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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.
 
ClinicalTrials.gov Identifier: NCT00442832
Recruitment Status : Completed
First Posted : March 2, 2007
Last Update Posted : September 11, 2018
Sponsor:
Information provided by:
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

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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
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

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 ClinicalTrials.gov identifier (NCT number): NCT00442832


Locations
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United States, California
Allan Churukian
National City, California, United States, 91950
Sponsors and Collaborators
Theravance Biopharma
Investigators
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Study Director: Steven L Barriere, PharmD Theravance Biopharma
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Responsible Party: Steven Barriere, Pharm.D., Vice President, Clinical and Medical Affairs, Theravance, Inc.
ClinicalTrials.gov Identifier: NCT00442832    
Other Study ID Numbers: 0041
First Posted: March 2, 2007    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018
Keywords provided by Theravance Biopharma:
cSSSI
Staph
MRSA
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Cellulitis
Skin Diseases, Infectious
Staphylococcal Skin Infections
Suppuration
Connective Tissue Diseases
Inflammation
Pathologic Processes
Skin Diseases
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Skin Diseases, Bacterial
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents