Phase 2
Completed N=120
TNP-2092 to Treat Acute Bacterial Skin and Skin Structure Infection
Skin and Subcutaneous Tissue Bacterial Infections · Gram-Positive Bacterial Infections
Source: ClinicalTrials.gov NCT03964493 ↗
Enrolled (actual)
120
Serious AEs
2.6%
Results posted
Dec 2023
Primary outcomePrimary: Early Clinical Response at the Early Assessment (EA) Visit in the Intent-to-Treat (ITT) Population — 61; 27; 4; 3 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Early Clinical Response at the Early Assessment (EA) Visit in the Intent-to-Treat (ITT) Population |
61; 27; 4; 3; 15; 10 | — |
| PRIMARY Early Clinical Response at the Early Assessment Visit in the Modified Intent-to-Treat (mITT) Population |
60; 27; 4; 3; 14; 10 | — |
| PRIMARY Early Clinical Response at the Early Assessment Visit in the Micro-Intent-to-Treat (Micro-ITT) Population |
41; 19; 3; 2; 7; 8 | — |
| SECONDARY Investigator Assessment of Clinical Response at Post Treatment Evaluation (PTE) Visit in the mITT Population |
62; 31; 2; 3; 14; 6 | — |
| SECONDARY Investigator Assessment of Clinical Response at Post Treatment Evaluation (PTE) Visit in the Micro-ITT Population |
40; 23; 2; 1; 9; 5 | — |
| SECONDARY Investigator's Assessment of Clinical Response at the End of Treatment (EOT) Visit in the mITT Population |
68; 31; 2; 3; 8; 6 | — |
| SECONDARY Investigator's Assessment of Clinical Response at the End of Treatment (EOT) Visit in the Micro-ITT Population |
45; 23; 2; 1; 4; 5 | — |
| SECONDARY AUC0-12h After First Infusion |
135000 | — |
| SECONDARY AUC0-12h After Last Infusion |
159000 | — |
| SECONDARY Cmax After Last Infusion |
38500 | — |
| SECONDARY Cmax After First Infusion |
37500 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT03964493). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.