Study to Evaluate the Safety and Efficacy of Telavancin in the Treatment of Gram Positive Bloodstream Infections in Cancer Patients
Study to Evaluate the Safety and Efficacy of Telavancin in the Treatment of Gram Positive Bloodstream Infections in Cancer Patients
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:

 -  Blood (about 1 tablespoon) will be drawn for routine tests. It may be drawn from the
 CVC, if the CVC is still in place.

 -  The CVC exit site will be checked at each visit until you have no more signs or symptoms
 of infection.

 -  You will be asked about any symptoms or illnesses that you may have had since your last
 visit.

 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.

 -  You will have a physical exam, including measurement of your vital signs.

 -  Blood (about 1 tablespoon) will be drawn for routine tests and to check for bacterial
 infection. The blood sample may be drawn from the CVC, if the CVC is still in place. The
 CVC exit site will be examined.

 -  You will be asked about any symptoms or illnesses that you may have had since your last
 visit.

 -  You will be asked about any drugs or therapies that you may be taking until the end of
 your treatment.

 -  If your infection recurs during the follow-up period, and if the doctor thinks it is
 needed, you will have an echocardiogram to check your heart function and to make sure
 you do not have inflammation in the lining of the heart.

 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.
Inclusion Criteria:

 1. Patients with probable or definite diagnosis of uncomplicated gram positive bacteremia
 that have at least one positive blood culture including 20 patients with
 Staphylococcus aureus and the other 20 patients will include any of the following
 organism ( CNS, Enterococci, streptococci, pneumococci, Corynebacterium, and
 Propionibacterium or Bacillus species).If the positive blood culture involves a
 commensal skin organism such as CNS, Corynebacterium, Propionibacterium, Micrococcus
 and Bacillus, then at least > 100 colonies/ml will be required or a time to positivity
 =/< 16 hours (as it has been shown to reflect a high grade bacteremia), or two
 positive blood cultures. (Time to positivity of a blood culture bottle is recorded in
 the microbiology laboratory by the automatic culture detector (Bactec 9240 and Bactec
 Plus Aerobic/F; Becton Dickinson) which records culture positivity every 15 min
 according to changes in fluorescence related to microbial growth).

 2. Patients must have at least two signs of sepsis from the list below, in any
 combination at any time, within 48 hours prior to Telavancin therapy: a. Core
 temperature =/>38.0 degrees C or =/<36.0 degrees C, measured orally, rectally,
 tympanic ally or via a central catheter. If auxiliary add 0.5 degrees C to the
 measured temperature; b. Pulse rate =/> 100 beats/min.; c. Respiratory rate =/>
 20/min.; d. WBC count =/>12,000/mm^3, =/<4,000/mm or differential count showing >10%
 band forms; e. Systolic blood pressure =/<90 mm Hg. Patient will still be eligible for
 the study if the participants white blood cell count (WBC) is outside normal limits
 due to chemotherapy treatment or underlying conditions.

 3. Male or non-pregnant, non-lactating females with an age of greater than or equal to 18
 years.

 4. Signed informed consent.

 5. Female patients must be at no risk for pregnancy for one of the following reasons: -
 Postmenopausal for at least one year - Post-hysterectomy and/or post-bilateral
 ovariectomy - If of childbearing potential, having a negative serum human chorionic
 gonadotropin (hCG) pregnancy test with in 5 days prior to enrollment and be using a
 highly effective method of birth control throughout the course of the study. Reliable
 sexual abstinence throughout the course of the study is acceptable as a highly
 effective method of birth control for the purposes of this study.

 Exclusion Criteria:

 1. Estimated Serum Creatinine Clearance <30 mL/min (according to Cock-Gault-formula using
 ideal body weight) at the time gram positive bacteremia was diagnosed unless the
 patient is on dialysis.

 2. Bilirubin >4x the upper limit of normal at the time gram positive bacteremia was
 diagnosed.

 3. Treatment with an antibiotic, such as vancomycin, linezolid, tigecycline or
 Telavancin, effective against resistant gram positive bacterial infections, such as
 methicillin resistant staphylococci, for more than 48 hours within 72 hours of study
 medication initiation, unless treatment failed that is defined as a persistent fever
 and/or leukocytosis for 72 hours or longer of appropriate antibiotics treatment.

 4. History of hypersensitivity to lipoglycopeptides.

 5. Presence of deep-sited intravascular source of infection with same organism cultured
 from blood, e.g. endocarditis (as evidenced by vegetations on an echocardiogram), or
 septic thrombosis.

 6. Presence of a prosthetic valve.

 7. Oliguria defined as urine output of <20 cc/hour averaged over 24 hours.