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Study 0018 (NCT00107978) compares the safety and effectiveness of an investigational drug, telavancin, and an approved drug, vancomycin, for the treatment of complicated skin and skin structure infections.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telavancin | Experimental |
| |
| Vancomycin | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telavancin | Drug | Telavancin 10 mg/kg/day, IV for up to 14 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Response | The Clinical Response for each patient was determined by the investigator by assessing the patient's clinical signs & symptoms compared with the Baseline evaluation. Cure: resolution of signs and symptoms associated with the skin infection present at study admission such that no further antibiotic therapy was necessary; Not Cured: inadequate response to study therapy; Indeterminate: unable to determine outcome. | 7 to 14 days after the last antibiotic dose |
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Inclusion Criteria:
Patients must have a diagnosis of one of the following complicated skin and skin structure infections with MRSA (Methicillin-resistant Staphylococcus Aureus) either suspected or confirmed as the major cause of the infection:
Patients must be expected to require at least 7 days of intravenous antibiotic treatment.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| G. Ralph Corey, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Louisiana State University Health Sciences Center, Dept of Med/ER Med | New Orleans | Louisiana | 70112 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18444791 | Result | Stryjewski ME, Graham DR, Wilson SE, O'Riordan W, Young D, Lentnek A, Ross DP, Fowler VG, Hopkins A, Friedland HD, Barriere SL, Kitt MM, Corey GR; Assessment of Telavancin in Complicated Skin and Skin-Structure Infections Study. Telavancin versus vancomycin for the treatment of complicated skin and skin-structure infections caused by gram-positive organisms. Clin Infect Dis. 2008 Jun 1;46(11):1683-93. doi: 10.1086/587896. | |
| 19095213 |
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Enrollment Period: 18 February 2005 to 31 May 2006
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| ID | Title | Description |
|---|---|---|
| FG000 | Telavancin | Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV once daily. The maximum allowable treatment period was 14 days. |
| FG001 | Vancomycin |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Vancomycin | Drug | Vancomycin 1 Gm IV administered every 12 hrs for up to 14 days. |
|
| Result |
| Wilson SE, O'Riordan W, Hopkins A, Friedland HD, Barriere SL, Kitt MM; ATLAS Investigators. Telavancin versus vancomycin for the treatment of complicated skin and skin-structure infections associated with surgical procedures. Am J Surg. 2009 Jun;197(6):791-6. doi: 10.1016/j.amjsurg.2008.05.012. Epub 2008 Dec 18. |
| 22416054 | Derived | Stryjewski ME, Barriere SL, O'Riordan W, Dunbar LM, Hopkins A, Genter FC, Corey GR. Efficacy of telavancin in patients with specific types of complicated skin and skin structure infections. J Antimicrob Chemother. 2012 Jun;67(6):1496-502. doi: 10.1093/jac/dks081. Epub 2012 Mar 13. |
Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive vancomycin 1 Gm every 12 hours. The maximum allowable treatment period was 14 days. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Telavancin | Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV once daily. The maximum allowable treatment period was 14 days. |
| BG001 | Vancomycin | Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive vancomycin 1 Gm every 12 hours. The maximum allowable treatment period was 14 days. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Diabetes Status | Number | Participants |
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| 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 | The Clinical Response for each patient was determined by the investigator by assessing the patient's clinical signs & symptoms compared with the Baseline evaluation. Cure: resolution of signs and symptoms associated with the skin infection present at study admission such that no further antibiotic therapy was necessary; Not Cured: inadequate response to study therapy; Indeterminate: unable to determine outcome. | Data for the all-treated population (AT) are presented. The AT and clinically evaluable (CE) populations were considered co-primary. | Posted | Number | patients | 7 to 14 days after the last antibiotic dose |
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Safety data includes data from all patients treated. Efficacy data does not include data from three sites. Hence, there is a discrepancy between the total numbers of patients in each arm in the safety data vs. the efficacy data.
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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 complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV once daily. The maximum allowable treatment period was 14 days. | 38 | 503 | 377 | 503 | ||
| EG001 | Vancomycin | Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive vancomycin 1 Gm every 12 hours. The maximum allowable treatment period was 14 days. | 15 | 509 | 341 | 509 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Renal Failure Acute | Renal and urinary disorders | Systematic Assessment |
| ||
| Myocardial Infarction | Cardiac disorders | Systematic Assessment |
| ||
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Blood creatinine increased | Investigations | Systematic Assessment |
| ||
| Drug Hypersensitivity | Immune system disorders | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
| ||
| Mental Status Changes | Psychiatric disorders | Systematic Assessment |
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| Renal Insufficiency | Renal and urinary disorders | Systematic Assessment |
| ||
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Blood Urea increased | Investigations | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
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| Osteomyelitis | Infections and infestations | Systematic Assessment |
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| Peripheral Occlusive Disease | Vascular disorders | Systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Abscess Soft Tissue | Infections and infestations | Systematic Assessment |
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| Alveolitis Allergic | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Anaphylactic Reaction | Immune system disorders | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Brain Stem Infarction | Nervous system disorders | Systematic Assessment |
| ||
| Cardiac Arrest | Cardiac disorders | Systematic Assessment |
| ||
| Cardio-Respiratory Arrest | Cardiac disorders | Systematic Assessment |
| ||
| Cholecystitis | Hepatobiliary disorders | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Erythema Multiforme | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Gangrene | Vascular disorders | Systematic Assessment |
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| Hepatic Cirrhosis | Hepatobiliary disorders | Systematic Assessment |
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| Hypersensitivity | Immune system disorders | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Intervertebral Discitis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Malaise | General disorders | Systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | Systematic Assessment |
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| Non-Accidental Overdose | Injury, poisoning and procedural complications | Systematic Assessment |
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| Orthostatic Hypotension | Vascular disorders | Systematic Assessment |
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| Sepsis | Infections and infestations | Systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | Systematic Assessment |
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| Acute Myocardial Infarction | Cardiac disorders | Systematic Assessment |
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| Alanine Aminotransferase increased | Investigations | Systematic Assessment |
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| Ascites | Gastrointestinal disorders | Systematic Assessment |
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| Aspartate Aminotransferase increased | Investigations | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | Systematic Assessment |
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| Cardiogenic Shock | Cardiac disorders | Systematic Assessment |
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| Gastrointestinal Infection | Infections and infestations | Systematic Assessment |
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| Hip Fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Infusion site reaction | General disorders | Systematic Assessment |
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| Pain in Extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Peripheral Ischaemia | Vascular disorders | Systematic Assessment |
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| Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pyrexia | General disorders | Systematic Assessment |
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| Renal Failure Chronic | Renal and urinary disorders | Systematic Assessment |
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| Rigors | General disorders | Systematic Assessment |
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| Septic Shock | Infections and infestations | Systematic Assessment |
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| Soft Tissue Injury | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
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| Dry Mouth | Gastrointestinal disorders | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
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| Loose stools | Gastrointestinal disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Asthenia | General disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Infusion site erythema | General disorders | Systematic Assessment |
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| Infusion site pain | General disorders | Systematic Assessment |
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| Infusion site phlebitis | General disorders | Systematic Assessment |
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| Infusion site pruritis | General disorders | Systematic Assessment |
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| Infusion site reaction | General disorders | Systematic Assessment |
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| Pyrexia | General disorders | Systematic Assessment |
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| Rigors | General disorders | Systematic Assessment |
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| Drug Hypersensitivity | Immune system disorders | Systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | Systematic Assessment |
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| Vaginal mycosis | Infections and infestations | Systematic Assessment |
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| Alanine Aminotransferase increased | Investigations | Systematic Assessment |
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| Aspartate Aminotransferase increased | Investigations | Systematic Assessment |
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| Blood Creatinine Increased | Investigations | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | Systematic Assessment |
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| Somnolence | Nervous system disorders | Systematic Assessment |
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| Anxiety | Psychiatric disorders | Systematic Assessment |
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| Insomnia | Psychiatric disorders | Systematic Assessment |
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| Renal Failure Acute | Renal and urinary disorders | Systematic Assessment |
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| Urine Abnormality | Renal and urinary disorders | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pharyngolaryngeal Pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Pruritis | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Pruritis generalized | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Flushing | Vascular disorders | Systematic Assessment |
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| Hypertension | Vascular disorders | Systematic Assessment |
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| Hypotension | Vascular disorders | 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 |
| ID | Term |
|---|---|
| D013207 | Staphylococcal Skin Infections |
| D013203 | Staphylococcal Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D017192 | Skin Diseases, Bacterial |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C487637 | telavancin |
| D014640 | Vancomycin |
| ID | Term |
|---|---|
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| South Africa |
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| Argentina |
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| Canada |
|
| Chile |
|
| France |
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| Germany |
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| Italy |
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| Korea, Republic of |
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| Lithuania |
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| Peru |
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| Poland |
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| Spain |
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| Taiwan |
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| United Kingdom |
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| Not diabetic |
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| Indeterminate |
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| Missing |
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