Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Serious infections caused by resistant bacteria are becoming more of a medical problem throughout the world. One of the ways to deal with this problem is to develop new drugs that can control these bacteria. This study will measure how well TD-6424 (Telavancin) can control infections and whether this drug can be safely given to patients.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telavancin | Experimental |
| |
| Standard of care for cSSSI | Active Comparator | cSSSI - complicated skin and skin structure infections |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telavancin | Drug | Telavancin 7.5 mg/kg/day IV (intravenously) for up to 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Response Which is Measured at Test of Cure (TOC) in the Clinically Evaluable (CE) Population |
| 7-14 days following end of antibiotic treatment |
Not provided
Not provided
Inclusion Criteria:
Patients must have a diagnosis of one of the following complicated skin and skin structure infections with either a suspected or confirmed Gram positive organism as the major cause of the infection:
Patients must be expected to require at least 4 days of intravenous antibiotic treatment
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| G. Ralph Corey, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| eStudy Site, 3450 Bonita Road, Ste 201 | Chula Vista | California | 91910 | United States |
Not provided
Enrollment Period: 05Jun03 to 20Jan04
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Telavancin | Patients with complicated Gram-positive skin and skin structure infections were randomized to receive telavancin 10 mg/kg/day IV (intravenously) |
| FG001 | Standard of Care for cSSSI |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Vancomycin or antistaphylococcal penicillin | Drug | Vancomycin 1 Gram IV (intravenously) every 12 hrs or nafcillin 2 Grams, oxacillin 2 Grams, or (in South Africa) cloxacillin 0.5 - 1 Gram, IV (intravenously) every 6 hrs for up to 14 days. |
|
Patients with complicated Gram-positive skin and skin structure infections were randomized to receive standard therapy, defined as vancomycin 1 Gram every 12 hours IV (intravenously) or an antistaphylococcal (semisynthetic) penicillin.
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Telavancin | Patients with complicated Gram-positive skin and skin structure infections were randomized to receive telavancin 10 mg/kg/day IV (intravenously) |
| BG001 | Standard of Care for cSSSI | Patients with complicated Gram-positive skin and skin structure infections were randomized to receive standard therapy, defined as vancomycin 1 Gram every 12 hours IV (intravenously) or an antistaphylococcal (semisynthetic) penicillin. |
| BG002 | Total | Total of all reporting groups |
| 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 | 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 |
| ||||||||||||||||||
| Diabetes Status | Number | 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 Which is Measured at Test of Cure (TOC) in the Clinically Evaluable (CE) Population |
| The CE population were a subset of the All Treated Population and was composed of patients who met the inclusion/exclusion criteria or were granted permission to enroll and had a clinical response of "cure" or "failure." The All Treated Population patients received at least one treatment. The Primary Efficacy Analysis was of the CE population. | Posted | Number | participants | 7-14 days following end of antibiotic treatment |
|
|
|
|
Not provided
The Safety Population was the "All Treated Population" - all patients who received one treatment. The Primary Analysis was of the Clinically Evaluable (CE) Population. The CE population was composed of the patients who met the inclusion / exclusion criteria or were granted permission to enroll and had a clinical response of "cure" or "failure".
Not provided
| 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 were randomized to receive telavancin 10 mg/kg/day IV (intravenously) | 3 | 84 | 46 | 84 | ||
| EG001 | Standard of Care for cSSSI | Patients with complicated Gram-positive skin and skin structure infections were randomized to receive standard therapy, defined as vancomycin 1 Gram every 12 hours IV (intravenously) or an antistaphylococcal (semisynthetic) penicillin. | 9 | 83 | 50 | 83 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis | Infections and infestations | Systematic Assessment |
| ||
| Necrotizing Fasciitis | Infections and infestations | Systematic Assessment |
| ||
| Subcutaneous Abscess | Infections and infestations | Systematic Assessment |
| ||
| Wound Abscess | Infections and infestations | Systematic Assessment |
| ||
| Wound Infection | Infections and infestations | Systematic Assessment |
| ||
| Wound dehiscence | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Inguinal mass | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Vaginal Haemorrhage | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Angioneurotic Oedema | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Gangrene | Vascular disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Leukopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Arrhythmia | Cardiac disorders | Systematic Assessment |
| ||
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Keratoconjunctivitis Sicca | Eye disorders | Systematic Assessment |
| ||
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dry Mouth | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dysphasia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Post-Procedural Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Retching | Gastrointestinal disorders | Systematic Assessment |
| ||
| Toothache | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Anasarca | General disorders | Systematic Assessment |
| ||
| Catheter related complication | General disorders | Systematic Assessment |
| ||
| Catheter Site Inflammation | General disorders | Systematic Assessment |
| ||
| Catheter site rash | General disorders | Systematic Assessment |
| ||
| Chest Pain | General disorders | Systematic Assessment |
| ||
| Discomfort | General disorders | Systematic Assessment |
| ||
| Drug Withdrawal Syndrome | General disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Feeling hot | General disorders | Systematic Assessment |
| ||
| Feeling jittery | General disorders | Systematic Assessment |
| ||
| Infusion site pain | General disorders | Systematic Assessment |
| ||
| Injection Site Extravasation | General disorders | Systematic Assessment |
| ||
| Injection site phlebitis | General disorders | Systematic Assessment |
| ||
| Oedema Peripheral | General disorders | Systematic Assessment |
| ||
| Pain | General disorders | Systematic Assessment |
| ||
| Pain exacerbated | General disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Red Man Syndrome | General disorders | Systematic Assessment |
| ||
| Rigors | General disorders | Systematic Assessment |
| ||
| Abscess | Infections and infestations | Systematic Assessment |
| ||
| Bacteriuria | Infections and infestations | Systematic Assessment |
| ||
| Cellulitis | Infections and infestations | Systematic Assessment |
| ||
| Gonorrhea | Infections and infestations | Systematic Assessment |
| ||
| Influenza | Infections and infestations | Systematic Assessment |
| ||
| Localized Infection | Infections and infestations | Systematic Assessment |
| ||
| Nasal abscess | Infections and infestations | Systematic Assessment |
| ||
| Necrotizing Fasciitis | Infections and infestations | Systematic Assessment |
| ||
| Subcutaneous Abscess | Infections and infestations | Systematic Assessment |
| ||
| Superinfection | Infections and infestations | Systematic Assessment |
| ||
| Tinea Pedis | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Tuberculosis | Infections and infestations | Systematic Assessment |
| ||
| Upper Respiratory Infection | Infections and infestations | Systematic Assessment |
| ||
| Urinary Tract Infection | Infections and infestations | Systematic Assessment |
| ||
| Vaginal Candidiasis | Infections and infestations | Systematic Assessment |
| ||
| Wound Abscess | Infections and infestations | Systematic Assessment |
| ||
| Wound infection staphylococcal | Infections and infestations | Systematic Assessment |
| ||
| Blister | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Ligament Injury | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Muscle Strain | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Wound dehiscence | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Alanine Aminotransferase increased | Investigations | Systematic Assessment |
| ||
| Aspartate Aminotransferase increased | Investigations | Systematic Assessment |
| ||
| Blood Alkaline phosphatase increased | Investigations | Systematic Assessment |
| ||
| Blood creatinine increased | Investigations | Systematic Assessment |
| ||
| Blood glucose decreased | Investigations | Systematic Assessment |
| ||
| Blood in stool | Investigations | Systematic Assessment |
| ||
| Blood lactate dehydrogenase increased | Investigations | Systematic Assessment |
| ||
| Blood pressure increased | Investigations | Systematic Assessment |
| ||
| Body temperature increased | Investigations | Systematic Assessment |
| ||
| Gamma-glutamyltransferase increased | Investigations | Systematic Assessment |
| ||
| Hepatic Enzyme increased | Investigations | Systematic Assessment |
| ||
| HIV Test positive | Investigations | Systematic Assessment |
| ||
| Liver function test abnormal | Investigations | Systematic Assessment |
| ||
| Anorexia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Diabetes Mellitus | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypoglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypokalaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypomagnesaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyponatremia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Inguinal mass | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Neck Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Pain in Extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Uterine Leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Burning sensation | Nervous system disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Hypoaesthesia | Nervous system disorders | Systematic Assessment |
| ||
| Migraine | Nervous system disorders | Systematic Assessment |
| ||
| Paraesthesia | Nervous system disorders | Systematic Assessment |
| ||
| Somnolence | Nervous system disorders | Systematic Assessment |
| ||
| Tremor | Nervous system disorders | Systematic Assessment |
| ||
| Agitation | Psychiatric disorders | Systematic Assessment |
| ||
| Anxiety | Psychiatric disorders | Systematic Assessment |
| ||
| Confusional State | Psychiatric disorders | Systematic Assessment |
| ||
| Depression | Psychiatric disorders | Systematic Assessment |
| ||
| Disorientation | Psychiatric disorders | Systematic Assessment |
| ||
| Euphoric Mood | Psychiatric disorders | Systematic Assessment |
| ||
| Insomnia | Psychiatric disorders | Systematic Assessment |
| ||
| Irritability | Psychiatric disorders | Systematic Assessment |
| ||
| Restlessness | Psychiatric disorders | Systematic Assessment |
| ||
| Schizophrenia | Psychiatric disorders | Systematic Assessment |
| ||
| Albuminuria | Renal and urinary disorders | Systematic Assessment |
| ||
| Diabetic neuropathy | Renal and urinary disorders | Systematic Assessment |
| ||
| Haematuria | Renal and urinary disorders | Systematic Assessment |
| ||
| Microalbuminuria | Renal and urinary disorders | Systematic Assessment |
| ||
| Urinary Incontinence | Renal and urinary disorders | Systematic Assessment |
| ||
| Genital Pruritis Female | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Vaginal Haemorrhage | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Asthma | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Crackles Lung | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hiccups | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Rhonchi | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Wheezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Acne | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Angioneurotic Oedema | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Dermatitis contact | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Dry Skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Hyperhidrosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Night sweats | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Photosensitivity Reaction | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Pruritis | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash pruritic | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Skin Burning sensation | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Skin Irritation | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Skin Ulcer | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Urticaria | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Flushing | Vascular disorders | Systematic Assessment |
| ||
| Gangrene | Vascular disorders | Systematic Assessment |
| ||
| Hot Flush | Vascular disorders | Systematic Assessment |
| ||
| Hypertension | Vascular disorders | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
| ||
| Peripheral Ischaemia | Vascular disorders | Systematic Assessment |
| ||
| Phlebitis | Vascular disorders | Systematic Assessment |
| ||
| Thrombophlebitis | Vascular disorders | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steve Barriere, Pharm.D., Vice President, Clinical and Medical Affairs | Theravance, Inc | 650-808-6132 | sbarriere@theravance.com |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D000038 | Abscess |
| D002056 | Burns |
| D002481 | Cellulitis |
| D014456 | Ulcer |
| D014946 | Wound Infection |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D013492 | Suppuration |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |
| D012874 | Skin Diseases, Infectious |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C487637 | telavancin |
| D014640 | Vancomycin |
| ID | Term |
|---|---|
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| South Africa |
|
| Non-Diabetic |
|
| Indeterminate |
|