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

Staphylococcal Skin Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00442832
• Other study ID #: 0041
• Status: Completed
• Phase: Phase 2
• Start date: December 2006
• Est. completion date: May 2007

Study information

• Verified date: January 2021
• Source: Theravance Biopharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cellulitis
• Communicable Diseases
• Infection
• Skin Diseases, Infectious
• Staphylococcal Skin Infection
• Staphylococcal Skin Infections

Intervention

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

Locations

Country	Name	City	State
United States	Allan Churukian	National City	California

Sponsors (1)

Lead Sponsor	Collaborator
Theravance Biopharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical response		7 to 14 days after last antibiotic dose