Clinical trial NCT01321879
Conditions: Infection Bacteremia
Keywords: Gram Positive Bloodstream Infections Sepsis Staphylococcus aureus Enterococci Streptococci Pneumococci Corynebacterium Propionibacterium or Bacillus species Telavancin Vibativ
Sponsor: M.D. Anderson Cancer Center
Start date: 2011-03-01; Completion date: 2016-12-01
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

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.

Objectives:

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

Detailed description:
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.

Arms: arm 1: 10 or 7.5 mg/kg intravenous daily
Interventions: intervention 1: Telavancin
Intervention descriptions: intervention 1: 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.

Protocol documents: