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Phase II, Open-Label Study to Evaluate the Safety and Efficacy of Daptomycin in the Treatment of Catheter-Related Gram Positive Bloodstream Infections


Phase 2
18 Years
N/A
Not Enrolling
Both
Bloodstream Infection

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Trial Information

Phase II, Open-Label Study to Evaluate the Safety and Efficacy of Daptomycin in the Treatment of Catheter-Related Gram Positive Bloodstream Infections


THE STUDY DRUG:

Daptomycin is an antibiotic designed to treat a variety of bacterial infections that are
difficult to treat.

SCREENING TESTS:

Before you can start treatment on this study, you will have what are called "screening
tests." These tests will help the doctor decide if you are eligible to take part in this
study.

- You will be asked about your medical/surgical history.

- You will be asked about any medications that you may have taken in the past 2 weeks.
You should tell the study doctor or study staff about any medications or therapies you
may be taking while on this study)

- You will have a physical exam, including measurement of your vital signs (heart rate,
temperature, breathing rate, and blood pressure).

- You will have blood drawn (about 1 tablespoon) for routine tests and to check for
bacterial infection. This routine blood sample may be drawn from the CVC, if the CVC
is still in place.

- Your CVC exit site (where the CVC will be removed from) will be examined.

- You may have an echocardiogram (a test that uses sound waves to make pictures of your
heart, which helps show how well your heart pumps blood). 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). Your primary doctor and/or your study doctor
will decide if you will have this test. If you are found to have this inflammation,
you will not be able to take part in this study.

- Women who are able to have children must have a negative blood (about 1 teaspoon) or
urine pregnancy test.

STUDY TREATMENT:

If you are found to be eligible to take part in this study, you will be given daptomycin by
vein over 30 minutes every 24 hours for at least 7-14 days, depending on the type of
bacteria that you have.

The CVC will either be removed, or it will be exchanged over a guide wire. The decision to
remove or exchange the CVC and timing of the placement of the CVC will be decided by your
primary physician and the willingness of you to remove or exchange your infected CVC. This
will be done within 96 hours after your first positive blood culture (first blood drawn that
showed bacteria). A CVC is a sterile flexible tube that will be placed into a large vein
while you are under local anesthesia. Your doctor will explain this procedure to you in
more detail, and you will be required to sign a separate consent form for this procedure.

If the study doctor and/or your primary doctor suspects that you have a mixed infection (2
or more certain types of bacteria) or pneumonia, you will also be treated with different
types of antibiotics, by vein or mouth, in combination with the study drug. These
antibiotics may include aztreonam, cefepime, imipenem, meropenem, ciprofloxacin
hydrochloride, bactrim, and/or amoxicillin/clavulanate (a combination antibiotic).

If you are discharged from the hospital before completing the study medication, arrangements
will be made to provide infusions on an outpatient basis (by a nurse, yourself, or a family
member). You and/or a family member will be taught (by a nurse) how to take the study
medication at home. Before you are discharged from the hospital, you will receive the kits
that include enough supplies for you and/or a family member to give daptomycin by vein. If
medication will be given at home, a prescription will be given to you to pick up your
medication from the pharmacy before you discharge from the hospital. If possible, your
primary doctor may arrange for you to receive medication at the M. D. Anderson outpatient
treatment center, or a nurse will be scheduled to visit you at home to give you the
medication.

STUDY TESTS/PROCEDURES:

During each week of treatment, you will have the following exams/procedures performed once a
week.

- You will have blood drawn (about 1 tablespoon) for routine tests. It may be drawn from
the CVC, if the CVC is still in place. The CVC exit site will be examined at each
visit until you have no more signs or symptoms of infection.

- You will also have blood drawn (about 1 tablespoon) for a blood culture every other day
until it no longer shows signs of infection.

- You will be asked about any symptoms or illnesses that you may have experienced since
your last visit.

LENGTH OF STUDY:

Participation on this study will last for no more than 60 days (about 2 months).

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:

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.

- You will have blood drawn (about 1 tablespoon) 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 experienced since
your last visit.

- You will be asked about any medications or therapies that you may be taking.

This is an investigational study. Daptomycin is FDA approved and commercially available for
the treatment infections of the skin and soft tissue. Its use in this study is
investigational and authorized for use in research only. Up to 40 patients will take part
in this study. All will be enrolled at M. D. Anderson.


Inclusion Criteria:



- Male or non-pregnant, non-lactating females with an age of greater than or equal to
18 years.

- The suspected culprit on exchangeable central venous catheter (CVC) is tunneled or
non-tunnel (including ports and PICC) and antibiotic or non-antibiotic coated
catheter inserted in the subclavian, jugular, peripheral or femoral vein.

- Patients must have at least two signs of sepsis from the list below, in any
combination, within 48 hours prior to Daptomycin therapy and no other source for the
bacteremia other than CVC: 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 or =/<4,000/mm^3
differential count showing >10% band forms; e. Systolic blood pressure =/<90 mm Hg.

- Patients with probable or definite diagnosis of uncomplicated CVC-related gram
positive bacteremia that includes at least one positive blood culture for CNS, SA,
Enterococci, Corynebacterium, and Propionibacterium (If the positive blood culture is
drawn through the CVC for skin flora such as CNS, Corynebacterium, Propionibacterium,
Micrococcus and Bacillus, then at least >15 colonies/ml will be required or the time
of positive (DTP) of CVC at least 2 hours earlier than the peripheral culture).

- Signed informed consent.

- No apparent source for the clinical manifestation of bacteremia other than the
catheter (may have local signs and symptoms at the catheter site).

Exclusion Criteria:

- Estimated Serum Creatinine Clearance <30 mL/min (according to Cock-Gault-formula)at
the time gram positive bacteremia was diagnosed unless the patient is on dialysis.

- Bilirubin >4x the upper limit of normal at the time gram positive bacteremia was
diagnosed.

- Treatment with an antibiotic, such as vancomycin, linezolid, tigecycline or
daptomycin, 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,
leukocytosis, and/or repeated positive blood cultures (CVC and peripheral) for 72
hours or longer of appropriate antibiotics treatment other than Daptomycin.

- Documented gram positive bacteremia within last 1 month due to source other than CVC.

- Patients who have participated in another investigational anti-infective study within
30 days.

- History of hypersensitivity to lipopeptides.

- Presence of additional source of infection with same organism cultured from blood,
eg. endocarditis (as evidenced by vegetations on an echocardiogram), septic
thrombosis.

- Conditions with markedly decreased albumin in plasma (<1.5 g/dl), e.g., cirrhosis,
nephritic syndrome, end-stage renal disease.

- Prosthetic valve.

- Oliguria defined as urine output of <20 cc/hour averaged over 24 hours.

- Possible complicated CRBSI with persistent bacteremia for more than 48 hours on
active antimicrobial therapy (such as osteomyelitis, endocarditis, and septic
thrombosis).

- Patients with diagnosis of pneumonia that is due to S. aureus organism, e.g, S.
aureus from sputum or bronchial cultures.

- CPK >10X max-normal in asymptomatic patients and CPK >5 max-normal in symptomatic
patients.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To find out if daptomycin can help to control CRIs with or without exchange of the central venous catheter (CVC) over a guide wire.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Issam Raad, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2006-0958

NCT ID:

NCT00467272

Start Date:

March 2007

Completion Date:

Related Keywords:

  • Bloodstream Infection
  • Catheter-Related Bloodstream Infections
  • Bloodstream Infection
  • Daptomycin
  • Cubicin
  • CRBSI

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030