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Halted due to lack of statistical power. No safety concerns identified.
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This is a multicenter, randomized, open-label, noninferiority trial of telavancin versus standard IV therapy control (e.g., vancomycin, daptomycin, anti-staphylococcal penicillin (PCN), or cefazolin) in the treatment of subjects with complicated Staphylococcus aureus (S. aureus) bacteremia and SA right-sided infective endocarditis (SA-RIE).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telavancin | Experimental | 7.5 mg/kg administered intravenously once every 24 hours daily over 60 minutes |
|
| Standard of care | Active Comparator | Vancomycin, Daptomycin, synthetic penicillin or Cefazolin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telavancin | Drug |
| ||
| Vancomycin |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Clinical Outcome of Cure at Test of Cure (TOC) | The efficacy endpoint of clinical outcome of cure at the test of cure (TOC) was determined by subjects who meet all of the following criteria, as determined by the investigator and adjudicated by the blinded independent efficacy adjudication committee (IEAC).
| Up to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With an Investigator Clinical Outcome of Cure at TOC in the Microbiological All-treated (mAT) Population | The efficacy endpoint of Investigator clinical outcome of cure at the test of cure (TOC) was determined by the following criteria:
|
Not provided
Inclusion Criteria:
18 years of age or older with at least one blood culture positive for S. aureus within 48 hours before randomization
At least one of the following signs or symptoms of bacteremia:
At enrollment, subjects must have either 1) known right-sided infective endocarditis by Modified Duke's criteria 2) known complicated bacteremia, demonstrated as signs or symptoms of metastatic foci of S. aureus infection or 3) at least one risk factor for complicated bacteremia.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Cumberland Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Remington-Davis Clinical Research | Columbus | Ohio | 43215 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Telavancin | 7.5 mg/kg administered intravenously once every 24 hours daily over 60 minutes Telavancin |
| FG001 | Standard of Care | Vancomycin, Daptomycin, synthetic penicillin or Cefazolin Vancomycin Daptomycin Synthetic penicillin Cefazolin |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Demographic (All-Treated Population)
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| ID | Title | Description |
|---|---|---|
| BG000 | Telavancin | 7.5 mg/kg administered intravenously once every 24 hours daily over 60 minutes Telavancin |
| BG001 | Standard of Care | Vancomycin, Daptomycin, synthetic penicillin or Cefazolin Vancomycin Daptomycin Synthetic penicillin Cefazolin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants With a Clinical Outcome of Cure at Test of Cure (TOC) | The efficacy endpoint of clinical outcome of cure at the test of cure (TOC) was determined by subjects who meet all of the following criteria, as determined by the investigator and adjudicated by the blinded independent efficacy adjudication committee (IEAC).
| One subject enrolled was excluded from all summaries and analyses because the subject was randomized to a higher dose of telavancin (10mg/kg) that the remainder of the subjects. | Posted | Count of Participants | Participants | Up to 8 weeks |
|
38 months
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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 | 7.5 mg/kg administered intravenously once every 24 hours daily over 60 minutes Telavancin |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA®; version 18 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA®; version 18 | Non-systematic Assessment |
At the interim analysis, study was deemed to be inadequately powered & terminated prematurely.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Director of Clinical and Regulatory Affairs | Cumberland Pharmaceuticals Inc. | 615-255-0068 | ahaeberle@cumberlandpharma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 16, 2018 | Oct 16, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 26, 2018 | Oct 16, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D016470 | Bacteremia |
| D013203 | Staphylococcal Infections |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D018805 | Sepsis |
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| ID | Term |
|---|---|
| C487637 | telavancin |
| D014640 | Vancomycin |
| D017576 | Daptomycin |
| D009254 | Nafcillin |
| D010068 | Oxacillin |
| D003023 | Cloxacillin |
| D002437 | Cefazolin |
| ID | Term |
|---|---|
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
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|
| Daptomycin | Drug |
|
|
| Synthetic penicillin | Drug |
|
|
| Cefazolin | Drug |
|
| Up to 8 weeks |
| Investigator Clinical Response (Success or Failure) at EOT in the Microbiological All-treated (mAT) Population | This efficacy endpoint was determined to be a clinical failure if the subject switched study antibiotic due to lack of clinical response | Up to 8 weeks |
| Number of Participants With the Development of a New Metastatic Foci of S. Aureus Infection at Test of Cure (TOC) in the Microbiological All-treated (mAT) Populations | After Day 8, any sign or symptom leading to a subsequent confirmed diagnosis of a new metastatic foci of S. aureus infection | Day 8 |
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 | Standard of Care | Vancomycin, Daptomycin, synthetic penicillin or Cefazolin Vancomycin Daptomycin Synthetic penicillin Cefazolin |
|
|
| Secondary | Number of Participants With an Investigator Clinical Outcome of Cure at TOC in the Microbiological All-treated (mAT) Population | The efficacy endpoint of Investigator clinical outcome of cure at the test of cure (TOC) was determined by the following criteria:
| One subject enrolled was excluded from all summaries and analyses because the subject was randomized to a higher dose of telavancin (10mg/kg) that the remainder of the subjects. | Posted | Count of Participants | Participants | Up to 8 weeks |
|
|
|
| Secondary | Investigator Clinical Response (Success or Failure) at EOT in the Microbiological All-treated (mAT) Population | This efficacy endpoint was determined to be a clinical failure if the subject switched study antibiotic due to lack of clinical response | One subject enrolled was excluded from all summaries and analyses because the subject was randomized to a higher dose of telavancin (10mg/kg) that the remainder of the subjects. | Posted | Count of Participants | Participants | Up to 8 weeks |
|
|
|
| Secondary | Number of Participants With the Development of a New Metastatic Foci of S. Aureus Infection at Test of Cure (TOC) in the Microbiological All-treated (mAT) Populations | After Day 8, any sign or symptom leading to a subsequent confirmed diagnosis of a new metastatic foci of S. aureus infection | One subject enrolled was excluded from all summaries and analyses because the subject was randomized to a higher dose of telavancin (10mg/kg) that the remainder of the subjects. | Posted | Count of Participants | Participants | Day 8 |
|
|
|
| 3 |
| 58 |
| 16 |
| 58 |
| 29 |
| 58 |
| EG001 | Standard of Care | Vancomycin, Daptomycin, synthetic penicillin or Cefazolin Vancomycin Daptomycin Synthetic penicillin Cefazolin | 5 | 60 | 13 | 60 | 25 | 60 |
| Cardiac failure | Cardiac disorders | MedDRA®; version 18 | Non-systematic Assessment |
|
| Cardiovascular insufficiency | Cardiac disorders | MedDRA®; version 18 | Non-systematic Assessment |
|
| Multi-organ failure | General disorders | MedDRA®; version 18 | Non-systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA®; version 18 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA®; version 18 | Non-systematic Assessment |
|
| Unintentional medical device removal | General disorders | MedDRA®; version 18 | Non-systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA®; version 18 | Non-systematic Assessment |
|
| Osteomyelitis | Infections and infestations | MedDRA®; version 18 | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA®; version 18 | Non-systematic Assessment |
|
| Arthritis bacterial | Infections and infestations | MedDRA®; version 18 | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA®; version 18 | Non-systematic Assessment |
|
| Escherichia bacteraemia | Infections and infestations | MedDRA®; version 18 | Non-systematic Assessment |
|
| Extradural abscess | Infections and infestations | MedDRA®; version 18 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA®; version 18 | Non-systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA®; version 18 | Non-systematic Assessment |
|
| Serratia infection | Infections and infestations | MedDRA®; version 18 | Non-systematic Assessment |
|
| Spinal empyema | Infections and infestations | MedDRA®; version 18 | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA®; version 18 | Non-systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA®; version 18 | Non-systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA®; version 18 | Non-systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA®; version 18 | Non-systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA®; version 18 | Non-systematic Assessment |
|
| Malignant peritoneal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA®; version 18 | Non-systematic Assessment |
|
| Brain oedema | Nervous system disorders | MedDRA®; version 18 | Non-systematic Assessment |
|
| Encephalopathy | Nervous system disorders | MedDRA®; version 18 | Non-systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA®; version 18 | Non-systematic Assessment |
|
| Tubulointerstitial nephritis | Renal and urinary disorders | MedDRA®; version 18 | Non-systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA®; version 18 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA®; version 18 | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA®; version 18 | Non-systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA®; version 18 | Non-systematic Assessment |
|
| Shock | Vascular disorders | MedDRA®; version 18 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA®; version 18 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA®; version 18 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA®; version 18 | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA®; version 18 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA®; version 18 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA®; version 18 | Non-systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA®; version 18 | Non-systematic Assessment |
|
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| D018746 |
| Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016908 | Gram-Positive Bacterial Infections |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D055666 | Lipopeptides |
| D008055 | Lipids |
| 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 |
| D002511 | Cephalosporins |
| D013843 | Thiazines |
| Indeterminate |
|
| Missing |
|
| Indeterminate |
|
| Missing |
|
| Indeterminate |
|