Phase 2 Completed N=200 Other

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

Major Cutaneous Abscess · Cellulitis · Erysipelas

Source: ClinicalTrials.gov NCT01519778 ↗

Enrolled (actual)

200

Serious AEs

1.0%

Results posted

Mar 2015

Primary outcomePrimary: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) — 91 participants

Summary

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

Outcome Measures

Outcome	Result	p-value
PRIMARY Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)	91	—

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

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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. Informational only — not medical advice.