NCT00442832

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
203

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 2, 2007

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

January 20, 2021

Status Verified

January 1, 2021

Enrollment Period

5 months

First QC Date

February 28, 2007

Last Update Submit

January 15, 2021

Conditions

Staphylococcal Skin Infection

Keywords

cSSSIStaphMRSA

Outcome Measures

Primary Outcomes (1)

  • Clinical response

    7 to 14 days after last antibiotic dose

Study Arms (2)

TD-1792

EXPERIMENTAL
Drug: TD-1792

Vancomycin

ACTIVE COMPARATOR
Drug: Vancomycin

Interventions

TD-1792DRUG

TD-1792 2 mg/kg/day IV

TD-1792
VancomycinDRUG

Vancomycin 1 Gm IV q 12 hrs

Vancomycin

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Allan Churukian

National City, California, 91950, United States

Location

MeSH Terms

Conditions

Staphylococcal Skin InfectionsStaphylococcal Infections

Interventions

cefilavancinVancomycin

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsSkin Diseases, BacterialSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

GlycopeptidesGlycoconjugatesCarbohydratesPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Medical Monitor

    Theravance Biopharma

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2007

First Posted

March 2, 2007

Study Start

December 1, 2006

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

January 20, 2021

Record last verified: 2021-01

Locations

US(1)