72 hours after the first dose of study treatment
Secondary Investigator Assessment of Clinical Response at Post Treatment Evaluation (PTE) Visit in the mITT Population At the PTE Visit the investigator indicated one of the following outcomes relating to the primary infection under study: Clinical Success: participant was alive; the ABSSSI sufficiently resolved such that further antibacterial therapy is not needed. Clinical Failure: any of the following: (1)Investigator discontinued study treatment and indicated that the ABSSSI had responded inadequately such that alternative (rescue) non-study antibacterial therapy was needed; (2)participant received antibacterial therapy for a different infection that may be effective for the ABSSSI under study; (3) participant developed an adverse event (AE) that required discontinuation of study treatment before completion of the planned treatment regimen; (4) unplanned major surgical treatment for the ABSSSI under study; (5) participant died of any cause up to the specified visit. Indeterminate: study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up). 7 to 14 days after the end of study treatment
Secondary Investigator Assessment of Clinical Response at Post Treatment Evaluation (PTE) Visit in the Micro-ITT Population At the PTE Visit the investigator indicated one of the following outcomes relating to the primary infection under study: Clinical Success: participant was alive; the ABSSSI sufficiently resolved such that further antibacterial therapy is not needed. Clinical Failure: any of the following: (1)Investigator discontinued study treatment and indicated that the ABSSSI had responded inadequately such that alternative (rescue) non-study antibacterial therapy was needed; (2)participant received antibacterial therapy for a different infection that may be effective for the ABSSSI under study; (3) participant developed an adverse event (AE) that required discontinuation of study treatment before completion of the planned treatment regimen; (4) unplanned major surgical treatment for the ABSSSI under study; (5) participant died of any cause up to the specified visit. Indeterminate: study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up). 7 to 14 days after the end of study treatment
Secondary Investigator's Assessment of Clinical Response at the End of Treatment (EOT) Visit in the mITT Population At the EOT Visit the investigator indicated one of the following outcomes relating to the primary infection under study: Clinical Success: participant was alive; the ABSSSI sufficiently resolved such that further antibacterial therapy is not needed. Clinical Failure: any of the following: (1)Investigator discontinued study treatment and indicated that the ABSSSI had responded inadequately such that alternative (rescue) non-study antibacterial therapy was needed; (2)participant received antibacterial therapy for a different infection that may be effective for the ABSSSI under study; (3) participant developed an adverse event (AE) that required discontinuation of study treatment before completion of the planned treatment regimen; (4) unplanned major surgical treatment for the ABSSSI under study; (5) participant died of any cause up to the specified visit. Indeterminate: study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up). After a minimum of 7 days up to 14 days of study treatment
Secondary Investigator's Assessment of Clinical Response at the End of Treatment (EOT) Visit in the Micro-ITT Population At the EOT Visit the investigator indicated one of the following outcomes relating to the primary infection under study: Clinical Success: participant was alive; the ABSSSI sufficiently resolved such that further antibacterial therapy is not needed. Clinical Failure: any of the following: (1)Investigator discontinued study treatment and indicated that the ABSSSI had responded inadequately such that alternative (rescue) non-study antibacterial therapy was needed; (2)participant received antibacterial therapy for a different infection that may be effective for the ABSSSI under study; (3) participant developed an adverse event (AE) that required discontinuation of study treatment before completion of the planned treatment regimen; (4) unplanned major surgical treatment for the ABSSSI under study; (5) participant died of any cause up to the specified visit. Indeterminate: study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up). After a minimum of 7 days up to 14 days of study treatment
Secondary AUC0-12h After First Infusion Partial area under the concentration versus time curve from time zero to time 12 hours. 0 to 12 hours post-dose
Secondary AUC0-12h After Last Infusion Partial area under the concentration versus time curve from time zero to time 12 hours 0 to 12 hours post-dose
Secondary Cmax After Last Infusion Maximum observed concentration 57 to 60 minutes, 1.5 to 3 hours, 4 to 6 hours, 12 hours, after the last infusion
Secondary Cmax After First Infusion Maximum observed concentration 57 to 60 minutes, 1.5 to 3 hours, 4 to 6 hours, 12 hours, after the first infusion
See also
  Status Clinical Trial Phase
Completed NCT01412801 - Magnitude of the Antibody Response to and Safety of a GBS Trivalent Vaccine in HIV Positive and HIV Negative Pregnant Women and Their Offsprings Phase 2
Terminated NCT00108433 - Linezolid in the Treatment of Hemodialysis Patients With Catheter-Related Gram-Positive Bloodstream Infections Phase 3
Completed NCT00501150 - Oral Antibiotic Treatment at Home Instead of Intravenous Treatment in Hospital for Resistant Gram Positive Infections N/A
Not yet recruiting NCT06444802 - Model-informed Precision Dosing for Linezolid Phase 3
Terminated NCT00529282 - A Study of Ceftobiprole in Patients With Fever and Neutropenia. Phase 3
Completed NCT00079976 - Study Evaluating Tigecycline in Selected Serious Infections Caused by Vancomycin-Resistant Enterococcus (VRE) or Methicillin-Resistant Staphylococcus Aureus (MRSA) Phase 3
Terminated NCT00835783 - Validation Study of Combined Positron Emission Tomography/Computer Tomography to Diagnose Infection and Inflammation N/A
Completed NCT00081744 - Study Comparing Tigecycline to Imipenem/Cilastatin in Complicated Intra-Abdominal Infections in Hospitalized Subjects Phase 3
Completed NCT03747497 - Contezolid Acefosamil Versus Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infection Phase 2
Active, not recruiting NCT04911270 - Clinical Decision Support Tool for Vancomycin Dosing in Children N/A
Completed NCT02750761 - A Study of Oral and Intravenous (IV) Tedizolid Phosphate in Hospitalized Participants, Ages 2 to <12 Years, With Confirmed or Suspected Bacterial Infection (MK-1986-013) Phase 1
Completed NCT00406198 - Impact of Continuous Venovenous Haemofiltration on Organ Failure During the Early Phase of Severe Sepsis Phase 4
Completed NCT03560440 - Evaluation of the Dosing Regimen of Vancomycin in Pediatric Patients
Completed NCT00147511 - Time To Efficacy and Onset Of Action Of Linezolid Phase 4
Terminated NCT00240747 - Open-label, Multiple-dose, Phase III Study of the Population Pharmacokinetics of I.V. Synercid in 75 Pediatric Patients Phase 3
Not yet recruiting NCT04917380 - The Clinical Character,Risk and Prognosis of Post-neurosurgical Intracranial Infection With Different Pathogens.
Completed NCT00736554 - What is the Prevalence of Methicillin-Resistant Staphylococcus Aureus in Skin and Soft Tissue Infections Presenting to the Emergency Departments of a Canadian Academic Health Care Center? N/A
Completed NCT03361163 - Controlled Human Infection for Vaccination Against Streptococcus Pyogenes Phase 1
Completed NCT00167960 - Study Evaluating Vancomycin-Resistant Enterococci in a Hematology Unit Phase 4
Completed NCT00874367 - Early-Onset Sepsis Surveillance Study N/A