Phase 2 Trial of TD 6424 (Telavancin) Versus Standard Therapy for Complicated Gram Positive Skin and Skin Structure Infections (Gram Positive cSSSI)

Study Overview
=================
Brief Summary
-----------------
Serious infections caused by resistant bacteria are becoming more of a medical problem throughout the world. One of the ways to deal with this problem is to develop new drugs that can control these bacteria. This study will measure how well TD-6424 (Telavancin) can control infections and whether this drug can be safely given to patients.

Official Title
-----------------
A Phase 2, Randomized, Double-Blind, Multinational Trial of Intravenous Telavancin Versus Standard Therapy for Treatment of Complicated Gram Positive Skin and Skin Structure Infections (Gram Positive cSSSI)

Conditions
-----------------
Infections, Gram-Positive Bacterial, Abscess, Burns, Cellulitis, Ulcer, Wound Infections

Intervention / Treatment
-----------------
* Drug: Telavancin
* Drug: Vancomycin or antistaphylococcal penicillin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have a diagnosis of one of the following complicated skin and skin structure infections with either a suspected or confirmed Gram positive organism as the major cause of the infection: major abscess requiring surgical incision and drainage infected burn (see exclusion criteria for important qualifications) deep/extensive cellulitis infected ulcer (see exclusion criteria for important qualifications) wound infections Patients must be expected to require at least 4 days of intravenous antibiotic treatment Exclusion Criteria: Previous systemic antibacterial therapy (with the exception of aztreonam and metronidazole) for > 24 hours within 7 days prior to the first dose of study medication unless the pathogen was resistant to prior treatment or the patient was a treatment failure (no clinical improvement after 3 days). Burns involving > 20% of body surface area or third degree/full thickness in nature, diabetic foot ulcers, ischemic ulcers/wounds, necrotizing fasciitis, gas gangrene, or mediastinitis.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telavancin<br> | Drug: Telavancin<br>* Telavancin 7.5 mg/kg/day IV (intravenously) for up to 14 days<br>* Other names: TD-6424;|
| Active Comparator: Standard of care for cSSSI<br>cSSSI - complicated skin and skin structure infections | Drug: Vancomycin or antistaphylococcal penicillin<br>* Vancomycin 1 Gram IV (intravenously) every 12 hrs or nafcillin 2 Grams, oxacillin 2 Grams, or (in South Africa) cloxacillin 0.5 - 1 Gram, IV (intravenously) every 6 hrs for up to 14 days.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Response Which is Measured at Test of Cure (TOC) in the Clinically Evaluable (CE) Population | Cure: Resolution of clinically significant signs, symptoms associated with the skin infection present at study admission or improvement to the extent that the infectious process had been controlled and no further therapy with study medication was necessary. Failure: Inadequate response to study therapy or the need for significant surgical management (e.g. more than just routine debridement) of the infection site following antibiotic therapy and prior to the Test-of-Cure (TOC) visit. Indeterminate: Inability to determine outcome. | 7-14 days following end of antibiotic treatment |