TNP-2092 to Treat Acute Bacterial Skin and Skin Structure Infection (NCT03964493) | Clinical Trial Compass
CompletedPhase 2
TNP-2092 to Treat Acute Bacterial Skin and Skin Structure Infection
United States120 participantsStarted 2019-04-20
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Early Clinical Response at the Early Assessment (EA) Visit in the Intent-to-Treat (ITT) Population
Timeframe: 48 to 72 hours after the first dose of study treatment
2
Early Clinical Response at the Early Assessment Visit in the Modified Intent-to-Treat (mITT) Population
Timeframe: 48 to 72 hours after the first dose of study treatment
3
Early Clinical Response at the Early Assessment Visit in the Micro-Intent-to-Treat (Micro-ITT) Population
Timeframe: 48 to 72 hours after the first dose of study treatment