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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01321879
Recruitment Status : Completed
First Posted : March 24, 2011
Last Update Posted : December 7, 2016
Theravance Biopharma Antibiotics, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief 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.


Evaluate the clinical efficacy and safety of Telavancin given for treatment of gram positive bacteremia in cancer patients (including neutropenics).

Condition or disease Intervention/treatment Phase
Infection Bacteremia Drug: Telavancin Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II, Open-Label Pilot Study to Evaluate the Safety and Efficacy of Telavancin in the Treatment of Gram Positive Bloodstream Infections in Cancer Patients
Study Start Date : March 2011
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Telavancin
10 or 7.5 mg/kg intravenous daily
Drug: Telavancin
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.
Other Name: Vibativ

Primary Outcome Measures :
  1. Patient Response to Telavancin [ Time Frame: From baseline up to 6 weeks, assessed every 7 days ]
    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).

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01321879

United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Theravance Biopharma Antibiotics, Inc.
Principal Investigator: Issam Raad, MD M.D. Anderson Cancer Center

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT01321879     History of Changes
Other Study ID Numbers: 2010-0454
NCI-2011-00752 ( Registry Identifier: NCI CTRP )
First Posted: March 24, 2011    Key Record Dates
Last Update Posted: December 7, 2016
Last Verified: December 2016

Keywords provided by M.D. Anderson Cancer Center:
Gram Positive Bloodstream Infections
Staphylococcus aureus
Propionibacterium or Bacillus species

Additional relevant MeSH terms:
Communicable Diseases
Bacterial Infections
Systemic Inflammatory Response Syndrome
Pathologic Processes
Anti-Bacterial Agents
Anti-Infective Agents