Cellulitis, Erysipelas, Major Cutaneous Abscess
Conditions
Brief summary
Characterization of the safety profile of TR-701 Free Acid (FA) in patients with major cutaneous abscess or cellulitis/erysipelas.
Detailed description
This is an open-label, multicenter study of oral TR-701 FA 200 mg once daily for 6 days for the treatment of major cutaneous abscess or cellulitis/erysipelas in patients 18 years of age or older. This study is designed to further characterize the safety profile and gather additional lesion measurement data of TR-701 FA in patients with major cutaneous abscess or cellulitis/erysipelas.
Interventions
DRUGTR701 FA
1 tablet 200 mg once daily
Sponsors
Bayer
Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) | 24-31 days | Safety will be assessed through summaries of the incidence of AEs and SAEs as well as through summaries of vital signs, physical examinations, ECG findings, and laboratory assessments (hematology, serum chemistry, and urinalysis). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TR-701 FA TR701 FA: 1 tablet 200 mg once daily | 200 |
| Total | 200 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 10 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | TR-701 FA |
|---|---|
| Age, Continuous | 39.5 years STANDARD_DEVIATION 13.04 |
| Sex: Female, Male Female | 71 Participants |
| Sex: Female, Male Male | 129 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 58 / 200 |
| serious Total, serious adverse events | 2 / 200 |
Outcome results
Primary
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Safety will be assessed through summaries of the incidence of AEs and SAEs as well as through summaries of vital signs, physical examinations, ECG findings, and laboratory assessments (hematology, serum chemistry, and urinalysis).
Time frame: 24-31 days
Population: Patients receiving any amount of study drug
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TR-701 FA | Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) | 91 participants |