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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 : January 20, 2021
Sponsor:
Information provided by (Responsible Party):
Theravance Biopharma

Tracking Information
First Submitted Date  ICMJE February 28, 2007
First Posted Date  ICMJE March 2, 2007
Last Update Posted Date January 20, 2021
Study Start Date  ICMJE December 2006
Actual Primary Completion Date May 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 15, 2009)
Clinical response [ Time Frame: 7 to 14 days after last antibiotic dose ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 28, 2007)
Clinical response
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE TD-1792 in Gram-positive Complicated Skin and Skin Structure Infection
Official Title  ICMJE A Phase 2, Randomized, Double Blind, Study of Intravenous TD 1792 Versus Vancomycin for Treatment of Complicated Gram Positive Skin and Skin Structure Infections
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Staphylococcal Skin Infection
Intervention  ICMJE
  • Drug: TD-1792
    TD-1792 2 mg/kg/day IV
  • Drug: Vancomycin
    Vancomycin 1 Gm IV q 12 hrs
Study Arms  ICMJE
  • Experimental: TD-1792
    Intervention: Drug: TD-1792
  • Active Comparator: Vancomycin
    Intervention: Drug: Vancomycin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 15, 2009)
203
Original Enrollment  ICMJE
 (submitted: February 28, 2007)
200
Actual Study Completion Date  ICMJE May 2007
Actual Primary Completion Date May 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00442832
Other Study ID Numbers  ICMJE 0041
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Theravance Biopharma
Study Sponsor  ICMJE Theravance Biopharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Theravance Biopharma
PRS Account Theravance Biopharma
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP