Status:
COMPLETED
TD-1792 in Gram-positive Complicated Skin and Skin Structure Infection
Lead Sponsor:
Theravance Biopharma
Conditions:
Staphylococcal Skin Infection
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
203 Patients enrolled
Trial Details
Trial ID
NCT00442832
Start Date
December 1 2006
End Date
May 1 2007
Last Update
January 20 2021
Active Locations (1)
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1
Allan Churukian
National City, California, United States, 91950