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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telavancin | Experimental |
| |
| Vancomycin, nafcillin, oxacillin, or cloxacillin | Active Comparator | Vancomycin 1 Gram/12 hours or nafcillin, oxacillin, or cloxacillin 2 Gram/6 hours (IV) intravenously |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telavancin | Drug | Telavancin 10mg/kg/day IV every 24 hrs for up to 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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
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| Name | Affiliation | Role |
|---|---|---|
| G. Ralph Corey, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wellstar Infectious Disease | Marietta | Georgia | 30060 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24884578 | Derived | 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. |
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Enrollment period: 14 Aug 2003 to 02 Aug 2006
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| ID | Title | Description |
|---|---|---|
| FG000 | Telavancin | Patients with uncomplicated Staphylococcus aureus bacteremia were randomized to receive telavancin 10 mg/kg/day IV (intravenously) every 12 hrs for up to 14 days. Excludes 1 patient who never started therapy. |
| FG001 | Standard Therapy | Patients with uncomplicated Staphylococcus aureus bacteremia were randomized to receive vancomycin 1 Gram IV (intravenously) every 12 hrs OR nafcillin, oxacillin, or cloxacillin 2 Gram IV (intravenously) every 6 hrs for up to 14 days. Excludes one patient who never started therapy. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Telavancin | Patients with uncomplicated Staphylococcus aureus bacteremia were randomized to receive telavancin 10 mg/kg/day IV (intravenously) every 12 hrs for up to 14 days. Excludes 1 patient who never started therapy. |
| BG001 | Standard Therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The primary efficacy analysis was of the CE Population, defined as those patients meeting meeting inclusion/exclusion criteria, meeting continuation criteria, receiving assigned study drug for at least 14 days and available for assessment of response. | Posted | Number | participants | 12 weeks after start of treatment |
|
From receipt of first dose through last follow-up assessment (up to Day 98).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Telavancin | Patients with uncomplicated Staphylococcus aureus bacteremia were randomized to receive telavancin 10 mg/kg/day IV (intravenously) every 12 hrs for up to 14 days. Excludes 1 patient who never started therapy. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | MeDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MeDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steve Barriere, Pharm.D., Vice President, Clinical and Medical Affairs | Theravance, Inc | 650-808-6132 | sbarriere@theravance.com |
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| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C487637 | telavancin |
| D014640 | Vancomycin |
| D009254 | Nafcillin |
| D010068 | Oxacillin |
| D003023 | Cloxacillin |
| ID | Term |
|---|---|
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
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| Vancomycin, nafcillin, oxacillin, or cloxacillin | Drug | 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. |
|
| Withdrawal by Subject |
|
| Protocol Violation |
|
| Lost to Follow-up |
|
| Failed continuation criteria |
|
| Other |
|
| Never received study treatment |
|
Patients with uncomplicated Staphylococcus aureus bacteremia were randomized to receive vancomycin 1 Gram IV (intravenously) every 12 hrs OR nafcillin, oxacillin, or cloxacillin 2 Gram IV (intravenously) every 6 hrs for up to 14 days. Excludes one patient who never started therapy. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Standard Therapy | Patients with uncomplicated Staphylococcus aureus bacteremia were randomized to receive vancomycin 1 Gram IV (intravenously) every 12 hrs OR nafcillin, oxacillin, or cloxacillin 2 Gram IV (intravenously) every 6 hrs for up to 14 days. Excludes one patient who never started therapy. |
|
|
|
| 11 |
| 29 |
| 26 |
| 29 |
| EG001 | Standard Therapy | Patients with uncomplicated Staphylococcus aureus bacteremia were randomized to receive vancomycin 1 Gram IV (intravenously) every 12 hrs OR nafcillin, oxacillin, or cloxacillin 2 Gram IV (intravenously) every 6 hrs for up to 14 days. Excludes one patient who never started therapy. | 6 | 29 | 21 | 29 |
| Nausea | Gastrointestinal disorders | MeDRA | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MeDRA | Systematic Assessment |
|
| Adverse Drug Reaction | General disorders | MeDRA | Systematic Assessment |
|
| Death | General disorders | MeDRA | Systematic Assessment |
|
| Multi-organ Failure | General disorders | MeDRA | Systematic Assessment |
|
| Neuroleptic Malignant Syndrome | General disorders | MeDRA | Systematic Assessment |
|
| Pyrexia | General disorders | MeDRA | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MeDRA | Systematic Assessment |
|
| Endocarditis | Infections and infestations | MeDRA | Systematic Assessment |
|
| Endocarditis bacterial | Cardiac disorders | MeDRA | Systematic Assessment |
|
| Lobar Pneumonia | Infections and infestations | MeDRA | Systematic Assessment |
|
| Sepsis | Infections and infestations | MeDRA | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MeDRA | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MeDRA | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MeDRA | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MeDRA | Systematic Assessment |
|
| Syncope vasovagal | Nervous system disorders | MeDRA | Systematic Assessment |
|
| Mental Status Changes | Psychiatric disorders | MeDRA | Systematic Assessment |
|
| Renal Failure Acute | Renal and urinary disorders | MeDRA | Systematic Assessment |
|
| Renal Failure Chronic | Renal and urinary disorders | MeDRA | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MeDRA | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MeDRA | Systematic Assessment |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MeDRA | Systematic Assessment |
|
| Respiratory Tract Congestion | Respiratory, thoracic and mediastinal disorders | MeDRA | Systematic Assessment |
|
| Deep Vein Thrombosis | Vascular disorders | MeDRA | Systematic Assessment |
|
| Eosinophilia | Blood and lymphatic system disorders | MeDRA | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MeDRA | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MeDRA | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MeDRA | Systematic Assessment |
|
| Catheter site erythema | General disorders | MeDRA | Systematic Assessment |
|
| Pyrexia | General disorders | MeDRA | Systematic Assessment |
|
| Catheter site infection | Infections and infestations | MeDRA | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MeDRA | Systematic Assessment |
|
| Urinary Tract Infection Fungal | Infections and infestations | MeDRA | Systematic Assessment |
|
| Blood Urea increased | Investigations | MeDRA | Systematic Assessment |
|
| Eosinophil Count increased | Investigations | MeDRA | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | MeDRA | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MeDRA | Systematic Assessment |
|
| Headache | Nervous system disorders | MeDRA | Systematic Assessment |
|
| Agitation | Psychiatric disorders | MeDRA | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MeDRA | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MeDRA | Systematic Assessment |
|
| Pruritis | Skin and subcutaneous tissue disorders | MeDRA | Systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | MeDRA | Systematic Assessment |
|
| Deep Vein Thrombosis | Vascular disorders | MeDRA | Systematic Assessment |
|
| Phlebitis | Vascular disorders | MeDRA | Systematic Assessment |
|
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| D000602 |
| Amino Acids, Peptides, and Proteins |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |