NCT00107952

Brief Summary

Study 0015 (NCT00107952) compares the safety and effectiveness of an investigational drug, telavancin, with vancomycin for the treatment of hospital-acquired pneumonia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
761

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Feb 2005

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
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

December 8, 2009

Completed
Last Updated

January 16, 2019

Status Verified

January 1, 2019

Enrollment Period

2.4 years

First QC Date

April 11, 2005

Results QC Date

November 3, 2009

Last Update Submit

January 14, 2019

Conditions

Bacterial Pneumonia

Keywords

Nosocomial pneumoniaMRSA

Outcome Measures

Primary Outcomes (1)

  • Clinical Response

    Clinical Response: Categorical (Cured, Failed or Indeterminate) * Failure is at least one of the following: Persistence or progression of signs and symptoms of pneumonia that still require antibiotic therapy; Termination of study med due to "lack of efficacy"; Death on or after Day 3 attributable to primary infection * Cure: Signs and symptoms of pneumonia improved to the point that no further antibiotics for pneumonia were required, and baseline radiographic findings improved or did not progress. * Indeterminate: Inability to determine outcome

    7 - 14 days following end of antibiotic treatment

Study Arms (2)

Telavancin

EXPERIMENTAL
Drug: Telavancin

Vancomycin

ACTIVE COMPARATOR
Drug: Vancomycin

Interventions

TelavancinDRUG

Telavancin 10 mg/kg/day IV for up to 21 days.

Also known as: TD-6424, VIBATIV
Telavancin
VancomycinDRUG

Vancomycin 1 Gm IV q 12 hrs for up to 21 days

Vancomycin

Eligibility Criteria

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

You may qualify if:

  • Clinical signs and symptoms consistent with pneumonia acquired after at least 48 hours of continuous stay in an inpatient acute or chronic care facility or acquired within 7 days after being discharged from a hospitalization of greater than or equal to 3 days duration.

You may not qualify if:

  • Received more than 24 hours of potentially effective systemic (IV, IM or PO) antibiotic therapy for Gram-positive pneumonia immediately prior to randomization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

Related Publications (3)

  • McKinnell JA, Corman S, Patel D, Leung GH, Gordon LM, Lodise TP. Effective Antimicrobial Stewardship Strategies for Cost-effective Utilization of Telavancin for the Treatment of Patients With Hospital-acquired Bacterial Pneumonia Caused by Staphylococcus aureus. Clin Ther. 2018 Mar;40(3):406-414.e2. doi: 10.1016/j.clinthera.2018.01.010. Epub 2018 Feb 15.

    PMID: 29454592DERIVED

  • Smart JI, Corey GR, Stryjewski ME, Wang W, Barriere SL. Assessment of Minimum Inhibitory Concentrations of Telavancin by Revised Broth Microdilution Method in Phase 3 Hospital-Acquired Pneumonia/Ventilator-Associated Pneumonia Clinical Isolates. Infect Dis Ther. 2016 Dec;5(4):535-544. doi: 10.1007/s40121-016-0133-y. Epub 2016 Oct 7.

    PMID: 27718118DERIVED

  • Barriere SL, Stryjewski ME, Corey GR, Genter FC, Rubinstein E. Effect of vancomycin serum trough levels on outcomes in patients with nosocomial pneumonia due to Staphylococcus aureus: a retrospective, post hoc, subgroup analysis of the Phase 3 ATTAIN studies. BMC Infect Dis. 2014 Apr 4;14:183. doi: 10.1186/1471-2334-14-183.

    PMID: 24708675DERIVED

MeSH Terms

Conditions

Pneumonia, BacterialHealthcare-Associated Pneumonia

Interventions

telavancinVancomycin

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesCross InfectionIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

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 Biopharma Antibiotics, 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

July 1, 2007

Study Completion

July 1, 2007

Last Updated

January 16, 2019

Results First Posted

December 8, 2009

Record last verified: 2019-01

Locations

US(1)