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

January 15, 2021 updated by: Theravance Biopharma

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

203

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • National City, California, United States, 91950
        • Allan Churukian

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Vancomycin
Drug: Vancomycin
Vancomycin 1 Gm IV q 12 hrs
EXPERIMENTAL: TD-1792
Drug: TD-1792
TD-1792 2 mg/kg/day IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical response
Time Frame: 7 to 14 days after last antibiotic dose
7 to 14 days after last antibiotic dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Theravance Biopharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (ACTUAL)

May 1, 2007

Study Completion (ACTUAL)

May 1, 2007

Study Registration Dates

First Submitted

February 28, 2007

First Submitted That Met QC Criteria

February 28, 2007

First Posted (ESTIMATE)

March 2, 2007

Study Record Updates

Last Update Posted (ACTUAL)

January 20, 2021

Last Update Submitted That Met QC Criteria

January 15, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0041

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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