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

Sponsor

Theravance Biopharma (Industry)

Overall Status

Completed

CT.gov ID

NCT00442832

Collaborator

(none)

203

Enrollment

Location

Arms

Duration (Months)

40.9

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

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 :

Dec 1, 2006

Actual Primary Completion Date :

May 1, 2007

Actual Study Completion Date :

May 1, 2007

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Clinical response [7 to 14 days after last antibiotic dose]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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