Telavancin for Treatment of Uncomplicated Staphylococcus Aureus Bacteremia - Full Text View

Purpose

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.

Condition	Intervention	Phase
Gram-Positive Bacterial Infections	Drug: Telavancin Drug: Vancomycin, nafcillin, oxacillin, or cloxacillin	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Phase 2, Randomized, Double-Blind, Parallel-Group, Multinational Trial of Intravenous Televancin (TD-6424) for Treatment of Uncomplicated Staphylococcus Aureus Bacteremia

Resource links provided by NLM:

Drug Information available for: Oxacillin Nafcillin Cloxacillin Sodium Nafcillin sodium Oxacillin sodium Vancomycin Vancomycin hydrochloride Telavancin Telavancin hydrochloride

U.S. FDA Resources

Further study details as provided by Theravance Biopharma Antibiotics, Inc.:

Primary Outcome Measures:

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 [ Time Frame: 12 weeks after start of treatment ] [ Designated as safety issue: No ]
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.


Enrollment:	60
Study Start Date:	August 2003
Study Completion Date:	August 2006
Primary Completion Date:	August 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Telavancin	Drug: Telavancin Telavancin 10mg/kg/day IV every 24 hrs for up to 14 days Other Names: TD-6424 VIBATIV
Active Comparator: Vancomycin, nafcillin, oxacillin, or cloxacillin Vancomycin 1 Gram/12 hours or nafcillin, oxacillin, or cloxacillin 2 Gram/6 hours (IV) intravenously	Drug: Vancomycin, nafcillin, oxacillin, or cloxacillin 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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

- Documented S. aureus bacteremia

Exclusion Criteria

- 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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00062647

Locations


United States, Georgia
Wellstar Infectious Disease
Marietta, Georgia, United States, 30060

Sponsors and Collaborators

Theravance Biopharma Antibiotics, Inc.

Investigators


Principal Investigator:	G. Ralph Corey, MD	Duke University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Stryjewski ME, Lentnek A, O'Riordan W, Pullman J, Tambyah PA, Miró 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.


Responsible Party:	Steven L. Barriere, Pharm.D., Vice President, Clinical and Medical Affairs, Theravance, Inc.
ClinicalTrials.gov Identifier:	NCT00062647 History of Changes
Other Study ID Numbers:	I6424-203a
Study First Received:	June 9, 2003
Results First Received:	December 2, 2009
Last Updated:	March 30, 2011
Health Authority:	Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Argentina: Human Research Bioethics Committee Argentina: Ministry of Health Hong Kong: Department of Health Hong Kong: Ethics Committee Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee Singapore: Clinical Trials & Epidemiology Research Unit (CTERU) Singapore: Domain Specific Review Boards Singapore: Health Sciences Authority Spain: Comité Ético de Investigación Clínica Spain: Ethics Committee Spain: Ministry of Health Spain: Ministry of Health and Consumption Spain: Spanish Agency of Medicines United States: Food and Drug Administration

Additional relevant MeSH terms:


Bacterial Infections Bacteremia Gram-Positive Bacterial Infections Sepsis Infection Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes	Vancomycin Telavancin Cloxacillin Oxacillin Nafcillin Anti-Bacterial Agents Anti-Infective Agents

ClinicalTrials.gov processed this record on September 28, 2016

Telavancin for Treatment of Uncomplicated Staphylococcus Aureus Bacteremia (ASSURE)