Back to resultsTD-1792 in Gram-positive Complicated Skin and Skin Structure Infection
Primary Purpose
Staphylococcal Skin Infection
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
TD-1792
Vancomycin
Sponsored by
About this trial
This is an interventional treatment trial for Staphylococcal Skin Infection focused on measuring cSSSI, Staph, MRSA
Eligibility Criteria
Inclusion Criteria:
- major abscess requiring surgical incision and drainage,infected burn, deep/extensive cellulitis, infected ulcer, wound infections
- requires at least 7 days of intravenous antibiotic treatment
Exclusion Criteria:
- more than 24 hours of antibiotic therapy
- moderate or severe liver disease
- severely neutropenic
- baseline QTc > 500 msec, congenital long QT syndrome, uncompensated heart failure, uncorrected abnormal K+ or Mg++ blood levels or severe left ventricular hypertrophy
Sites / Locations
- Allan Churukian
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
TD-1792
Vancomycin
Arm Description
Outcomes
Primary Outcome Measures
Clinical response
Secondary Outcome Measures
Full Information
NCT ID
NCT00442832
First Posted
February 28, 2007
Last Updated
January 15, 2021
Sponsor
Theravance Biopharma
1. Study Identification
Unique Protocol Identification Number
NCT00442832
Brief Title
TD-1792 in Gram-positive Complicated Skin and Skin Structure Infection
Official Title
A Phase 2, Randomized, Double Blind, Study of Intravenous TD 1792 Versus Vancomycin for Treatment of Complicated Gram Positive Skin and Skin Structure Infections
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Theravance Biopharma
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether TD-1792 is safe and effective when used to treat complicated skin and skin structure infections caused by Gram-positive bacteria.
Detailed Description
TD-1792 is compared to vancomycin for the treatment of cSSSI.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Staphylococcal Skin Infection
Keywords
cSSSI, Staph, MRSA
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
203 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TD-1792
Arm Type
Experimental
Arm Title
Vancomycin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
TD-1792
Intervention Description
TD-1792 2 mg/kg/day IV
Intervention Type
Drug
Intervention Name(s)
Vancomycin
Intervention Description
Vancomycin 1 Gm IV q 12 hrs
Primary Outcome Measure Information:
Title
Clinical response
Time Frame
7 to 14 days after last antibiotic dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
major abscess requiring surgical incision and drainage,infected burn, deep/extensive cellulitis, infected ulcer, wound infections
requires at least 7 days of intravenous antibiotic treatment
Exclusion Criteria:
more than 24 hours of antibiotic therapy
moderate or severe liver disease
severely neutropenic
baseline QTc > 500 msec, congenital long QT syndrome, uncompensated heart failure, uncorrected abnormal K+ or Mg++ blood levels or severe left ventricular hypertrophy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Theravance Biopharma
Official's Role
Study Director
Facility Information:
Facility Name
Allan Churukian
City
National City
State/Province
California
ZIP/Postal Code
91950
Country
United States
12. IPD Sharing Statement
Learn more about this trial
TD-1792 in Gram-positive Complicated Skin and Skin Structure Infection
We'll reach out to this number within 24 hrs