Phase 2
N=200
A Phase 2 Safety and Exploratory Skin Lesion Measurement of TR-701 FA Study
Major Cutaneous Abscess · Cellulitis · Erysipelas
Bottom Line
View on ClinicalTrials.gov: NCT01519778 ↗Enrolled (actual)
200
Serious AEs
1.0%
Results posted
Mar 2015
Primary outcome: Primary: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) — 91 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- TR701 FA (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Primary completion
- Aug 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) |
91 | — |
Summary
Characterization of the safety profile of TR-701 Free Acid (FA) in patients with major cutaneous abscess or cellulitis/erysipelas.
Eligibility Criteria
Inclusion Criteria
- Male or female patients ≥ 18 years of age
- Suspected or documented gram-positive infection from baseline Gram stain or culture.
- Cellulitis/erysipelas or major cutaneous abscesses at Screening
Exclusion Criteria
- Postsurgical or open wound infections
- Severe sepsis or septic shock
- Uncomplicated skin and skin structure infections such as furuncles, minor abscesses (< 75 cm2 or area of suppuration not surrounded by cellulitis/erythema), and impetiginous lesions
- Infections associated with, or in close proximity to, a prosthetic device
- Known bacteremia or osteomyelitis at time of screening
Data sourced from ClinicalTrials.gov (NCT01519778). 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.