A Phase 2 Safety and Exploratory Skin Lesion Measurement of TR-701 FA Study

Cellulitis Clinical Trial

Official title:

Phase 2 Open-Label Safety and Exploratory Skin Lesion Measurement Study of 6-Day Oral TR-701 FA in Skin Abscess and Cellulitis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01519778
• Other study ID #: 1986-011
• Secondary ID: TR701-126
• Status: Completed
• Phase: Phase 2
• Start date: February 15, 2012
• Est. completion date: August 27, 2012

Study information

• Verified date: July 2018
• Source: Trius Therapeutics LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Characterization of the safety profile of TR-701 Free Acid (FA) in patients with major cutaneous abscess or cellulitis/erysipelas.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: August 27, 2012
• Est. primary completion date: August 27, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abscess
• Cellulitis
• Erysipelas
• Major Cutaneous Abscess

Intervention

Drug:
• TR701 FA
1 tablet 200 mg once daily

Locations

Country	Name	City	State
United States	Trius Investigator Site #118	Anaheim	California
United States	Trius Investigator Site #129	Buena Park	California
United States	Trius Investigator Site 103	Chula Vista	California
United States	Trius Investigator Site 101	Columbus	Georgia
United States	Trius Investigator Site 105	La Mesa	California
United States	Trius Investigator Site 128	Las Vegas	Nevada
United States	Trius Investigator Site #106	Long Beach	California
United States	Trius Investigator Site 104	Oceanside	California
United States	Trius Investigator Site 102	Savannah	Georgia
United States	Trius Investigator Site 115	Somers Point	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Trius Therapeutics LLC	Bayer

Country where clinical trial is conducted

United States, 

References & Publications (1)

Powers JH 3rd, Das AF, De Anda C, Prokocimer P. Clinician-reported lesion measurements in skin infection trials: Definitions, reliability, and association with patient-reported pain. Contemp Clin Trials. 2016 Sep;50:265-72. doi: 10.1016/j.cct.2016.08.010. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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).	24-31 days