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

Completed · Phase 2

Conditions studied: Major Cutaneous Abscess, Cellulitis, Erysipelas

In brief

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

Key facts

Study ID

NCT01519778

Run by

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

People needed

200

Starts

2012-02-15

Expected to finish

2012-08-27

Last updated by the study team

2018-08-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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 105 — La Mesa, California, United States
• Trius Investigator Site #106 — Long Beach, California, United States
• Trius Investigator Site 104 — Oceanside, California, United States
• Trius Investigator Site 101 — Columbus, Georgia, United States
• Trius Investigator Site 102 — Savannah, Georgia, United States
• Trius Investigator Site 128 — Las Vegas, Nevada, United States
• Trius Investigator Site 115 — Somers Point, New Jersey, United States

Full record on ClinicalTrials.gov

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