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Completed

NCT Number: NCT00442832

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

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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Key information

Conditions

Staphylococcal Skin Infection Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Skin Diseases Skin Diseases, Bacterial Skin Diseases, Infectious Skin and Connective Tissue Diseases Staphylococcal Infections Staphylococcal Skin Infections

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Allan Churukian

National City, California, 91950, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TD-1792

Drug

TD-1792 2 mg/kg/day IV

Vancomycin

Drug

Vancomycin 1 Gm IV q 12 hrs

Primary outcomes

  1. Clinical response

    Time frame: 7 to 14 days after last antibiotic dose

Sponsors and collaborators

Lead sponsor

Theravance Biopharma

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Mar 2, 2007
Registry last updated
Jan 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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