NCT00062647

Brief Summary

The purpose of this study is to determine whether telavancin (TD-6424, ARBELIC) can be safety administered to patients with bloodstream infections and whether telavancin is effective in treating these infections.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2003

Typical duration 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

First Submitted

Initial submission to the registry

June 9, 2003

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 12, 2003

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2003

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
4.6 years until next milestone

Results Posted

Study results publicly available

March 22, 2011

Completed
Last Updated

January 16, 2019

Status Verified

January 1, 2019

Enrollment Period

3 years

First QC Date

June 9, 2003

Results QC Date

December 2, 2009

Last Update Submit

January 14, 2019

Conditions

Gram-Positive Bacterial Infections

Outcome Measures

Primary Outcomes (1)

  • Clinical Response (Cure, Failure, or Indeterminate) as Determined by the Investigator Based the Presence or Absence of Clinical Signs and Symptoms Associated With Bacteremia, Metastatic Complications, or Positive Culture at the Test of Cure Evaluation

    Outcomes in this exploratory study were compared for noninferiority though no specific margin was justified. The 95% CI for the difference was -35.5 to 31.9; further statistical evaluation is not warranted owing to the small sample size.

    12 weeks after start of treatment

Study Arms (2)

Telavancin

EXPERIMENTAL
Drug: Telavancin

Vancomycin, nafcillin, oxacillin, or cloxacillin

ACTIVE COMPARATOR

Vancomycin 1 Gram/12 hours or nafcillin, oxacillin, or cloxacillin 2 Gram/6 hours (IV) intravenously

Drug: Vancomycin, nafcillin, oxacillin, or cloxacillin

Interventions

TelavancinDRUG

Telavancin 10mg/kg/day IV every 24 hrs for up to 14 days

Also known as: TD-6424, VIBATIV
Telavancin
Vancomycin, nafcillin, oxacillin, or cloxacillinDRUG

Vancomycin 1 Gram every 12 hr IV (intravenously) OR nafcillin, oxacillin, or cloxacillin 2 Grams every 6 hr IV (intravenously) for up to 14 days.

Vancomycin, nafcillin, oxacillin, or cloxacillin

Eligibility Criteria

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

You may qualify if:

  • \- Documented S. aureus bacteremia

You may not qualify if:

  • \- Patients who had received or would have received more than 72 hours of potentially effective systemic antistaphylococcal therapy within 7 days prior to randomization. The following agents were considered potentially effective antistaphylococcal therapy: antistaphylococcal penicillins (including nafcillin, oxacillin, or cloxacillin), cephalosporins, fluoroquinolones, glycopeptides (including vancomycin and teicoplanin) and linezolid

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wellstar Infectious Disease

Marietta, Georgia, 30060, United States

Location

Related Publications (1)

  • Stryjewski ME, Lentnek A, O'Riordan W, Pullman J, Tambyah PA, Miro JM, Fowler VG Jr, Barriere SL, Kitt MM, Corey GR. A randomized Phase 2 trial of telavancin versus standard therapy in patients with uncomplicated Staphylococcus aureus bacteremia: the ASSURE study. BMC Infect Dis. 2014 May 23;14:289. doi: 10.1186/1471-2334-14-289.

    PMID: 24884578DERIVED

MeSH Terms

Conditions

Gram-Positive Bacterial Infections

Interventions

telavancinVancomycinNafcillinOxacillinCloxacillin

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

GlycopeptidesGlycoconjugatesCarbohydratesPeptidesAmino Acids, Peptides, and ProteinsPenicillinsbeta-LactamsLactamsAmidesOrganic ChemicalsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

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 2
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

June 9, 2003

First Posted

June 12, 2003

Study Start

August 1, 2003

Primary Completion

August 1, 2006

Study Completion

August 1, 2006

Last Updated

January 16, 2019

Results First Posted

March 22, 2011

Record last verified: 2019-01

Locations

US(1)