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

Phase 2

Completed

• Conditions: Staphylococcal Skin Infection
• Interventions: Drug: TD-1792; Drug: Vancomycin

• Registration Number: NCT00442832
• Lead Sponsor: 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.

Detailed Description

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

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2007-02-28
• Study First Submitted QC: 2007-02-28
• Study First Posted: 2007-03-02
• Primary Completion: 2007-05
• Study Completion: 2007-05
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-15
• Last Update Posted: 2021-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 203

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TD-1792	TD-1792	-
Vancomycin	Vancomycin	-

Primary Outcome Measures

Name	Time	Method
Clinical response	7 to 14 days after last antibiotic dose

Trial Locations

Locations (1)

Allan Churukian; 🇺🇸 National City, California, United States