ClinicalTrials.gg
CompletedNCT00442832Updated Jan 20, 2021

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

A Phase 2 interventional study of TD-1792 and Vancomycin in Staphylococcal Skin Infection, sponsored by Theravance Biopharma. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-01-20.

Sponsored by Theravance Biopharma (part of Zymeworks) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
203
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the detailed description

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

02

Conditions studied

  • Staphylococcal Skin Infection

Keywords

  • cSSSI
  • Staph
  • MRSA
03

In context

Staphylococcal Skin Infections

30 studies on the registry are indexed under Staphylococcal Skin Infections; none are open to participants now.

This study's enrollment of 203 is below the median of 227 across 28 interventional studies indexed under Staphylococcal Skin Infections.

Browse Staphylococcal Skin Infections studies →

Lead sponsor

Theravance Biopharma is the lead sponsor of 47 studies on the registry; none are open to participants now.

Of its 24 completed or terminated interventional studies of FDA-regulated products, 11 (46%) have results posted.

First submitted before Theravance Biopharma became part of Zymeworks.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • more than 24 hours of antibiotic therapy
  • moderate or severe liver disease
  • severely neutropenic
  • baseline > 500 msec, congenital long QT syndrome, uncompensated heart failure, uncorrected abnormal K+ or Mg++ blood levels or severe left ventricular hypertrophy
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
203 participants (actual)

Study arms

  • Experimental
    TD-1792

    Drug: TD-1792

  • Active comparator
    Vancomycin

    Drug: Vancomycin

Interventions

  • DrugTD-1792

    TD-1792 2 mg/kg/day IV

  • Vancomycin 1 Gm IV q 12 hrs

06

What researchers measure

Primary outcomes

  1. Clinical response

    Time frame: 7 to 14 days after last antibiotic dose

07

Study locations

1 site
  • Allan Churukian
    National City, California 91950, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 20, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00442832
Responsible party
Sponsor
First posted
Mar 2, 2007
Start date
Dec 2006
Primary completion
May 2007
Completion
May 2007
Last update
Jan 20, 2021

Study contacts

Medical Monitor
study director · Theravance Biopharma

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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