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TD-1792 in Gram-positive Complicated Skin and Skin Structure Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00442832
Recruitment Status : Completed
First Posted : March 2, 2007
Last Update Posted : January 20, 2021
Information provided by (Responsible Party):
Theravance Biopharma

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.

Condition or disease Intervention/treatment Phase
Staphylococcal Skin Infection Drug: TD-1792 Drug: Vancomycin Phase 2

Detailed Description:
TD-1792 is compared to vancomycin for the treatment of cSSSI.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 203 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : December 2006
Actual Primary Completion Date : May 2007
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: TD-1792 Drug: TD-1792
TD-1792 2 mg/kg/day IV

Active Comparator: Vancomycin Drug: Vancomycin
Vancomycin 1 Gm IV q 12 hrs

Primary Outcome Measures :
  1. Clinical response [ Time Frame: 7 to 14 days after last antibiotic dose ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00442832

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United States, California
Allan Churukian
National City, California, United States, 91950
Sponsors and Collaborators
Theravance Biopharma
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Study Director: Medical Monitor Theravance Biopharma
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Responsible Party: Theravance Biopharma Identifier: NCT00442832    
Other Study ID Numbers: 0041
First Posted: March 2, 2007    Key Record Dates
Last Update Posted: January 20, 2021
Last Verified: January 2021
Keywords provided by Theravance Biopharma:
Additional relevant MeSH terms:
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Communicable Diseases
Skin Diseases, Infectious
Staphylococcal Skin Infections
Connective Tissue Diseases
Pathologic Processes
Skin Diseases
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Skin Diseases, Bacterial
Anti-Bacterial Agents
Anti-Infective Agents