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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

203 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2007-05-31

Brief Summary

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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.

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Detailed Description

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

Conditions

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Staphylococcal Skin Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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TD-1792

Group Type EXPERIMENTAL

TD-1792

Intervention Type DRUG

TD-1792 2 mg/kg/day IV

Vancomycin

Group Type ACTIVE_COMPARATOR

Vancomycin

Intervention Type DRUG

Vancomycin 1 Gm IV q 12 hrs

Interventions

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TD-1792

TD-1792 2 mg/kg/day IV

Intervention Type DRUG

Vancomycin

Vancomycin 1 Gm IV q 12 hrs

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No