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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-00752 | Registry Identifier | NCI CTRP |
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| Name | Class |
|---|---|
| Theravance Biopharma | INDUSTRY |
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The goal of this clinical research study is to learn if Vibativ (telavancin) can help to control blood stream infections (BSIs). The safety of this treatment will also be studied.
Objectives:
Evaluate the clinical efficacy and safety of Telavancin given for treatment of gram positive bacteremia in cancer patients (including neutropenics).
The Study Drug:
Telavancin is an antibiotic designed to treat a variety of bacterial infections that are difficult to treat.
Central Venous Catheter (CVC):
A CVC is a sterile flexible tube could have been placed into a large vein while you were under local anesthesia.
If you have a certain type of infection, your doctor may decided to remove or exchange your CVC. The decision to remove or exchange the CVC and timing of the placement of the new CVC will be decided by your primary doctor.
If you are to get a new CVC, your doctor will explain this procedure to you in more detail, and you will be required to sign a separate consent form.
Study Treatment:
If you are found to be eligible to take part in this study, you will receive telavancin by vein over a period of 60 minutes once daily for at least 7 days and for up to 6 weeks. How long you receive the study drug will depend on the type of bacterial infection that you have and if your doctor thinks you may have a complicated bacterial infection of the blood.
If the doctor thinks that you have a mixed infection (2 or more certain types of bacteria), you may also be given another type of antibiotic (such as aztreonam, cefepime, imipenem, meropenem, ciprofloxacin hydrochloride, bactrim, piperacillin/tazobactam and/or amoxicillin/clavulanate).
If the doctor thinks it is needed, you will have an echocardiogram to check your heart function. This test will only be performed if you have a specific type of infection (to make sure you do not have inflammation in the lining of the heart). You will be asked about medications you are taking.
If you are discharged from the hospital before completing the study drug, you will be able to take the drug as an outpatient. Your primary doctor may arrange for you to receive medication at M. D. Anderson.
Study Visits:
Once a week:
Every other day, blood (about 1 tablespoon) will be drawn to check for the infection until it no longer shows signs of infection. Kidney function will be monitored by performing a blood test every 2 days for the first week and weekly after that.
Length of Study:
You can receive the study drug for up to 6 weeks. You will be taken off this study if the infection gets worse or any intolerable side effects occur.
End-of-Study Visit and Follow-up Visit:
You will need to return to MD Anderson for your end of treatment visit, within 7 days after you last dose of study drug. The end-of-study visit will occur within 7 days after your last dose of the study drug.
The follow-up visit will occur about 32 days (about 1 month) after your last dose of the study drug. At each of these visits, you will have the following exams/procedures performed.
This is an investigational study. Telavancin is FDA approved and commercially available for the treatment infections of the skin and soft tissue. Its use to treat blood infections in this study is investigational.
Up to 40 patients will take part in this study. All will be enrolled at M. D. Anderson.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telavancin | Experimental | 10 or 7.5 mg/kg intravenous daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telavancin | Drug | 10 mg/kg by vein once daily for patients with a creatinine clearance of more than 50 ml/min, and a dose of 7.5 mg/kg once daily for patients with a creatinine clearance of 30-50 ml/min. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Clinical Response to Telavancin | Clinical response assessed: Cure (No fever/chills or symptoms + eradication causing organism); Improvement (Resolution local/systemic symptoms + no new systemic antibacterial treatment); Failure (IF one or more following: Persistence 1+ symptoms [fever/chills] + new systemic anti gram positive treatment, > 72 hours after initiation study drug; or Relapse within 1 month completing antibiotic therapy; or Development of deep-seated infection not previously assessed); Indeterminate (clinical signs and symptoms cannot be assessed). | From baseline up to 6 weeks, assessed every 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Issam Raad, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26482312 | Derived | Chaftari AM, Hachem R, Jordan M, Garoge K, Al Hamal Z, El Zakhem A, Viola GM, Granwehr B, Mulanovich V, Gagel A, Reitzel R, Yousif A, Jiang Y, Raad I. Case-Control Study of Telavancin as an Alternative Treatment for Gram-Positive Bloodstream Infections in Patients with Cancer. Antimicrob Agents Chemother. 2015 Oct 19;60(1):239-44. doi: 10.1128/AAC.00617-15. Print 2016 Jan. |
| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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One participant was excluded from the study because of a failed screening test result and did not receive treatment.
Recruitment Period: March 2011 and May 2013. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Telavancin | Telavancin 10 mg/kg intravenous (IV) once daily for patients with a creatinine clearance of more than 50 ml/min, and a dose of 7.5 mg/kg once daily for patients with a creatinine clearance of 30-50 ml/min. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Telavancin | Telavancin 10 mg/kg intravenous (IV) once daily for patients with a creatinine clearance of more than 50 ml/min, and a dose of 7.5 mg/kg once daily for patients with a creatinine clearance of 30-50 ml/min. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Patient Clinical Response to Telavancin | Clinical response assessed: Cure (No fever/chills or symptoms + eradication causing organism); Improvement (Resolution local/systemic symptoms + no new systemic antibacterial treatment); Failure (IF one or more following: Persistence 1+ symptoms [fever/chills] + new systemic anti gram positive treatment, > 72 hours after initiation study drug; or Relapse within 1 month completing antibiotic therapy; or Development of deep-seated infection not previously assessed); Indeterminate (clinical signs and symptoms cannot be assessed). | Three patients received <72 hours of Telavancin treatment and therefore were excluded from the efficacy analysis. | Posted | Count of Participants | Participants | From baseline up to 6 weeks, assessed every 7 days |
|
Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
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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 | Telavancin 10 mg/kg intravenous (IV) once daily for patients with a creatinine clearance of more than 50 ml/min, and a dose of 7.5 mg/kg once daily for patients with a creatinine clearance of 30-50 ml/min. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intracerebellar bleed | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Issam I. Raad/ Chair, Infectious Diseases | UT MD Anderson Cancer Center | 713- 792-7943 | iraad@mdanderson.org |
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| ID | Term |
|---|---|
| D007239 | Infections |
| D016470 | Bacteremia |
| D018805 | Sepsis |
| D013203 | Staphylococcal Infections |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
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| ID | Term |
|---|---|
| C487637 | telavancin |
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|
| Withdrawal by Subject |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 7 |
| 39 |
| 15 |
| 39 |
| 31 |
| 39 |
| Fever | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Neutropenic fever | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Intraabdominal hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hepatic failure | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypotension | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Acute Renal Injury | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Tumor lysis syndrome | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Bowel obstruction | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Bloodstream infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Acute coronary syndrome | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Neuropathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Sepsis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Acute coronary syndrome | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Alanine aminotransferase increased | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Alkaline phosphatase increased | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Anorexia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Blood and lymphatic system disorders - (Other) | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Bruising | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Confusion | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Creatinine increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Edema face | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Edema limbs | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Esophageal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Eye disorders - (Other) | Eye disorders | CTCAE (4.0) | Systematic Assessment | Inflammed |
|
| Fall | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fever | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Floaters | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Gastrointestinal disorders | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hematoma | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hematuria | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hemorrhoidal hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hepatic failure | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hepatic hemorrhage | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hepatitis viral | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypermagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyperuricemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Infections and infestations - (Other) | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Intracranial hemorrhage | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Menorrhagia | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Mucositis oral | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Pelvic infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Platelet count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Psychiatric disorders - (Other) | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Scrotal infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Sepsis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Sinusitis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Skin and subcutaneous tissue disorders - (Other) | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Skin infection | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Soft tissue infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Surgical and medical procedures - (Other) | Surgical and medical procedures | CTCAE (4.0) | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Vaginal hemorrhage | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Vascular access complication | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| White blood cell decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Wound infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
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| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016908 | Gram-Positive Bacterial Infections |