NCT01519778

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 27, 2012

Completed
19 days until next milestone

Study Start

First participant enrolled

February 15, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 27, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 27, 2012

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

March 12, 2015

Completed
Last Updated

August 29, 2018

Status Verified

July 1, 2018

Enrollment Period

6 months

First QC Date

January 24, 2012

Results QC Date

February 27, 2015

Last Update Submit

July 31, 2018

Conditions

Major Cutaneous AbscessCellulitisErysipelas

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

TR-701 FA

EXPERIMENTAL
Drug: TR701 FA

Interventions

TR701 FADRUG

1 tablet 200 mg once daily

Also known as: Tedizolid
TR-701 FA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Trius Investigator Site #118

Anaheim, California, 92804, United States

Location

Trius Investigator Site #129

Buena Park, California, 90620, United States

Location

Trius Investigator Site 103

Chula Vista, California, 91911, United States

Location

Trius Investigator Site 105

La Mesa, California, 91942, United States

Location

Trius Investigator Site #106

Long Beach, California, 90813, United States

Location

Trius Investigator Site 104

Oceanside, California, 92056, United States

Location

Trius Investigator Site 101

Columbus, Georgia, 31904, United States

Location

Trius Investigator Site 102

Savannah, Georgia, 31406, United States

Location

Trius Investigator Site 128

Las Vegas, Nevada, 89109, United States

Location

Trius Investigator Site 115

Somers Point, New Jersey, 08244, United States

Location

Related 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. Epub 2016 Aug 13.

    PMID: 27530088RESULT

MeSH Terms

Conditions

CellulitisErysipelas

Interventions

tedizolid

Condition Hierarchy (Ancestors)

Skin Diseases, InfectiousInfectionsSuppurationConnective Tissue DiseasesSkin and Connective Tissue DiseasesInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsStreptococcal InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesSkin Diseases, BacterialSkin Diseases

Results Point of Contact

Title
Carisa De Anda, Phd, Vice President Clinical Research
Organization
Cubist Pharmaceuticals
carisa.deanda@cubist.com
8583522639

Study Officials

  • Philippe Prokocimer, MD

    Trius Therapeutics

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2012

First Posted

January 27, 2012

Study Start

February 15, 2012

Primary Completion

August 27, 2012

Study Completion

August 27, 2012

Last Updated

August 29, 2018

Results First Posted

March 12, 2015

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will share

https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

More information

Locations

US(10)