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

A Phase 2, Randomized, Double Blind, Study of Intravenous TD 1792 Versus Vancomycin for Treatment of Complicated Gram Positive Skin and Skin Structure Infections

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00442832

Enrollment

203

Registered

2007-03-02

Start date

2006-12-31

Completion date

2007-05-31

Last updated

2021-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Staphylococcal Skin Infection

Keywords

cSSSI, Staph, MRSA

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.

Interventions

DRUGTD-1792

TD-1792 2 mg/kg/day IV

DRUGVancomycin

Vancomycin 1 Gm IV q 12 hrs

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
Clinical response	7 to 14 days after last antibiotic dose

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026