CompletedPhase 2

Phase 2 Study of TR-701 in Patients With Complicated Skin and Skin Structure Infections

United States192 participantsStarted 2008-09-17

Plain-language summary

The purpose of the study is to determine the oral dosage of TR-701 to be used in Phase III studies in patients with complicated skin and skin structure infections.

Who can participate

Age range

18 Years – 75 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: * Diagnosed with complicated skin and skin structure infection with at least 2 signs and symptoms * Suspected or confirmed infection due to a gram-positive organism Exclusion Criteria: * Complicated skin and skin structure infection due to gram-negative organisms * Complicated skin and skin structure infections requiring more than 7 days of therapy * Uncontrolled diabetes * Chronic systemic immunosuppressive therapy * AIDS with CD4 count \< 200 cells/mm3 * Uncontrolled hypertension * Mild moderate or severe renal failure * Severe hepatic disease * Neutropenia * Use of antidepressants such as SSRIs or MAOIs for 14 days before first dose of study drug * Women who are pregnant or nursing

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

Clinical Response Rate at Test of Cure in the Clinically Evaluable Analysis Set

Timeframe: 7 to 14 days after the last dose of study drug

Clinical Response Rate at Test of Cure in the Clinical Modified Intent to Treat Analysis Set

Timeframe: 7-14 days after last dose of study drug

Trial details

NCT IDNCT00761215

SponsorTrius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-02-24

Results submitted2014-07-15

View on ClinicalTrials.gov More Skin Diseases, Infectious trials

Who can participate

Age range

18 Years – 75 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.