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Phase II, Open-Label Study to Evaluate the Safety and Efficacy of Telavancin in the Treatment of Gram Positive Bloodstream Infections in Cancer Patients


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Infection, Bacteremia

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Trial Information

Phase II, Open-Label Study to Evaluate the Safety and Efficacy of Telavancin in the Treatment of Gram Positive Bloodstream Infections in Cancer Patients


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Patient Response to Telavancin

Outcome Description:

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).

Outcome Time Frame:

From baseline up to 6 weeks, assessed every 7 days

Safety Issue:

Yes

Principal Investigator

Issam Raad, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

2010-0454

NCT ID:

NCT01321879

Start Date:

March 2011

Completion Date:

Related Keywords:

  • Infection
  • Bacteremia
  • Gram Positive Bloodstream Infections
  • Sepsis
  • Staphylococcus aureus
  • Enterococci
  • Streptococci
  • Pneumococci
  • Corynebacterium
  • Propionibacterium or Bacillus species
  • Telavancin
  • Vibativ
  • Bacteremia

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030