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

Theravance Biopharma

Status and phase: Completed; Phase 2

Conditions: Staphylococcal Skin Infection

Treatments: Drug: TD-1792; Drug: Vancomycin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00442832

0041

Details and patient eligibility

About

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.

Full description

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

Enrollment: 203 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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203 participants in 2 patient groups

TD-1792

Experimental group

Treatment:

Drug: TD-1792

Vancomycin

Active Comparator group

Treatment:

Drug: Vancomycin