NCT00107978

Brief Summary

Study 0018 (NCT00107978) compares the safety and effectiveness of an investigational drug, telavancin, and an approved drug, vancomycin, for the treatment of complicated skin and skin structure infections.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,035

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Feb 2005

Shorter than P25 for phase_3

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

February 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 12, 2005

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
3.8 years until next milestone

Results Posted

Study results publicly available

February 1, 2010

Completed
Last Updated

January 16, 2019

Status Verified

January 1, 2019

Enrollment Period

1.2 years

First QC Date

April 11, 2005

Results QC Date

November 3, 2009

Last Update Submit

January 14, 2019

Conditions

Staphylococcal Skin Infection

Keywords

cSSSI (complicated Skin and Skin Structure Infections)Staph (Staphylococcus)MRSA (Methicillin-resistant Staphylococcus Aureus)

Outcome Measures

Primary Outcomes (1)

  • Clinical Response

    The Clinical Response for each patient was determined by the investigator by assessing the patient's clinical signs \& symptoms compared with the Baseline evaluation. Cure: resolution of signs and symptoms associated with the skin infection present at study admission such that no further antibiotic therapy was necessary; Not Cured: inadequate response to study therapy; Indeterminate: unable to determine outcome.

    7 to 14 days after the last antibiotic dose

Study Arms (2)

Telavancin

EXPERIMENTAL
Drug: Telavancin

Vancomycin

ACTIVE COMPARATOR
Drug: Vancomycin

Interventions

TelavancinDRUG

Telavancin 10 mg/kg/day, IV for up to 14 days.

Also known as: VIBATIV, TD-6424
Telavancin
VancomycinDRUG

Vancomycin 1 Gm IV administered every 12 hrs for up to 14 days.

Vancomycin

Eligibility Criteria

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

You may qualify if:

  • Patients must have a diagnosis of one of the following complicated skin and skin structure infections with MRSA (Methicillin-resistant Staphylococcus Aureus) either suspected or confirmed as the major cause of the infection:
  • major abscess requiring surgical incision and drainage;

You may not qualify if:

  • deep/extensive cellulitis;
  • wound infections
  • Patients must be expected to require at least 7 days of intravenous antibiotic treatment.
  • Received more than 24 hours of potentially effective systemic (IV/IM or PO) antibiotic therapy
  • Burns involving \> 20% of body surface area or third degree/full thickness in nature, diabetic foot ulcers, ischemic ulcers/wounds, necrotizing fasciitis, gas gangrene, or mediastinitis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Louisiana State University Health Sciences Center, Dept of Med/ER Med

New Orleans, Louisiana, 70112, United States

Location

Related Publications (3)

  • Stryjewski ME, Graham DR, Wilson SE, O'Riordan W, Young D, Lentnek A, Ross DP, Fowler VG, Hopkins A, Friedland HD, Barriere SL, Kitt MM, Corey GR; Assessment of Telavancin in Complicated Skin and Skin-Structure Infections Study. Telavancin versus vancomycin for the treatment of complicated skin and skin-structure infections caused by gram-positive organisms. Clin Infect Dis. 2008 Jun 1;46(11):1683-93. doi: 10.1086/587896.

    PMID: 18444791RESULT

  • Wilson SE, O'Riordan W, Hopkins A, Friedland HD, Barriere SL, Kitt MM; ATLAS Investigators. Telavancin versus vancomycin for the treatment of complicated skin and skin-structure infections associated with surgical procedures. Am J Surg. 2009 Jun;197(6):791-6. doi: 10.1016/j.amjsurg.2008.05.012. Epub 2008 Dec 18.

    PMID: 19095213RESULT

  • Stryjewski ME, Barriere SL, O'Riordan W, Dunbar LM, Hopkins A, Genter FC, Corey GR. Efficacy of telavancin in patients with specific types of complicated skin and skin structure infections. J Antimicrob Chemother. 2012 Jun;67(6):1496-502. doi: 10.1093/jac/dks081. Epub 2012 Mar 13.

    PMID: 22416054DERIVED

MeSH Terms

Conditions

Staphylococcal Skin InfectionsStaphylococcal Infections

Interventions

telavancinVancomycin

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

Results Point of Contact

Title
Steve Barriere, Pharm.D., Vice President, Clinical and Medical Affairs
Organization
Theravance, Inc
sbarriere@theravance.com
650-808-6132

Study Officials

  • G. Ralph Corey, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 11, 2005

First Posted

April 12, 2005

Study Start

February 1, 2005

Primary Completion

May 1, 2006

Study Completion

May 1, 2006

Last Updated

January 16, 2019

Results First Posted

February 1, 2010

Record last verified: 2019-01

Locations

US(1)