Safety and Efficacy of Telavancin

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Theravance, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01321879
First received: March 17, 2011
Last updated: June 10, 2013
Last verified: June 2013
  Purpose

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).


Condition Intervention Phase
Infection
Bacteremia
Drug: Telavancin
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II, Open-Label Study to Evaluate the Safety and Efficacy of Telavancin in the Treatment of Gram Positive Bloodstream Infections in Cancer Patients

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Patient Response to Telavancin [ Time Frame: From baseline up to 6 weeks, assessed every 7 days ] [ Designated as safety issue: Yes ]
    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).


Estimated Enrollment: 40
Study Start Date: March 2011
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01321879

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Theravance, Inc.
Investigators
Principal Investigator: Issam Raad, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01321879     History of Changes
Other Study ID Numbers: 2010-0454
Study First Received: March 17, 2011
Last Updated: June 10, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Gram Positive Bloodstream Infections
Sepsis
Staphylococcus aureus
Enterococci
Streptococci
Pneumococci
Corynebacterium
Propionibacterium or Bacillus species
Telavancin
Vibativ

Additional relevant MeSH terms:
Bacteremia
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014