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

• ClinicalTrials.gov Identifier: NCT00442832
• Recruitment Status: Completed
• First Posted: March 2, 2007
• Last Update Posted: January 20, 2021
• Sponsor: Theravance Biopharma
• Information provided by (Responsible Party): Theravance Biopharma

Tracking Information

• First Submitted Date: February 28, 2007
• First Posted Date: March 2, 2007
• Last Update Posted Date: January 20, 2021
• Study Start Date: December 2006
• Actual Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: August 15, 2009): Clinical response [ Time Frame: 7 to 14 days after last antibiotic dose ]
• Original Primary Outcome Measures (submitted: February 28, 2007): Clinical response
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Staphylococcal Skin Infection

Intervention

• Drug: TD-1792
  TD-1792 2 mg/kg/day IV
• Drug: Vancomycin
  Vancomycin 1 Gm IV q 12 hrs

Study Arms

• Experimental: TD-1792
  Intervention: Drug: TD-1792
• Active Comparator: Vancomycin
  Intervention: Drug: Vancomycin

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 15, 2009): 203
• Original Enrollment (submitted: February 28, 2007): 200
• Actual Study Completion Date: May 2007
• Actual Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00442832
• Other Study ID Numbers: 0041
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Theravance Biopharma
• Study Sponsor: Theravance Biopharma
• Collaborators: Not Provided

Investigators

• Study Director: Medical Monitor; Theravance Biopharma

• PRS Account: Theravance Biopharma
• Verification Date: January 2021