Study to Evaluate the Safety and Efficacy of Telavancin in the Treatment of Gram Positive Bloodstream Infections in Cancer Patients
Condition: Infection; Bacteremia
MeSH terms: Infections; Communicable Diseases; Bacteremia; Sepsis
Intervention: Telavancin
Intervention description: 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.
Intervention MeSH terms: Telavancin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Gram Positive Bloodstream Infections; Sepsis; Staphylococcus aureus; Enterococci; Streptococci; Pneumococci; Corynebacterium; Propionibacterium or Bacillus species; Telavancin; Vibativ

Summary:

      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).
    

Eligibility criteria:

        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.